Free On-Demand Webinar: Speed to Clinic
Learn more about how time can be saved during process development providing you with greater speed to clinic. Our webinar is available for you to view on-demand – for free.
Standard Disposables Design™ (SDD™)
Buffer and media preparation are common in the production of antibody and proteinbased therapeutics, antibiotics, and vaccines. So the Standard Disposables Design™ (SDD™) initiative has been launched to concentrate on standardizing disposables for these applications. Read about PM Group’s vision to have most major biopharmaceutical companies store their media and buffers in the same design of disposable bags.
Raising the Bar for Upstream Processing
Read this conversation with Stefan Schlack and Christel Fenge to learn about current market trends. Our experts summarize the key themes of our last European Upstream and Downstream Forum and talk about how our upstream solutions support customers, from concept to commercial production, to accelerate product development and scale-up.
Active Dashboard 2 Allows Easy Access to Process Performance Data
We have launched the Active Dashboard 2, an advanced software solution. Delivering in-depth insights into process performance across the manufacturing network, the release helps managerial staff to achieve better timely decisions, ensuring superior manufacturing success. Read more about the benefits of the Active Dashboard 2 in our product news.
New Tools for Optimizing Custom Media Design
At last year's European Upstream & Downstream Technology Forum, Michael Gillmeister presented independent case studies of a media optimization program offered jointly by Lonza and Sartorius Stedim Biotech. The program uses an ambr® 15 microbioreactor system to generate custom media that are chemically defined and contain no products of animal origin.
New Generation of Single-Use Bioreactors Can Reduce Bioprocess Development Time and Cost
Our new BIOSTAT STR® bioreactor range featuring upgraded hardware and software, as well as a fully integrated, new design of Flexsafe STR® single-use bags, ensures quick and easy bioprocess scale-up of biologics and vaccines. Read the full SelectScience® article:
What Is the Best Way to Approach Biosimilar Development?
To demonstrate biosimilarity it is essential that the biological product has been proven to be highly similar to the originator product and has no clinically meaningful differences in terms of its safety and efficacy. Read this blog entry to learn about the best practices for biosimilar development.
Virus Production Using Single-Use Bioreactors
The veterinary pharmaceutical company HIPRA needed to rapidly expand the production capacity and faced the dilemma of installing more of the tried-and-tested stainless steel bioreactor capacity or opting instead for single-use bioreactors (with which HIPRA had no previous experience). The company decided to purchase single-use bioreactors from Sartorius Stedim Biotech. Read how HIPRA benefits from this decision.
GEN Article: Strategies to Overcome Modular Design Challenges
New processes and innovative technologies are enablers for more efficient and cost-effective drug development and manufacturing. In this GEN article, Thorsten Peuker, Vice President Integrated Solutions at Sartorius Stedim Biotech, focuses on single-use technologies and their effect on the design of facilities, highlighting modular approaches.
Case Study: End-to-End, GMP Production Platform for Synthon’s Biologics Pipeline
The international pharmaceutical company Synthon selected Sartorius Stedim Biotech (SSB) as a supplier of single-use processing equipment for both upstream and downstream processing. They were able to leverage SSB’s expertise to support the equipment design for the facility such that SSB provided detailed process flow diagrams, equipment layouts and designs for both systems and consumables. Read the case study.
Interview: Continuous or Intensified Bioprocessing? The Gold Standard for Improved Productivity
In this interview, our Platform Marketing Manager for Continuous Biomanufacturing Gerben Zijlstra explains the difference between intensified and continuous bioprocessing and shares his experience regarding the adoption of the processes by the industry.
Options for Cell Cultivation
Rentschler Biotechnologie GmbH is a contract development and manufacturing organization specialized in the production of therapeutic proteins, listing more than 280 projects to its credit. Read this article to learn about the company’s experience with various alternatives for the cultivation of Chinese hamster ovary (CHO) cells – the cell line of choice for most bioprocessing protocols, including simple batch, fedbatch, chemostat use, and perfusion.
Efficient Integration of Single-Use Equipment During Capacity Expansion Projects
More than ever before, biopharmaceutical companies are able to establish their own in-house biomanufacturing capabilities. In this blog entry, our Technical Content Marketing Manager Dr. Nick Hutchinson writes about the importance of good engineering practices and presents a six step process for successful installing single-use bioproduction capacity.
Spanish webinar on new single-use benchtop bioreactor for PD June 29, 2017
Join us for this live webinar in Spanish on Thursday 29th June to find out more about this exciting new product development, including system performance and application data. Get more information and register today.
Evaluation of Technology for Upscaling Design
The challenge to speed the move to the clinic was considered by Dr. Jincal Li, executive director of process development at WuXi Biologics (part of WuXi AppTec Ltd). Li’s team has extensive experience with our ambr® high-throughput singleuse bioreactor system. Learn how the ambr® technology helps the company fulfill the demands for rapid scale-up.
Sartorius Stedim Biotech Launches ambr® 15 Bioreactor System with Nova BioProfile® FLEX2 Integration
We combined our ambr® 15 automated micro bioreactor system with a Nova Biomedical BioProfile® FLEX2 automated cell culture analyzer. This newly integrated system enables rapid at-line sample collection and analysis of massive quantities of key cell culture data. Read our press release.
A Comprehensive Range of Chemistry Testing Services
We offer a comprehensive range of methods to characterize protein structure, carbohydrate profile, post-translational modifications and impurities, by utilizing state-of-the-art techniques following ICH Q6B scientific guidelines. This results in an efficient streamlined development process for our clients. Discover our expertise.
Webinar Jun 29: Biosimilars – Lessons Learned
Join our webinar to develop a deeper understanding of how structure affects the functional activity of monoclonal antibodies and how this can be used to make data-driven decisions throughout development. You will also learn more about how a QbD approach ensures a step-wise, orthogonal process to de-risk development and improve speed to market. Sign up now.
ambr® Automation Reduces Variance, Improves Data Quality
Mira Drolshagen, an upstream process project engineer at Boehringer Ingelheim, evaluated our ambr® 250 platform. The critical question was whether the ambr® technology is an accurate model of large-scale bioreactor performance. Find out more about the results of Drohshagen's thorough investigation here.
