Featured Bioprocessing Editorial

  1. Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity 2/23/2023

    Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.

  2. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.

  3. Trends In FDA FY2022 Inspection-based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.

  4. A Payday For Payloads: The Transactional Landscape Of ADCs 2/16/2023

    In the last five years, ADCs deals have netted some of the biggest payouts in oncology drug development. The transactions signal excitement for the evolving modality's long-term exclusivity potential and robust targeting capabilities.

  5. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  6. 2023’s Market Outlook For Cell And Gene Therapies 2/14/2023

    This article discusses quantifiable market trends, clinical developments, regulatory landscape analysis, and investment trends for cell and gene therapy companies in 2023.

  7. Using QbD Principles To Register Innovative Raw Materials 2/13/2023

    Control of biopharmaceutical raw materials is defined by the license holder. We propose a best practice approach to registering innovative and complex raw materials based on quality by design (QbD) principles. It can be applied to different families of non-compendial raw materials used when manufacturing biologics.

  8. Examining Protein Domains For Targeted Biologic Drug Delivery 2/10/2023

    The use of individual protein domains that have been well characterized to create hybrid proteins with desired combinations of biochemical properties is a promising new approach to biologic pharmaceutical agents. I share recent work with regard to the parathyroid hormone, which has important roles in regulation of calcium and bone.

  9. 4 Focus Areas To Expand The Success Of Antibody-Drug Conjugates 2/9/2023

    Antibody-drug conjugates (ADCs) represent a significant advance in therapeutic engineering. They combine an antibody, a linker, and a payload designed into a single molecule for delivery to a specific target. Why do discontinuation rates remain high, and what are the novel strategies that we as drug developers can use to maximize success?

  10. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.