Cut early development times drastically

Connect Upstream for Speed to Clinic

Reach the clinic in 14 months and achieve high titers with the Cellca royalty-free CHO expression platform. Pick the best clones with ambr® 15 and scale up readily to our BIOSTAT STR® bioreactors. Off-the-shelf assays from BioOutsource allow rapid testing of your biosimilar product.

 

"With the Cellca CHO expression
platform and BioOutsource
analytics, early development
timelines can be cut drastically."

Miriam Monge,
Director, Marketing Integrated Solutions

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Cellca

Cellca

The Cellca royalty-free CHO expression platform is comprised of a host cell line originated from CHO DG44, with a vector constructed from well-known genetic elements, a cell culture media system and of process scale-up expertise.

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BioOutsource

A comprehensive suite of analytical services to support the testing of biologic drugs and vaccines throughout preclinical testing, manufacturing and lot release. In particular, BioOutsource specializes in testing services for innovator and biosimilar monoclonal antibodies, providing more than 100 off-the-shelf assays for the fast characterization of a large variety of mAb based therapeutics.

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ambr®

ambr® 15 cell culture mimics the characteristics of classical bioreactors at microscale (10-15mL) by using cost-effective, disposable micro bioreactors controlled by an automated workstation. The system enables the rapid evaluation of different clones at microscale, thereby increasing your speed to clinic.

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BIOSTAT STR® Bioreactors

The BIOSTAT STR® familiy consists of a range of completely single-use bioreactors with a conventional stirred-tank bioreactor design that is ideal for high-density cell culture applications. The range has true scalability from process development to pilot to production scales, minimizing both the effort associated with scaling up cell culture processes and the risk of process transfer even to larger-scale bioreactors.

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RCB in Just 4 Months

Reduce your early stage development timeline by several months with the Cellca CHO expression platform, accelerating your development from DNA to Research Cell Bank (RCB) to just 4 months with an easy-to-use, robust and scalable platform.

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Latest Upstream Innovations:

Total Characterization Testing Services for Biologics

The foundation for approval of novel biological entities and biosimilar drugs is built on a robust analytical data package that proves the safety, purity and potency of the product. The BioOutsource analytical testing package combines physicochemical and biological analysis for in-depth characterization and comparability studies from one contract partner. Available from pre-clinical through clinical phases and lot release. Enabling fast data-driven decisions during drug development with platform methods, off-the-shelf assays and custom bioassay development.

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Speed to Clinic – Reach the clinical phase in 14 months

Biological Analysis

Characterize the binding and functional activity of your biologic molecule with a range of cell-based assays, binding and potency assays. Advance the development of your biosimilar with our comprehensive range of assays,  available off-the-shelf for over 12 biosimilar target molecules.

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Speed to Clinic – Reach the clinical phase in 14 months

Physicochemical Analysis

Characterize the structure and physicochemical properties of monoclonal antibodies during drug development with a comprehensive range of methods to characterize protein structure, carbohydrate profile, post-translational modifications and impurities. Our state-of-the-art techniques follow ICH Q6B regulatory guidelines to enable an efficient, streamlined development process.

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Establishing a Master Cell Bank from top producing cell lines has never been faster or easier

Sartorius Stedim Biotech has combined the high throughput screening capabilities of the ambr® 15 system, the simultaneous IgG titer and cell viability analysis of Cy-clone™ PLUS for determining “Top 3” cell line clones, and the GMP Master Cell Banking (MCB) services from BioOutsource. This integrated offering generates MCBs from cell lines that will perform best in production, due to ability of the ambr® 15 to predict large-scale bioreactor performance. By engaging with a single supplier, you can benefit from our automated high-throughput tools providing you with high producing, stable and GMP-compliant MCBs in less time and with less effort.