Webinar Jun 16: Discovering the Umetrics™ Suite – Interactive Performance Insight; Web Based Production Overview
The Umetrics™ Suite of Data Analytics Solutions is now expanded with Active Dashboard, a web based solution that collects and analyzes product and process data related to your product quality. Register now for our webinar about Active Dashboard to learn about SIMCA-online values for product performance and process performance monitoring and see a live demo of Active Dashboard.
June 20-22, 2017 – Shanghai, China: CPhI China 2017
CPhI China brings together more than 40,000 pharmaceutical professionals from 120 countries around the world. Visit our team there at booth N1C10 and get to know our current upstream innovations.
Free On-Demand Webinar: Increased Titers
Watch our on-demand webinar and learn how to increase your titers by developing your own optimized media and feeds in 5 months. Dr Vitaly Klimovich (Field Application Specialist, North America) describes how clients have used our CHOptimizer® service to generate 4-fold increases in titer and 2.5-fold increases in viable cell densities.
Interview: Assessing Antibody-Dependent Cell-Mediated Cytotoxicity
Dr. Catriona Thomson, Director of R&D and Technical Services at Sartorius Stedim BioOutsource, spoke to Pharmaceutical Technology about the challenges of developing and validating an ADCC methodology, including the difference between the classical ADCC assay and the reporter bioassay. Read the full interview here.
Webinar Jun 9: Discovering the Umetrics™ Suite – Automatic Optimization with Supervisory Process Control
Register for this webinar about SIMCA-online – part of the Umetrics™ Suite. The webinar will focus on how to create and apply the advanced analytical methods needed to control different aspects of a process. Customer examples will show just how much that can be gained by applying these methods.
June 14-17, 2017 – Boston, MA, USA: ISSCR 2017 Annual Meeting
The ISSCR annual meeting brings together stem cell researchers from around the world to share their work, discuss tools and techniques, and learn about the latest developments in stem cell science. Meet our experts at the event and find out how we can help your business. Booth 740.
Webinar Jun 7: Fast Track to Your QbD Approach
Join our free webinar to learn how you can establish your design space with fully automated mini-bioreactors. We will also talk about the optimization of your process with advanced benchtop bioreactors and will show you how you can simplify data analysis and knowledge management across scales. Register now:
Article: As Easy as ADCC
Extensive regulatory requirements for analytical characterization are now needed to prove comparability between innovator and biosimilar drugs. As a result, many developers are turning to ADCC assays which can help to unpick the issues of similarity as well as to guide the design process to create molecules to target specific activity. Read this article to learn more about the importance of ADCC in biosimilar development.
June 5-7, 2017 – San Diego, CA, USA: Cell Line Development & Engineering
Join us for Cell Line Development & Engineering event in San Diego to investigate advances in genome editing technologies and their application in cell line development. Attend our workshop on June 5 (12 pm) to learn how to lower your cost of goods by improving your product titers. Also don't miss our presentation "Applying QbD Principles in Discovery and Early Stage Process Development Facilitates the Scale-Up of Robust Processes" (June 7, 11 am).
Sartorius Stedim Biotech Partners with Nova Biomedical
Sartorius and Nova Biomedical combine ambr® technology with the BioProfile® FLEX to allow massive quantities of cell culture data to be collected during upstream processing QbD studies. Read the press release here:
Article: Advances in Biosimilars – Best Practices
The mAb structure-function relationship is vital to developments in biosimilar research. By selecting the right assays at the right time, it is possible to significantly reduce the amount of wasted resources in the production process. Read our European Biopharmaceutical Review article to find out more about the advances in biosimilar development.
May 23-24, 2017 – San Diego, CA, USA: World Biosimilar Congress USA 2017
This year's World Biosimilar Congress USA offers an expanded agenda featuring two dedicated streams – one for the business and strategic end, and the other for the analytical and manufacturing challenges that still exist on the scientific end. Use the opportunity to meet our team and talk about current challenges and solutions in biosimilar development.
May 23-24, 2017 – San Diego, CA, USA: Cell Culture World Congress USA 2017
With keynotes, interactive discussions and roundtables, the Cell Culture World Congress is designed to tackle the most important challenges facing the bioprocessing industry. Be part of the event and discover our upstream solutions live. We are looking forward to meeting you.
Sartorius Newsletter: Get Just the News You Really Want
Subscribe to our newsletter to stay informed about our upstream solutions, interesting events, current promotion deals and best practices. You can customize your subscription preferences or unsubscribe at any time. Choose the bioprocess topics you really care about: filtration, fluid management, single-use systems, process control, fermentation | cell culture, purification or service – it's all up to you!
Exciting Workshops and Presentations at ESACT 2017
At the 25th ESACT meeting, we cordially invite you to attend our informative workshop presentations which will take place on May 15-17. We will talk about cell culture clarification, benefits of a platform technology approach, viral contamination risk mitigation in upstream and lots of other exciting topics. Turn up early to secure a place.
Webinar May 19: Discovering the Umetrics™ Suite – Applying and Using Advanced Analytics Models in Real-Time
SIMCA-online from Sartorius Stedim Data Analytics monitors your processes in real time, providing you with a continuous snapshot of your operations. Attend this webinar on May 19 to learn about the Umetrics™ Suite's long-lasting history and knowledge in this field, find out the values you can gain using the SIMCA-online system, and get an overview of the current system capabilities and the future trends.
Rely on Robust Commercial Manufacturing Processes
Avoid batch failures with our robust upstream processing technologies. Rely on the dependability of our BIOSTAT STR® bioreactors and strength of our Flexsafe STR® without compromising on cell growth. Mitigate against virus contamination risks and ensure successful bioreactor harvests with body feed technology.
25th ESACT: Attend our Pre-Conference Speed to Clinic Symposium on May 14
We have assembled leading industry experts from the likes of Novartis and mAbXience to describe state-of-the-art methods for accelerating biopharmaceutical development and increasing speed to clinic. Attend our pre-conference symposium at ESACT 2017 on May 14, 2:00-3:30 pm, to hear more. Auditorium C.
