Guest Columns

  1. Using The QTA To Align Data-Integrity Expectations

    Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.

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

    Bioburden is mobile, growing, contaminating, and touching everything we do, but it can be controlled if we understand it and follow some basic concepts. This article will focus on the EU grades B, C, D, and CNC in biotech and aseptic facilities.

  3. 5 More Best Practices MSD Regulatory Affairs Used To Implement Strategic Sourcing Partnerships

    The first article in this two-part series described five best practices Merck undertook to effectively extend its capacity through strategic outsourcing to external partners. Here are the final five best practices, which focus on building a strong foundation with external partners.

  4. The Unique Demands of Cell and Gene Therapy Supply Chains

    Three cell and gene therapy sector SMEs representing industry and academia explain supply chain challenges and viable solutions.

  5. CDMO Selection: 3 Questions To Save Time And Reduce Stress When Reviewing An MSA

    Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) and Supply Agreement execution can be time consuming and difficult. At any given pharma company in the development or clinical stage, the leadership team and investors prioritize patients, therapies, and trial results.

  6. Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

    This article is the first part of two-part article that will discuss objectionable microorganisms recovered from nonsterile products. In this part, we will explore what constitutes an objectionable microorganism, as well as the regulatory expectations for objectionable microorganisms in nonsterile products.

  7. Refrigerated Transport For Gene Therapy Products — Exploring The Pros And Cons

    The viability and cell count of immunotherapies are extremely sensitive to temperature. Additionally, these products demonstrate reactivity to cooling and thawing rates between room temperature and refrigerated/frozen temperatures.1 The same sensitivity applies to apheresis material, which is susceptible to failure if not fully protected against temperature fluctuations.

  8. Analytical Testing Strategies For Clinical And Commercial Operations

    A summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy for clinical-material release.

  9. 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 (“guidance”). This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products. It also highlights the perceived tension between the FDA’s pharmacovigilance role and its goal of increasing the availability of biosimilars. At least for this round, the FDA’s interest in tracking pharmacovigilance data seems to have received priority.

  10. 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.