BIO From The Editor and Guest Columns

  1. The 4 Most Notable Biosimilar Interchangeability Hurdles

    Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

  2. 9 Steps To Successfully Embed Quality Personnel On The Shop Floor (And Why It’s Important)

    It’s Saturday night in a pharmaceutical manufacturing facility, around 11:30 pm, when the alarm goes off in the aseptic processing area. There has been a positive pressure breach, and the area is compromised.  The manufacturing staff quickly closes the product tank and moves it to the proper storage area.  But what should happen next?  There are no quality personnel on the shop floor over the weekend, so no one is present to review the containment actions taken or to discuss what the next steps should be from a compliance perspective. 

  3. IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

    I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

  4. Is GMP Quality System Auditing Fundamentally Flawed? — A Data Integrity Alternative

    A quality systems approach to GMP auditing has become common practice among both regulatory authorities and internal audit programs at pharmaceutical companies. The method originated with the FDA Center for Devices and Radiological Health’s (CDRH) Quality System Inspection Technique (QSIT), introduced to the medical device industry in August 1999, and was later adopted by the Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) for pharmaceutical drug inspections.

  5. 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  6. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    There are many regulations and guidance documents that discuss disinfectant efficacy testing, and establishing a compliant disinfectant efficacy testing package aids in providing clear documentation that the disinfectants employed in a facility have been analyzed as required by these regulations.

  7. Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy

    A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.

  8. 7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

  9. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  10. Should Your Biosimilar Really Be A Biobetter?

    A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.