Dive Into the Connect Upstream Virtual Experience
Discover Connect Upstream on a completely new level: Open the following link on your smartphone, put on a pair of VR glasses and dive into another reality! You don’t have any VR glasses at hand? No worries, our virtual Connect Upstream application is also available for 360° use on your smartphone, tablet or desktop.
May 14-17, 2017 – Lausanne, Switzerland: 25th ESACT Meeting
The theme of the upcoming ESACT meeting will be "cell technologies for innovative therapies". At the event, you will have the opportunity to discover the latest tools, technologies and services provided in the field of animal cell technology. Our experts are looking forward to seeing you at the Sartorius Stedim Biotech booth #54.
Webinar May 5: Analyzing Batch Process Data, a Step-by-Step Guide
Sartorius Stedim Data Analytics invites you to a webinar on the Umetrics™ Suite and using OPLS for batch process modeling in SIMCA and SIMCA-online. The webinar is aimed at providing hands on quick introduction to SIMCA 14.1 and its operation to analyze process data that is coming from manufacturing lines. Register here:
May 1-5, 2017 – Boston, MA, USA: PEGS – The Essential Protein & Antibody Engineering Summit
PEGS Summit will provide you with an exclusive platform for networking with world-class experts from pharma, academia, and government. Meet our team at the event to discuss the latest advances in automated single-use bioreactor systems and process analytical technologies. Commonwealth Hall – Booth 404.
Conference Review: Raising the Bar for Upstream Processing
Last year, Sartorius hosted the European Upstream & Downstream Technology Forum in Goettingen, Germany. In cooperation with BioProcess International, a comprehensive conference review has been put together providing videos with external speaker interviews, presentations and scientific summary articles. Review the conference now:
Discover Our Upstream Solutions Now at the BPI European Summit (Booth 110)
Today and tomorrow, our experts are welcoming you at the BioProcess International European Summit in Amsterdam. Meet us at booth 110 to discover our integrated platform for upstream processes live. Learn how we can help you increase your speed to clinic, generate increased titers, implement Quality by Design and build robust production facilities. Also don't miss our exiting presentations about process development, viral safety, cell line engineering, vaccine manufacturing & more.
April 26-27, 2017 – Shanghai, China: 4th Pathogen Clean Asian Forum
The Pathogen Clean Asian Forum 2017 aims to build up and facilitate the progressive regulatory, scientific and technical communication to advocate the safety and quality profiles of bio-therapeutics in the region. Meet our experts there to learn all about our cutting-edge products and services for the development, quality assurance and production processes of the biopharmaceutical industry.
April 26-27, 2017 – New Jersey, USA: Umetrics™ Suite User Meeting 2017
Join us at the Umetrics™ Suite User Meeting to find out how you can benefit from working with the solutions in the Umetrics™ Suite. Listen to customer presentations, share your ideas and network with all the users. Also meet our data analytics experts and get your questions answered.
April 25-27, 2017 – Amsterdam, The Netherlands: Viral Safety
As part of the BPI European Summit, the Viral Safety conference allows you to experience new ideas and innovations across all phases of viral safety. At the event, we will share our knowledge about virus detection and removal with you. Don't miss the presentation by our Junior Product Manager Birte Kleindienst about "Fully single-use for virus filtration in manufacturing - New concepts and strategies" (Apr 25, 12:15).
Sartorius Acquires PAT and QbD Software Partner Umetrics
Sartorius Stedim Biotech acquired MKS Instruments AB (formerly known as Umetrics) based in Malmö, Sweden. Umetrics is a leading specialist in data analytics software for modeling and optimizing biopharmaceutical development and manufacturing processes. The software company has already been cooperating with Sartorius for around five years. Read this article by BioPharma Reporter to learn more:
April 19-21, 2017 – Qingdao, China: CIPM – China International Pharmaceutical Machinery Exposition
CIPM is China’s largest leading show of pharmaceutical industry. Use the opportunity to meet our experts there on April 19-22, and discover our fully integrated upstream platform as well as our latest technologies and services. We're looking forward to welcoming you.
BIOSTAT STR® + Flexsafe STR®: A Perfect Match for True Scalability in Single Use
Our BIOSTAT STR® fully scalable, single-use bioreactor family is now available in its 2nd generation with improved hardware design and Flexsafe STR® bags. Watch our video to see how both solutions work perfectly together – for excellent cell growth and robustness as well as with single-use, non-invasive biomass monitoring.
April 25-26, 2017 – Amsterdam, The Netherlands: BPI European Summit
The BioProcess International European Summit is Europe's most complete bioprocessing conference connecting more than 800 decision makers and scientists from upstream, downstream, cell line development, analytics, viral safety and vaccines. See us presenting and exhibiting at the event. Our experts will hold exiting presentations about process development, cell line engineering, vaccine manufacturing & more. Learn how we can help you increase your speed to clinic and build robust production facilities. Booth 110.
Rapid USP Development with ambr®250, High-Throughput Design and Analysis Tools
A new BPI white paper explores using our ambr®250 (24-way) bioreactor system in combination with high-throughput analytics tools (e.g. the Cedex BioHT analyser and Caliper electrophoresis system) to enable a rapid analysis of samples. Read the white paper now.
April 3-6, 2017 – Barcelona, Spain: ISPE 2017 Europe Annual Conference
ISPE 2017 Europe Annual Conference will focus on "Pharma Manufacturing 2025" and the way to achieve a modern, agile, and flexible production landscape. Meet our team at the event to learn more about our fully integrated upstream platform and further bioprocessing solutions.
April 3-5, 2017 – Anaheim, CA, USA: 2017 PDA Annual Meeting
The theme of this year's PDA Annual Meeting is "Manufacturing Innovation: The Next Wave of Sterile and Biopharmaceutical Science, Technologies and Processing". Be part of the event to learn how industry is applying novel approaches for development and commercialization of pharmaceutical and biopharmaceutical products. We look forward to sharing our upstream knowledge with you.
Webinar May 10: Innovative Process Development Tools Increase Speed-To-Clinic
Join our free webinar on May 10, 2017, to learn how you can save time during process development. We will demonstrate the latest technologies for the creation of a robust and efficient cell line, high throughput tools such as the ambr® systems for cell culture optimization and scale up. Register now!
