Featured Editorial

  1. EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines 5/6/2025

    The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

  2. EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval 5/5/2025

    In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

  3. A Facilities Expert Answers Audience Questions On Construction And Validation 5/5/2025

    Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

  4. The Expanding Role Of CMC In Biotech Investor Decision-Making 5/5/2025

    With increasingly complex modalities, undruggable targets, rare diseases, and narrowly defined patient subpopulations, CMC is an important area of due diligence scrutiny for prospective investors and licensees. Part 1 of a two-part analysis.

  5. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

    From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

  6. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

  7. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

    Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

  8. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  9. 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.

  10. Experts' Advice On Facility Design And Construction 4/24/2025

    This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.