Featured Bioprocessing Editorial

  1. Biopharma Quality Systems Need Revamp To Accommodate Digital Health Tech

    As biopharmaceutical companies develop and market more medical devices and combination products with digital health components, the FDA and industry experts caution about regulatory and business risks.

  2. Top 5 Ways To Get The Most Out Of A Supplier Audit

    Your outsourcing may come in the form of manufacturing of a sterile injectable, tablets, or topical dosage form or it may be GMP product release and stability testing. The product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The suppliers you choose are of paramount importance to your company’s success.

  3. Advanced Auditing Strategies To Detect Data Integrity Risks

    Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.

  4. Quality Risk Management And The Draft Annex 1 Revision — What To Expect

    The PIC/S Inspectors Working Group is preparing to finalize the EMA Annex 1, Manufacture of Sterile Medicinal Product, guidance/GMPs. The revision, an overhaul of the 2008 version of the annex, attempts to clarify many issues and concerns specific to aseptic processing of sterile medicinal products.

  5. Beyond The IND: Regulatory And Clinical Planning For Cell And Gene Therapies

    A quick and nimble approach is often sought after in the cell and gene therapy product space due to the likely one-time or limited patient dosing and/or rare disease conditions limiting the number of available patients, which reduces the number of clinical studies.

  6. Early Formulation Development RFPs Made Easy

    RFPs for early formulation development are different from tech transfers, clinical supplies, and other RFP strategies because the scope requirements need more flexibility to accommodate the unknowns of R&D. 

  7. Fault Tree Analysis: Uncover The Root Causes Of More Complex Problems

    A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.

  8. Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies

    With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.

  9. Help! My Isolator Is Taking Too Long To Degas — What Should I Do?

    Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

  10. How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

    On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.