April 2-6, 2017 – San Francisco, CA, USA: 253rd ACS National Meeting & Exposition
With over 300 exhibitors showcasing state-of-the-art technologies and 14,000 papers featuring cutting-edge research, the ACS National Meeting is the perfect platform for you to share ideas with thousands of the best chemical professionals in the world. Meet the Sartorius team there at booth 321 to gain more insights into our latest upstream solutions.
Case Study: State of the Art Flexible Factory with Hybrid Commercial Manufacturing Process for Recombinant Proteins
With a facility designed and constructed by Sartorius' Integrated Solutions team, DMBio satisfies global GMP standards and aims to be one of the main players in the future global biologics market. Thanks to redundancy for the automation architecture from upstream to downstream, with single-use and multi-use process equipment, the facility is compliant with with the highest possible standards of process safety and traceability. Read the full case study here:
March 15-16, 2017 – Mexico City, Mexico: Biomédicas - Feria de Proveedores
At the 2a Feria de Proveedores de la Facultad de Medicina (UNAM), Sartorius will display its latest upstream solutions. Take the chance to visit our stand and to talk to our experienced experts. We are looking forward to welcoming you.
March 14, 2017 – Raleigh, NC, USA: Life Sciences Technology Conference
ISPE-CaSA 24th Life Sciences Technology Conference will capture innovative technologies and industry best practices that have been recently developed and employed to successfully meet the growing complexities of drug manufacturing. Visit us at booth 232 to learn more about our integrated solutions which cover fermentation, cell cultivation, filtration and fluid management as well as purification and lab technologies.
Video: Cost Modelling of Bioprocesses by Andrew Sinclair, Biopharm Services
In our video, Andrew Sinclair of Biopharm Services explains how cost modelling successfully predicted that the adoption of single-use technologies by the industry would reduce biomanufacturing costs. Watch it now.
March 12-14, 2017 – Qingdao, China: 14th CACLP (Intl.) Spring Expo
Established in 1991, CACLP (China Association of Clinical Laboratory Practice) Expo is now the most important trade show that focused on clinical laboratory and In-vitro diagnostics. The Expo offers a great platform for IVD companies from both China and abroad to exchange knowledge and ideas. Visit the team of Sartorius China at booth H4 B037.
March 14, 15 & 17, 2017: Sartorius Stedim India Biopharma Forum 2017
Don't miss our India Biopharma Forum 2017: From Cell Line to Manufacturing. This forum will provide insight to emerging trends that address current process development and commercial manufacturing challenges in upstream and downstream processes. Register now for one of our three events in Bangalore, Hyderabad and Mumbai.
March 7-8, 2017 – Reston, VA, USA: ISPE Aseptic Conference
This year's ISPE Aseptic Conference will again summarize innovative and best practices successfully employed to meet the growing complexities for aseptic processing without losing focus on classic Aseptic and Barrier applications. Visit Sartorius at the event to know more about our fully integrated upstream platform and further bioprocessing solutions.
February 27 - March 2, 2017 – North Bethesda, MD, USA: IFPAC Annual Meeting 2017
The IFPAC Annual Meeting is a forum for insightful discussions and knowledge transfer in the fields of Quality by Design, Process Analytical Technology, Quality Metrics, Continuous Manufacturing and Process Control applications. Meet us there to learn all about our innovative upstream solutions.
February 27 - March 2, 2017 – San Francisco, CA, USA: BioProcess International West
At the BioProcess International West, attendees can collectively share challenges of early stage process development and discuss the solutions needed to improve the speed, cost and quality. Don't miss our presentation on "Fast Track to Your QbD Approach - Integrated Bioreactor, Sensor & Software Platform to Accelerate Antibody Development" (February 28, 12:30 pm). And meet our team at booth 400 to find out how we can help your business.
Video: Virus Filtration by Franz Nothelfer, Boehringer Ingelheim Pharma
At the European Upstream & Downstream Forum 2016, Franz Nothelfer of Boehringer Ingelheim explained why growth media filtration with a virus-retentive filter could become the only risk-mitigation method accepted by the regulatory authorities.
Research Xchange Forum: Trends and Challenges in Oncology
Participate in our Research Xchange Forum in Goettingen, Germany, on February 22-23, 2017, to update your knowledge in cancer research and treatments. Keynote lectures from internationally renowned academics and leading biopharma R&D executives as well as inspiring discussions, demo sessions and many more highlights await you. #rxf17
Perfusion Cell Culture Processes: WuXi’s Experience from China
Dr Weichang Zhou (Senior Vice President, Biologics Development and Manufacturing) described WuXi Biologics’ approach to continuous bioprocess at Sartorius Stedim Biotech’s ‘China Bioprocess and Integrated Solution Innovation Forum’ held in September, 2016. Read this interview with Dr Zhou in which he discusses how intensified bioprocesses are increasing productivity in the biopharmaceutical industry:
Video: Quality by Design by Prof. José Menezes, 4Tune Engineering
Prof. José Menezes, 4Tune Engineering, believes the biopharma industry can help ensure patient safety using a Quality by Design approach that selects and aggregates the right PAT tools and then performs a multivariate data analysis (MVDA) on the acquired data. Watch our video from the European Upstream & Downstream Forum 2016 to hear more.
BPI Article: Continuous Cell Culture Operation at 2,000-L Scale
New technologies can help deliver upstream bioprocesses with higher productivities at preclinical, clinical, and commercial manufacturing scales. In this BPI article, the authors present data from a client showing the BIOSTAT® STR single-use bioreactor to be highly effective for performing continuous cell cultures at the 2000-L scale.
Supporting Mainstream Adoption of Quality by Design
Our fully integrated upstream platform enables customers to adopt a unique Quality by Design (QbD) approach. Combining the power of high-throughput mini bioreactors with data analysis and knowledge management tools allows biopharmaceutical companies to build quality into their products and to scale up robust and well-characterized processes at the first attempt. Read this B3C newswire article to learn more.
Video: Speed to Clinic by Dr. Jincai Li, WuXi Biologics
In our video from the European Upstream & Downstream Forum 2016, Jincai Li of WuXi Biologics highlights how the ambr® 15 high-throughput microbioreactor system can accelerate process development. Watch it here.
