Featured Bioprocessing Editorial

  1. A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges

    The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This article highlights technology opportunities for gene therapy manufacturing.

  2. Inside FDA's Proposed Program To Establish Voluntary Quality Standards

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  3. An Introduction To Centerlining For Pharmaceutical Manufacturing

    Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.

  4. Cleaning, Sanitizing, Sterilizing, Or Wishing It Away: What Are We Doing To Control Bioburden?

    Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.

  5. Toward A More Robust Regenerative Medicine Regulatory Pathway

    In recent months, the U.S. Food and Drug Administration has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P), many of which are used in orthopedics.

  6. Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

    This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.

  7. Refrigerated Transport For Gene Therapies: Exploring The Pros And Cons

    In the first part of this two-part article, common cryogenic shipping methods for gene therapy products were presented, and pros and cons of each method were discussed. In this part, major refrigerated transport methods of gene therapy intermediates will be addressed.

  8. What’s In A Name? FDA Proposes Updates To Its Biosimilar Naming Policy

    The U.S. FDA issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update. This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products.

  9. What Should You Do After An FDA Inspection?

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  10. 4 Strategies For Success In The CAR-T 2.0 Marketplace

    As the second wave of CAR-T therapies begins coming to market in the next five years, their manufacturers will need to anticipate and prepare to address many of the same commercial challenges as their predecessors, as well as several additional ones.