Biosimilar Development solution center

  1. Efficacy Screening Of Antibody-Drug-Conjugates By Surface Plasmon Resonance 6/3/2024

    Rapid screening of ADC affinity using surface plasmon resonance provides preliminary efficacy data in comparing antigen binding affinity with selected linkers and payloads to the non-conjugated antibody.

  2. Establishing Commercial Manufacturing Services For ADCs 6/3/2024

    Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

  3. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

  4. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  5. Viral Vector Producer Cell Lines: Learning From mAbs 5/7/2024

    Learn how applying bioprocessing knowledge from the production of mAbs can accelerate the development of viral vector cell lines and improve efficiency in gene therapy manufacturing.

  6. Tips For Viral Vector Production 4/16/2024

    Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

  7. 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies 4/9/2024

    Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.

  8. Top Challenges In Recombinant Protein Purification Process Development 3/27/2024

    Get insights from process developers working with recombinant proteins that cannot be purified with affinity chromatography.

  9. Three Key Considerations For Optimizing Process Development 3/25/2024

    When it comes to process development, timing, technology, and partners all merit careful consideration. Explore expert insights into these three crucial factors.

  10. Navigating Cell Therapy Process Development 3/25/2024

    Equip yourself with the knowledge necessary to make well-informed decisions by exploring the main challenges and considerations inherent in cell therapy process development.