Featured Bioprocessing Editorial

  1. Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies

    This is the second of two articles, this part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

  2. Cardiac Stem Cell Controversy — 3 Important Lessons Learned

    Over the past 20 years, hope has grown around the use of stem cells to enhance regeneration following a heart attack, wherein stem cells would facilitate tissue repair and help restore heart muscle function. However, the legitimacy of cardiac stem cell research is now being called into question.

  3. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  4. Continued Process Verification And The Validation Of Informatics Systems For Pharmaceutical Processing

    By Gloria Gadea-Lopez (Shire), Rob Dimitri (Shire), Rob Eames (GSK), Peter Hackel (Shire), Eric Hamann (Pfizer), Robin Payne (BioPhorum), Carly Cox (Pfizer), and Steve Kane (Shire)

  5. The Brexit Deal And Its Impact On The Pharmaceutical Industry

    According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.

  6. Paying For CAR-T: Reimbursement Insights For Cell & Gene Therapy Space

    While recent scientific breakthroughs for regenerative cell therapies are bringing great hope to patients and providers in desperate need of treatments and cures, how do you determine payment for something of enormously high value that has literally never existed before?

  7. 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.

  8. 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.

  9. 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.

  10. 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.