February 22-23, 2017 – Goettingen, Germany: Research Xchange Forum
Attend our Research Xchange Forum to learn more about the latest developments in cancer research and to establish collaborations with like-minded companies and academics. Check out the highlighted oncology topics and the speaker line-up on our event website and register today.
KNect365 Bioprocessing: Intensifying Biopharmaceutical Production
Companies need increasingly efficient manufacturing processes to reduce their cost of goods. Such improved efficiency must come without a detrimental effect of product quality, which is under ever-greater scrutiny. Read this KNect365 Bioprocessing article to learn how developing intensified processes can help companies to deal with current industry challenges.
BioProcess International: Reducing Upstream Processing Scale-Up Risks Using QbD
Companies seeking to develop manufacturing processes for new biopharmaceutical drugs face a number of challenges. Read this BPI article to learn how these complex challenges during scale-up can be addressed in the shortest possible timeframe and at reasonable effort and cost.
Webinar Feb 15: Strategies to Increase the Titers in CHO Cell Cultures
Register for our free webinar on February 15, 2017, to learn how to increase your titers by developing your own optimized medium and feeds in 5 months. Our media experts will describe our innovative approach based on the ambr® 15, an integrated DoE approach for efficient testing of different media mixtures, spent media analysis and on-site expert support.
Pharmaceutical Online: Expansion of Sartorius Stedim Cellca
Sartorius Stedim Cellca, based near Ulm in southern Germany, continues on the growth track. The company purchased property of more than 6,000 square meters at Ulm’s Science Park III at Eselsberg to build a new laboratory and office complex. Read the entire Pharmaceutical Online article here:
Webinar on Stable Cell Lines: Available on Demand Now
Don't worry if you missed our recent webinar "Developing Stable Cell Lines with an Orthogonal Approach to Analytics". It is now available for you. Watch it for free.
BPI: Virus Risk Mitigation in Cell Culture Media
The contamination of bioreactors with various infective agents such as viruses, bacteria, and mycoplasma is a potential risk to patient safety. Read this BioPharm International article to learn more about the impact of a contamination and about the demand for a new viral clearance concept in upstream processing.
Sartorius Collaborates with Synpromics to Reduce Timelines and Increase CHO Cell Line Stability
Sartorius Stedim Cellca and Synpromics collaborate to develop an improved biologicals manufacturing process using synthetic promoters. “We believe [this project] will offer significant benefit to our clients in being able to provide a superior production system for biological products”, says Dr Christoph Zehe, Head of Technology Development of Cellca.
Interview: Monoclonal Antibody Platform Processes
Nick Hutchinson, Technical Content Marketing Manager at Sartorius Stedim Biotech, talked to Dr Piranavan Thillaivinayagalingam, Director of Project Management from Alvotech Germany, about the industry’s current approach to manufacturing mAbs with platform processes. Read the interview here.
Research Xchange Forum: Last Call for Early Bird Registration
Join our Research Xchange Forum on February 22 & 23, 2017 to get insights into the latest developments in oncology from renowned international industry and academic speakers. The early bird discount for our forum expires on December 15, 2016. So hurry up and register now!
How to Meet Current Challenges of the Biopharmaceutical Market
In this BioProcess International article, our Senior Vice President of Marketing & Product Management, Stefan Schlack, shares his analysis of current industry trends and offers solutions to the challenges that biomanufacturers face.
BioProcess International: Superior Scalability of Single-Use Bioreactors
Read this BPI article to learn how the classical stirred-tank design of the ambr® 250, UniVessel® SU and BIOSTAT STR® bioreactors facilitates seamless scale-up using well established engineering principles while ensuring that product quality attributes are always achieved.
GEN Tutorial: Enabling Viral Vaccine Production
Single-use process platforms are helping biopharma companies to reduce both the time taken for new drugs to reach the clinic and process development costs. This GEN tutorial describes how manufacturers of Adenovirus vectors can use one such platform straight-from-the-box and with minimal optimization.
How to Implement QbD Efficiently and at Low Costs
In this video, Christel Fenge, Vice President of Marketing & Product Management for Fermentation Technologies at Sartorius Stedim Biotech, explains how our ambr® 250 minibioreactors allow you to quickly establish your design space.
GEN: Eyes on the Process Analytics Prize
In this article, Dan Kopec from Sartorius Stedim Biotech and other bioprocessing specialists discuss how to cope with increasingly complex cell culture media and protocols. Learn more about new ways to optimize feed additions to fed-batch cultures.
CHOptimizer®: Designed for Performance and Flexibility
The CHOptimizer® Media Builder service combines a modern, high-throughput approach with traditional ideas to deliver an optimized medium in a short timeline. It also includes field support and offers full access to the specific formula to ensure the ultimate in flexibility for the future. Learn more about how you will benefit from fully optimized media.
February 22 & 23, 2017: Research Xchange Forum in Goettingen, Germany
Learn all about current trends and challenges in oncology and exchange ideas as to their translation into viable solutions. Our Research Xchange Forum provides keynote lectures from internationally renowned academics and leading biopharma R&D executives, addressing the latest developments in cancer research and treatments. Register now!
The Medicine Maker: "Bioprocess Knowledge Is Power"
On the one hand, outsourcing can be an effective way to access indepth bioprocessing expertise. On the other, leaning on external resources can restrict internal learning. This article by the Medicine Maker is searching for a way to get the best of both worlds.
Comprehensive Catalog: Your Guide to Upstream Processing Solutions
Download our new upstream catalog and discover our solutions for your upstream processing needs. You will obtain a detailed overview of our cell line development services, media, bioreactors and fermenters, clarification solutions, analytics and engineering services.
Webinars Nov 15|17: Leak Test Your Bags at Your Point-of-use
Join our free webinars on November 15 or 17, 2016, to discover the new FlexAct® BT, a highly sensitive point-of-use bag tester capable of detecting 30µm pinholes on single-use systems. The sensitivity, reproducibility and accuracy of the tester and the relevance of the detection limit to the required level of integrity will be presented.
