Bioprocessing White Papers

  1. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  2. Small Volume ATMP Cryo-Freezing Strategies 3/11/2025

    Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

  3. ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing 3/11/2025

    Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.

  4. Computational Fluid Dynamic Characterization Of Vertical-Wheel Bioreactors 3/6/2025

    Explore how computational fluid dynamics (CFD) characterize and scale-up vertical-wheel bioreactors, optimizing hydrodynamic conditions for effective induced pluripotent stem cell (iPSC) culture.

  5. Achieving Rapid, High-Titer Expression For Next-Generation Biologics 3/5/2025

    This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

  6. Cell Culture Process Scale-Up Challenges For Commercial-Scale PSC Manufacturing 3/5/2025

    Allogeneic cell therapies offer incredible promise, but scaling up PSC manufacturing presents unique challenges. Explore these hurdles along with solutions for consistent, high-quality production.

  7. Improving API Solubility 3/3/2025

    Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

  8. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  9. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  10. Supplier Quality And The True Cost Of Recalls 2/20/2025

    Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.