Featured Bioprocessing Editorial

  1. Commissioning & Qualifying: Facility Considerations For Tissue Engineering 11/7/2024

    This article provides an overview of the facility considerations for tissue engineering. It includes a comparison of a bulk biologics facility, which aids the discussion.

  2. Biopharmaceutical Fermentation Systems' Growing Role In Modern Medicine 11/6/2024

    Bioreactors, culture media, growth factors, and sensors are essential to foster microbial or cell growth in optimal conditions.

  3. How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery 11/5/2024

    Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.

  4. Peptide Synthesis: New Market Research 11/3/2024

    Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.

  5. Maintaining Harmony With Your CDMO Using 'The Middle Way' 10/31/2024

    Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.

  6. A Comprehensive Guide For Supplier Quality Agreements 10/29/2024

    This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.

  7. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  8. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

  9. Safety Cabinets' Essential Role In EU GMP Annex 1 10/25/2024

    A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.

  10. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.