Biosimilar App Notes & Case Studies

1. AAV Production Using Microcarriers 6/2/2021

   Scientists have successfully adapted an adherent HEK293 cell line to grow in animal component-free and serum-free suspension conditions in shaker flasks. After comparing adherent, suspension, and microcarrier culture for AAV production, they believe that microcarrier culture is suitable for large-scale production of viral vectors to support future gene therapy manufacturing processes.

2. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

   See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

3. Virus Retention Performance Of Viresolve® Pro Devices Under A Range Of Processing Conditions 8/12/2021

   Virus filtration is a critical operation in many biologic production processes and a key component of most viral safety strategies. Viresolve® Pro devices are released to a specification that provides at least 4.0 logs of small virus, such as parvovirus, removal. This document provides information on virus retention performance of Viresolve® Pro devices and is framed in the context of a process design space within which the filters would be expected to operate.

4. Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio 3/12/2021

   Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.

5. Introducing N-1 Perfusion To Intensify The Seed Train At A Higher Starting Density 5/13/2021

   A high-density N-1 seed culture can improve your fed-batch process by allowing you to seed the production (N) bioreactor at a higher starting density or to replace a large N-1 bioreactor.

6. Industry Trends In Clinical Development Technology 3/18/2020

   As electronic data sources become embedded in the clinical development process, systems, processes, files, storage, and approvals are moving away from paper and becoming application dependent.

7. N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit 6/7/2021

   A mid-to-large biopharma wanted to increase productivity 2-3× in their fed-batch facility and and also reduce their current cost of goods (COGS). With one small change in the upstream (USP) seed train, the customer was able to meet their goals.

8. Viral Vector Scale-Up: How Can We Bridge The Technology Gaps? 4/15/2021

   Unlocking the full potential of viral-vector based therapies requires an understanding of existing challenges in viral vector production and which technologies are now available in upstream and downstream processing to help address them.

9. Improving The Supply Of Single-Use Technologies 6/24/2021

   The use of single-use technologies has been growing steadily over the past decade, but there are challenges. Explore the potential solutions for single-use supply constraints.

10. Increased Productivity With Concentrated Fed-Batch 6/7/2021

    A large biopharma company wanted to establish a single-use multi-product facility by choosing appropriate upstream processes that can deliver more than 500 kg/year throughput. This case study shows how a concentrated fed-batch process was established, enabling higher productivity and increasing the throughput (up to 4× higher titer than standard fed-batch), providing more flexibility for production runs.