BIO From The Editor and Guest Columns

  1. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    Faced with competing priorities, teams often rush to turn their plans into projects while missing the important steps in between. Resource planning is chief among these oversights. 

  2. Achieving Integrated Quality Through A Continued Process Verification Program

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

  3. Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework

    The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment, and largely replace freestyle text.

  4. Outsourcing Insights From A Tech Transfer Veteran

    Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.

  5. Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  6. The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

  7. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  8. Are Good Manufacturing Practices No Longer Good Enough?

    Janet Woodcock’s recent quote on the state of pharmaceutical development — “It’s not working…” — should not be a surprise to anyone. The industry has been struggling for years with long development times, high product failure rates, and frequent quality problems. But, Ms. Woodcock’s further statement — “and, it won’t work in the future” — is an especially troubling call for changes.

  9. Can Regulatory And Pharmacopeial Compliance Practices Establish Quality?

    The stated mandate of regulatory authorities (e.g. the FDA) and pharmacopeias (e.g. USP) is to establish and monitor safety, efficacy, and quality of manufactured drug products. This article examines the role of those authorities on quality during production processes.

  10. FDA FY2018 Human Tissue And Cell Therapy Observations And Trends

    This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.