Guest Columns

  1. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

  2. The 6 Types of Bio/Pharmaceutical Consultants 10/26/2023

    In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support. 

  3. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  4. Proposed Best Practices For Cell & Gene Therapy Aseptic Process Simulation 10/25/2023

    Aseptic process simulation (APS) plays a critical role in demonstrating that the processes, equipment, and materials involved in sterile manufacturing work in synergy to maintain sterility. Applying existing APS guidelines to cell and gene therapies/ATMPs can be challenging, so BioPhorum proposes a best practice approach in alignment with regulatory guidance.

  5. Key Considerations For Cell & Gene Therapy Developers To Tap Into AI 10/24/2023

    In the authors' first article in this two-part series, they discussed the opportunities for AI to assist cell and gene therapy companies. In this second article, they examine how cell and gene therapy developers can wisely harness AI, with a look at outsourcing vs. developing in-house solutions, data acquisition strategies, the three stages of managing AI/ML algorithms, and more.

  6. 5 Key Considerations For MES Vendor Selection 10/20/2023

    Have you made a strategic business decision to implement a manufacturing execution system (MES)? Selecting a MES vendor is a strategic and thoughtful process. With these five considerations, you can give some thought to how MES fits into your enterprise landscape and your business requirements.

  7. FDA Warning Letters Dipped, But Don’t Get Cozy 10/19/2023

    Between October last year and March this year, FDA inspectors showed a heightened level of discretion for OAI inspections, choosing to withhold enforcement action. This isn't an invitation to breathe easy; there's a reasonable explanation for less enforcement action.

  8. Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses 10/18/2023

    Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.

  9. Macro Trends In Bio/Pharma Manufacturing We’ll See More Of In 2024 10/16/2023

    As we get closer to the end of the calendar year, pharma/biotech manufacturers should keep an eye on the trends that will impact the industry as we head into 2024. We caught up with Laks Pernenkil, principal and life sciences product, supply, and manufacturing operations practice leader at Deloitte Consulting LLP, to discuss.

  10. Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations 10/12/2023

    Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.