November 10,2016: Sartorius Upstream Day in Grimbergen, Belgium
Attend the Sartorius Upstream Days to gain valuable insights into our innovative upstream technology. Register now for our event in Grimbergen, Belgium, on November 10, 2016.
in-Pharma Technologist: "Pfizer on CMOs: $180bn Is at Stake so Being First-to-market Is Critical"
Discussing the evolving third-party manufacturing landscape at the CPhI Worldwide preconnect conference, Peter Stevenson – VP and general manager for contract manufacturing at pharma giant Pfizer – said the speed to market is crucial for drug developers. Read his statements in this in-PharmaTechnologist-article.
November 8, 2016: Sartorius Upstream Day in Evry, France
Discover our unprecedented upstream technology platform at the Sartorius Upstream Day in Evry, France. On November 8, 2016, we will present our high performance benchtop bioreactor ambr® 250 modular and other innovative equipment. Find out more and register here:
Webinars Nov 8|9: Flexsafe® Takes Your Facility into the Future
Our Flexsafe® bags are suitable for all your process steps, from media to final drug products. Register for our webinar on November 8 or 9. Learn how Flexsafe® bags are qualified with the most extensive regimes to provide the safest and most convenient storage and shipping solution.
Poster: CHOptimizer® – The Media Builder
Learn how to increase the productivity of upstream processes and achieve higher titers. This poster on the CHOptimizer® outlines a unique rapid approach for media and feed optimization in ambr® 15 bioreactors. The authors demonstrate that a 4-fold improvement in product titer from a fed-batch CHO process is achievable in less than 6 months.
November 3, 2016: Sartorius Upstream Day in Lyon, France
On November 3, 2016, Sartorius Stedim Biotech invites you to the presentation and demonstration of the ambr® 15 robot with CHOptimizer® blends, the ambr® 250 modular robot and the fill-it system. Check out the agenda and register now for the event in Lyon, France.
Process Development Roadshow - Royston, Great Britain
Attend the Sartorius Stedim Biotech Process Development Roadshow to gain valuable insights into the first fully integrated upstream platform on the market. Our final roadshow stop will take place in Royston, Great Britain, on November 18, 2016. Find out more and register here:
Flexsafe® Bags: Excellent Cell Growth and Lot-to-Lot Consistency
Sartorius has developed a polyethylene film and bioprocessing bags to facilitate the way towards the single-use facility of the future. Flexsafe® meets the most stringent needs for safer bioprocessing.
High-Throughput Bioprocess Development
This bioprocessing tutorial, published by Merck, explains how process development scientists can use the ambr® 250 automated minibioreactor system to screen a wide process design space, while minimizing resources and materials.
Inside BioPharma: Ready-to-Use PAT Solutions
What is the current state of PAT in the biopharma industry? What key challenges still remain? Take a closer look at biopharmaceutical equipment and processes with Sartorius Field Marketing Manager for Process Analytics in North America, Dan Kopec.
Impressions from the "China Innovative Forum of Bioprocess Integrated Solutions"
From September 1-2, 2016, Sartorius China hosted the China Innovative Forum of Bioprocess Integrated Solution in Suzhou. Watch this video to get an insight of the inspiring atmosphere of this event.
US Upstream & Downstream Technology Forum 2016 in Maryland, USA
Join our Upstream & Downstream Technology Forum at the University of Maryland on October 26, 2016. The event continues to build the collaborative bridge between upstream and downstream bioprocessing. Meet specialists from your peer group who will present best practices, applications and techniques to address the bottlenecks at the interfaces of upstream and downstream.
BioPharm Reporter: Cut Development Times with Upstream Suite
Time to clinic is particularly important, according to Miriam Monge, Sartorius Stedim's director of integrated solutions: "Due to growing pipelines, efficiencies must be gained in process development [but] in the past cell line and process development has been slow and labour-intensive." Read this BioPharm Reporter article to learn how Sartorius' upstream platform helps biopharma companies carve months off the development time for new products.
Webinar: New PD Workflow for Short Timelines and Rapid Scale-Up
In this live webinar on October 20, Dr. Jincai Li, Executive Director at WuXi Biologics, will discuss how their new process development workflow delivers accurate clone selection, powerful DOE optimisation and scale-up tools, improving predictions and reducing timelines. Register here for the one hour webinar:
Sartorius Stedim Biotech at BPI Conference & Exhibition 2016 in Boston
Let's meet up at the BioProcess International Conference & Exhibition in Boston, USA, from October 4-7, 2016. Discover our fully integrated upstream platform and latest technologies and services. Experience our product demonstrations, showcases, videos and posters. We're looking forward to welcoming you. Booth 929.
Don't Miss our Presentations and Workshops at BPI Conference & Exhibition 2016
From October 4-7, we share our knowledge with you at the BioProcess International Conference & Exhibition in Boston. Take your chance to meet our bioprocess experts and discuss the latest advances in cell culture media and feed optimization, automated single-use bioreactor systems and process analytical technologies.
Upstream and Downstream Processing: One Common Goal
For more than 10 years, the Upstream & Downstream Technology Forum has proved to be an exciting venue for presentations, networking and discussions focusing on the latest applications and technologies in the biotech industry. Watch this video to learn about the most important topics of this year's forum which took place in Goettingen, Germany, on June 7-9, 2016.
ambr®-based Technology amongst Upstream Award Finalists
Glycotope, a global leader in Glycobiology, is nominated for the Best Technology Application - Upstream Award by BioProcess International. The nominated "Sedimentation in an Automated Microbioreactor" (SAM) model uses Sartorius' ambr®15 systems. Find out more about the short and long term benefits of the ambr®-based technology.
Biopharmaceutical Quality Optimization
Which challenges does the industry face when implementing continuous bioprocesses? And how can they be addressed with process analytical technologies (PAT)? In this article, these and other topics are discussed by Stuart Tindal and Nick Hutchinson of Sartorius Stedim Biotech.
BioPharm International on Sartorius' Integrated Upstream Platform
Sartorius' platform can help biomanufacturers cut development timelines, with products reaching the clinical phase within 14 months. BioPharm International describes in its article how the platform enables rapid development and scale-up of robust titers by combining a CHO expression system with outstanding equipment and process controls.
GEN: Beware of Obstructions in the Upstream Processing of Biologics
With fewer failures and better tools for monitoring culture parameters, companies are able to eliminate unsatisfactory candidates early on, and move their best molecules forward rapidly. In this GEN Magazine column, Dr. Christel Fenge, Sartorius Stedim's vice president of marketing for fermentation technologies, and other experts discuss how new upstream innovations hasten product development.
