Biosimilar App Notes & Case Studies

  1. Generating A Robust Host Cell Line For A Cell Line Development Platform 11/14/2022

    Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.

  2. Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges 7/21/2023

    Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing can could solve three of these key challenges regarding instrumentation.

  3. Apheresis Variability Control In Cell Therapy Manufacturing 7/25/2022

    Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.

  4. Biacore™ SPR Systems For Titer Analysis Of Adeno-Associated Virus 10/13/2022

    We describe the performance of two assays for titer analysis of adeno-associated virus (AAV), serotype 2 and serotype 5, based on surface plasmon resonance (SPR).

  5. Natural Killer Cells Manufacturing 7/22/2022

    Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.

  6. Outsourcing Process Dev: Key Considerations For Biopharma 3/14/2022

    In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

  7. Transition To Closed Processing Systems 10/12/2022

    Learn about one facility's transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.

  8. How To Ensure Correct Component Selection When Outsourcing To A CMO 3/22/2023

    A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

  9. Determining RNA Integrity And Purity By Capillary Gel Electrophoresis 6/30/2023

    To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

  10. In-House Manufacturing: Key To Driving A Diabetes Vaccine? 1/28/2022

    Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.