Biomanufacturing Featured Articles

  1. A Launchpad For Scalable Systems In AAV Gene Therapy Manufacturing 3/21/2024

    Identifying a trusted supplier that can address the myriad of challenges that accompany development for AAV-based drugs is critical to securing an asset’s ultimate commercial success.

  2. How To Prevent And Manage Temperature Excursions In Clinical Trials 3/20/2024

    Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.

  3. A New Model Approach To Drug Shortage Prevention 3/15/2024

    The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.

  4. Stressing Cells: The Role Of Cryoprotectants In ATMP Cryopreservation 3/7/2024

    Explore the challenges of adding cryoprotectants, how they can help reduce the effects of harmful conditions like ice crystals, and the need for future stability studies and substitutes for toxic CPAs.

  5. Insights Into GMP Manufacturing Of RNA-LNP Drug Products 2/29/2024

    Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

  6. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

  7. Risk And Supply Chain Continuity Management: Biologics Industry Perspectives 2/26/2024

    We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.

  8. A Step-By-Step Guide To Cell Banking 2/8/2024

    Cell banking stands at the forefront of medical advancement. This guide delves into the steps involved in protecting these priceless resources, from cell collection and processing to storage and cell expansion.

  9. Getting Genomic Medicines Ready For Prime Time 2/5/2024

    Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, and more.

  10. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.