More about ambr® 15

More about Cy-Clone PLUS

More about BioOutsource Cell Bank Manufacturing

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Speed to Clinic – Reach the clinical phase in 14 months

ambr®

ambr® 15 cell culture mimics the characteristics of classical bioreactors at microscale (10-15mL) by using cost-effective, disposable micro bioreactors controlled by an automated workstation. The system enables the rapid evaluation of different clones at microscale, thereby increasing your speed to clinic.

More about ambr®

Speed to Clinic – Reach the clinical phase in 14 months

Quickly Rank Cell Line Clones with More Relevant Data from a Single Assay

Cy-Clone PLUS is the only solution that correlates IgG quantitation per cell with cell viability readouts and cell density in a single, cost-effective assay that can migrate through your workflow from screening to scale up. Now, you can make the best decisions earlier in the process as well as every step of the way.

More about Cy-Clone Plus

Speed to Clinic – Reach the clinical phase in 14 months

GMP Master and Working Cell Bank Manufacturing

To ensure safety and quality of any biological product, it is essential to have a fully characterized, well-documented master cell bank (MCB) and working cell bank (WCB). Utilizing BioOutsource’s CRO expertise, our highly experienced team have expanded our service offering to include cell bank manufacturing. Cell banks are manufactured in a closed production system with in-line monitoring and control allowing the generation of 500 vial cell banks. All critical process steps conducted within a Bioquell isolator including automated high-throughput vial filling to reduce contamination risks.

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Free Webinar Speed to Clinic

Learn how to accelerate your development from DNA to clinic with an easy-to-use, robust and scalable upstream platform. Sartorius Stedim Biotech’s Speed-to-Clinic webinar is available for you to view on-demand – for free.

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Would you like to receive regular news about industry trends and Sartorius innovations?
Shortening Timelines for Upstream Bioprocessing of Protein-based Therapeutics

Shortening Timelines for Upstream Bioprocessing of Protein-based Therapeutics

Jincai Li (2015) Biopharm Asia Nov./Dec. 2015

This case study, published by Wuxi AppTec, explains 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.

Automating development activities allowed the company to reduce the resources required to define a cell culture process. Data from the resultant process showed excellent comparability between the ambr® 15 micro bioreactor and a 200 L BIOSTAT STR® single-use bioreactor.

Download article from BioPharma Asia

Reducing Timelines in Early Process Development – Using a Multiparametric Clone-Selection and Feed-Optimization Strategy

Reducing Timelines in Early Process Development

Ingrid Lange, Sunil Chhatre & Barney Zoro (2014) BPI Nov 2014.

Cobra Biologics outlines a novel, multi-parametric approach for clone selection and feed-strategy optimization in this article. Conducting the studies in this way took just four weeks, whereas the equivalent work in bench-top bioreactors would have required several weeks more.

The company successfully verified the process with the clone selected by the multi-parametric approach in 5 L bench-top and 250 L pilot-scale bioreactors. The platform reduced timelines and costs in early-stage upstream process development.

Read article from BioProcess International

White Paper: Adopting a Platform Approach to Upstream Processing Increases the Speed to Clinic of New Biopharmaceuticals

Adopting a Platform Approach to Upstream Processing Increases the Speed to Clinic of New Biopharmaceuticals

By Hugo DeWitt, Mitch Scanlan, Tim Ward and Christel Fenge (Sept. 2016)

One of the first steps in the journey of a product to the clinic is the development of a cell line for its expression. 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.

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Contact

Fast-track your upstream process development. We’ll help you reach the clinical phase in as little time as possible. Let us know your questions and requests. You will hear from us shortly.

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Speed to Clinic by
Dr. Jincai Li, WuXi Biologics,
at the European Upstream & Downstream Forum 2016

Reaching the clinical phase as quickly as possible directly affects the return on investment (ROI) made by biopharma companies. Jincai Li of WuXi Biologics describes how the ambr® 15 high-throughput microbioreactor system can accelerate process development by enabling a better clone selection program and a subsequent rapid scale-up to 2000L bioreactors.

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