Biosimilar Development solution center

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 New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Formulation Process And Analytical Development Capabilities 3/25/2024

    Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.

  9. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  10. Building Biopharma Resilience In Developing Gene Therapies 3/21/2024

    Learn about the opportunities and challenges surrounding gene therapies, the importance of collaboration between biopharma startups and academia, difficulties with the talent pipeline, and more.