Biosimilar App Notes & Case Studies

1. Key Insights Into Overcoming mRNA Process Challenges 9/8/2021

   Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.

2. Alkaline Stability Of Fc And VH3 Binding In Protein A Resins 5/1/2023

   In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).

3. Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market 11/8/2021

   Understand the role training devices and patient education play with regard to self-injection therapies. Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

4. Enabling Bioprocess Control With Successful Automation Strategies 12/9/2021

   In a recent live event with Bioprocess Online, industry experts at various stages of their automation journey discussed their approach to enhancing quality control and data integrity through automated technologies.

5. AAV Full/Empty Capsid Separation Using Mechanistic Modeling 5/1/2023

   In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl₂ is used as an elution additive.

6. Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy 9/30/2022

   Learn more about the analytical development for mAbs and recombinant proteins

7. Maximize Product Recovery In Bulk Filtration And Filling Flow Paths 12/15/2022

   Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize non-recoverable hold-up within the filtration and distribution flow path sections.

8. Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier 8/23/2021

   Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

9. Streamlining The Integrity Testing Process – From Test To Report 2/22/2023

   Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

10. Optimizing Recovery On The Sepax™ Cell Processing System 7/21/2022

    Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.