Move Out of Your Comfort Zone and Push the Limits of Productivity
In 2004, the U.S. Food and Drug Administration issued an official guidance on process analytic technology (PAT), to encourage its voluntary adoption as a means of achieving quality by design (QbD). Find out how PAT tools increase consistency and process robustness.
Sartorius Stedim Biotech Presents the First Fully Integrated Upstream Platform
To meet the requirements of today’s upstream bioprocessing, Sartorius Stedim Biotech developed an innovative and fully integrated technology platform. Read about how the unique product and service portfolio covers all steps from cell line development to commercial manufacturing processes.
Improving Product Quality by Understanding Bioreactor Conditions
Conditions within the bioreactor can heavily influence the quality of biopharmaceutical products. In his new blog entry, Sartorius Stedim Biotech Content Marketing Manager Dr. Nick Hutchinson explains how a DOE approach allows scientists to identify interactions between process variables.
Sartorius uniQure Site Tour at BPI Conference & Exhibition 2016
During BioProcess International Conference & Exhibition, Sartorius will be hosting a site tour to the uniQure Facility in Lexington, MA, on Tuesday, October 4th. uniQure is a leading fully integrated gene therapy company and manufacturer of the first EU approved gene therapy product Glybera. Secure your space on the tour now!
Adopting a Platform Approach to Upstream Processing Increases the Speed to Clinic
Read our white paper to learn how companies can save around 3-6 months of development time by the adoption of a platform approach to cell line development. The Cellca CHO expression platform and development services allow companies to move from DNA to having a research cell bank and cell culture process much more quickly.
Integrating Single-Use Systems in Biopharma Manufacturing
In this article, industry experts discuss the challenges of using single-use systems in biopharma manufacturing. Read the advice from Miriam Monge, Director of Process Development & Bioprocess Platforms at Sartorius Stedim Biotech, and other professionals.
Accelerating Biopharmaceutical Development from DNA to Drug
This white paper by Floris De Smet, Juan Pablo Acosta-Martinez, Nick Hutchinson, Christel Fenge and Miriam Monge explains how taking a holistic approach right from early process development stages can speed up time to clinic and ensure efficient process transfers.
Meet Us at BioProcess International Conference & Exhibition in Boston
With more than 1,800 attending bioprocessing professionals and over 225 top-level speakers, BioProcess International Conference & Exhibition is the largest bioprocessing event. Meet us there from October 4-7, 2016, to discuss the latest advances in cell culture media, feed optimization, automated single-use bioreactor systems and process analytical technologies. Boston Convention and Exhibition Center, booth #929.
Reducing Timelines in Early Process Development
In this article, Cobra Biologics outlines a novel, multi-parametric approach for clone selection and feed-strategy optimization. Conducting the studies in this way took just four weeks, whereas the equivalent work in bench-top bioreactors would have required several weeks more.
China Bioprocess and Integrated Solution Innovative Forum
Broaden your process understanding and update your knowledge in upstream and downstream processing while meeting experts from the industry. We look forward to meeting you at the China Bioprocess and Integrated Solution Innovative Forum in Suzhou, on September 1-2, 2016.
5 Tips for Accelerating Upstream Process Development
The enormous financial implications of reaching the market quickly mean that biologics manufacturers must achieve their objectives in the shortest possible time. The new blog post by Dr. Nick Hutchinson, Content Marketing Manager at Sartorius, offers 5 useful tips on how to achieve this.
Is ADCC the Biggest Challenge to Your Biosimilar?
Avoid costly pitfalls during the development of your biosimilar by accurately determining ADCC activity. Our video will show you how ADCC assays from BioOutsource can help unpick the issues of similarity between innovator and biosimilar drugs.
Shortening Timelines for Upstream Bioprocessing of Protein-based Therapeutics
Read this case study, published by Wuxi AppTec, to learn how the company shortened the time for upstream process development from 22 to 16 weeks by replacing traditional shake flasks and bench-top bioreactors with a combination of automated micro and mini bioreactor systems.
RCB in Just 4 Months With the Cellca CHO Expression Platform
Reduce timelines in early process development: The Cellca royalty-free CHO expression platform is an easily accessible, scalable and robust system that takes your product from DNA to RCB in just 4 months. It is designed to reduce cost of goods, development risks and ultimately reduce development time.
BioTech 2016 Sponsored by Sartorius Stedim Biotech
We are excited to be event sponsor of BioTech 2016 organized by ZHAW. Join us at Wädenswil, Switzerland, on September 5 and 6. Our presentations, keynote lectures and workshops will update you on the latest developments in the field of biopharmaceutical manufacturing and single-use technology.
New Released N-Glycan Assay
Sartorius Stedim BioOutsource announced the launch of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay combines data on the molecular structure with a key therapeutic mechanism of action.
Register for Our FlexAct® BT Discovery Day in Dublin
Join us at the world-renowned NIBRT Institute in Dublin on September 14, 2016, to see how FlexAct® BT can improve single-use container closure integrity within your process. Register now and take advantage of this free-to-attend event.
Interview: The Early Stage Development of Biopharmaceuticals
Our Technical Content Marketing Manager Dr. Nick Hutchinson interviewed Dr. Will Lewis of GSK exploring the issues relating to the early stage development of biopharmaceuticals. A central theme was the need for a holistic approach in which upstream and downstream development become "one-stream".
Facilities of the Future: What to Expect
At BioProcess International European Summit in Vienna on 12 - 13 April 2016, four leading figures were asked what they see as the progression of today’s facilities. Watch Daniel Galbraith, CSO at Sartorius Stedim BioOutsource, describe bioprocessing facilities of the future.
SSB Expands Bioprocessing Product Portfolio With Innovative Single-use Centrifuges
Sartorius Stedim Biotech has signed a contract to acquire U.S. centrifuge specialist kSep Holdings, Inc. The privately owned company based in Morrisville, North Carolina, has developed and markets single-use, fully automated centrifugation systems used for manufacturing biopharmaceuticals.
