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.
Director, Marketing Integrated Solutions
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 biosimilar testing services for monoclonal antibodies, providing more than 100 off-the-shelf assays for the fast characterization of a large variety of biosimilar antibodies.
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.
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.
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.
The foundation for approval of biosimilar molecules is built on a robust analytical data package that proves similarities between the reference product and the biosimilar molecule. The BioOutsource analytical testing package for biosimilars combines physicochemical and biological analysis for in-depth characterization and comparability from one contract partner. Enabling fast data-driven decisions during drug development with platform methods and off-the-shelf assays.
Characterize the binding and functional activity of your biosimilar molecule with a range of cell-based assays, binding and potency assays. A comprehensive range of assays are available off-the-shelf for over 12 biosimilar target molecules.
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.
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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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.
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.
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.
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.
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.