Guest Columns

  1. A Checklist For Mechanism-Based Potency Testing In Cell Therapy 4/25/2025

    New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

  2. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

  3. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  4. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  5. Common Manufacturing Challenges For LBP Formulations 4/23/2025

    As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

  6. What CDMOs Wish Biotechs Knew Before Submitting An RFP 4/23/2025

    This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.

  7. 8 Actions To Redefine Sponsor–CDMO Relationships 4/22/2025

    When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.

  8. We Must Rethink The Solvents We Use For Peptide Synthesis 4/21/2025

    While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

  9. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

  10. Why You Need A Raw Material Control Strategy 4/17/2025

    You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.