Biosimilar App Notes & Case Studies

1. 6 Reasons You Don’t Use Pharmaceutical Market Research 2/28/2020

   If you're using one of these six excuses for ignoring pharma market research, you're failing to understand barriers to success, missing the market’s perspective, and leaving assumptions unvalidated.

2. Optimizing Cell Culture Media: Increase Titer With Maintained Protein Quality 2/21/2020

   When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.

3. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

   Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

4. Low-Risk Approach For Process Transfer From Development To Manufacturing 8/17/2020

   This paper explores one approach for overcoming several scale-up issues with the use miniature bioreactors for process development.

5. Lessons Learned Executing A Closed Connected Processing From Start To Finish 12/22/2020

   Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.

6. Epitope Binning: A Critical Step In Antibody Selection 1/31/2020

   Epitope binning immunoassays using surface plasmon resonance (SPR) can and should be deployed in the development of new potential drug candidates. This article discusses how SPR is used to characterize closely related “bins” of mAbs targeting the same epitope of the target protein and how the selection process is used to develop new vaccines, therapeutic antibodies, and diagnostic tools.

7. Developing A Continuous Large-Scale Perfusion Cell Culture Process 9/25/2020

   The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality. 

8. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

   Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

9. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures 2/21/2020

   This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.

10. Modular Bioprocessing Alleviates Drug Manufacturing Woes 4/4/2019

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.