Biosimilar App Notes & Case Studies

  1. How Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

    Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

  2. Automated Cell Bleed Control In An Intensified SU Rocking Motion Bioreactor 11/20/2019

    Intensified processing increases the productivity of single-use facilities and decreases the manufacturing footprint. Here's how to optimize the approach.

  3. A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale 9/28/2020

    As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

  4. Platform Cell and Gene Therapy Media Development 9/9/2020

    This article highlights a case study on the removal of serum from the expansion step of an autologous cell therapy in a cost-effective manner without affecting cell performance.

  5. 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. 

  6. Improving Lentiviral Vector Downstream Processing Workflows 8/5/2020

    Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

  7. 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.

  8. 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.

  9. Effectively Managing Data In Process Development 1/11/2021

    Addressing data management challenges during drug development requires an understanding of today’s shortcomings and the factors to consider when adopting a solution to overcome them.

  10. Practical Tips To Develop A Lentivirus Packaging Cell Line 9/9/2020

    CAR T therapies are expensive, and lentiviral vectors production represents a large portion of these costs. These practical tips guide efficient development of a lentivirus packaging cell line.