GUEST COLUMNISTS

• Understanding The Importance Of Real-time Monitoring For Protein Aggregation

  BioSolution’s Danny Chou, Ph.D., Pharm.D., breaks down the advantages of real-time monitoring for protein therapeutics, including how these approaches can accelerate timelines, produce better data, and smooth regulatory compliance.

• Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2

  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.

• The 6 Types of Bio/Pharmaceutical Consultants

  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. 

• FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

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

• FDA Warning Letters Dipped, But Don’t Get Cozy

  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.

• Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses

  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.

• Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations

  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.