The Industry Standard Bioreactor for Advanced Process Optimization and Characterization
Our new high-end benchtop bioreactor BIOSTAT® B-DCU is specifically designed to accommodate the broad requirements of process optimization and characterization. Benefit from its advanced sensor and software integration, a broad range of process control strategies and reliable industry standard technologies.
Update: Advanced Bioprocess Monitoring with BioPAT® MFCS 4.2
The SCADA system BioPAT® MFCS is a centralized data management software for non-GMP purposes. BioPAT® MFCS 4.2 provides two new optional modules, which complement the remote bioprocess monitoring capabilities: A Charting Module for advanced data visualization and inspection and a Calculation Module for on-line and off-line calculation of bioprocess parameters.
Single-Use Systems Testing Directly After Pre-Concept Phase
As soon as single-use technology selection has been made, our project teams will help you evaluate the extractable data package for film and components. Learn more about our six-step process from conceptual design to final on-site acceptance.
Sartorius Application Center: Your Space to Get to Know Our Solutions
Our Application Center is located in China (Shanghai), Germany (Goettingen) and the United States (New York). It provides you with the opportunity to test-run our state-of-the-art systems for upstream processing applications and other cutting-edge equipment. Get more information.
The Cellca CHO Expression Platform: Preparing for Future Bioprocessing Challenges
Dr. Brian Wendelburg, Sr. Field Marketing Manager for BioOutsource and Cellca at Sartorius Stedim Biotech, published a guest post on the blog "Future of BioParma". It reflects on "Preparing for Future Bioprocessing Challenges With the Cellca CHO Expression Platform". Read it now.
Webinar: New Single-Use Benchtop Bioreactor for Scalable Process Development
Join us for our live launch webinar on Tuesday 19 July to find out more about the new ambr® 250 modular system. Once registered, you will also receive an on-demand link which you can watch later or share with your colleagues.
Article: Implementing Flexible, Cost-Efficient Bioprocess Platforms
In this BPI article, Thorsten Peuker (Vice President, Integrated Solutions, Sartorius Stedim Biotech) and Miriam Monge (Director of Marketing, Integrated Solutions, Sartorius Stedim Biotech) provide an overview of the project management methodology and the supportive tools that the Sartorius Integrated Solutions team applies to ensure reduced timelines, high flexibility, strong supply chain security and minimal COGs (cost of goods) for your process.
Run More Development Projects in Parallel
Speed up process development and gain process understanding early on: Learn how our process development consultants can support you, right from early phase development through scale-up to commercial manufacturing.
Application Report: Effect of Flux Decay on Virus Retention
This application note describes virus retention properties of Virosart® CPV, the Sartorius 20 nm Polyethersulfone membrane virus filter. It outlines virus retention data for Virosart® CPV with increasing flux decay profiles for several different proteins.
Article: A Standardized Assay to Test Suitability of Single Use
Learn about industry best practices and standards for materials in single-use systems (SUS) components with this article from BioProcess International.
BioPAT® Toolbox for Upstream
Stuart Tindal, Product Manager at Sartorius Stedim Biotech, explains on LinkedIn, a professional social network, how the BioPAT® toolbox combines analytics and software from Sartorius Stedim Biotech. It gives you the current status, level of understanding and precise control of your process.
Whitepaper: Accelerate Your Process Development
"Are automated disposable small-scale reactors set to dominate the future of pharmaceutical bioprocess development?" – As the R&D climate for biologics and vaccines becomes more competitive and budgets are driven down, you must take advantage of technologies that allow for rapid process development and optimization...
Single-use Platforms Helping Democratize Biomanufacturing
This article examines key advances in single-use process platforms that are simplifying the implementation of biomanufacturing processes. The major benefit for drug developers is the reduced time to market, while increasing the product's safety and keeping its manufacturing costs minimal.
Virosart® HF: The Single-use Filter for MAb
Our ready-to-use filter Virosart® HF will eliminate costly sanitization and reduce your flushing volumes by 80%. Benefit from its gamma compatibility for easy implementation in a single-use mAb process.
New Sartorius Stedim BioOutsource Website Goes Live
Sartorius Stedim Biotech's subsidiary BioOutsource launched an updated website to spotlight Sartorius Stedim Cellca’s cell line and upstream process development services for the biopharmaceutical industry. To find out more about Cellca’s cell line and upstream process development services, scientists should click this link to the new website.
TAKEone® Aseptic Sampling System
The TAKEone® is a single-use, pre-assembled sampling device for aseptic collection of samples during upstream and downstream process steps. Watch our video to learn what makes TAKEone® a perfect fit for any sampling plan.
Highest virus safety for your patient
Virosart® virus filters provide stable virus retention without impact through pressure variations, high loads or process interruptions. Find the right virus filter for your application.
Single-use micro scale bioreactor enables higher productivity
Dr Barney Zoro, ambr® 15 Product Manager at Sartorius Stedim Biotech in Royston, UK, explains how automated micro and mini bioreactor models improve upstream cell culture productivity and reduce manufacturing COGs (cost of goods).
WuXi Biologics and Sartorius Stedim Biotech Open Joint Lab in Shanghai
Sartorius Stedim Biotech and WuXi Biologics today announced the opening of their Joint Laboratory in Shanghai, marking a new stage in their long-term cooperation. "WuXi Biologics is devoted to building the leading ONE-stop service platforms for biologics R&D and manufacture and to providing comprehensive services for biopharmaceutical clients throughout the world,” said Dr. Chris Chen, CEO of WuXi Biologics.
Choosing Between Perfusion and Batch Production
This special report in the May 2016 issue of BPI features an article from Christel Fenge, VP Marketing, Fermentation Technologies at Sartorius Stedim Biotech about continuous upstream bioprocessing (page 16).
Participate in this year’s Viral Safety event
This event is an interactive forum for biotech industry experts to specifically address the latest tools and strategies in virus safety. We are looking forward to welcoming you at our booth #9. We'd also like to invite you to our presentation on June 22, at 09:35 a.m.Get an exclusive 25% discount as a Sartorius Stedim Biotech customer:
High-density Fed Batch Microbial Screening
New data: microbioreactor ambr® 15 fermentation supports high-density fed-batch microbial screening #bioprocess. Get our free poster here: