INSIGHTS ON QUALITY CONTROL

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?

  Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

• The Importance Of Having A Strong Reject Characterization Program

  Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.

• Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy

  The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.

• Development To Large-Scale cGMP Production

  7/25/2024

  For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

• Vial Breakage During Lyophilization: Root Causes And Mitigation

  10/16/2024

  Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

• Glucagon-Like Peptide-1 (GLP-1) Analogues Applications Notebook

  12/11/2025

  View this collection of application notes about the chromatographic analysis and purification of GLP-1 analogues, including Semaglutide, Tirzepatide, Liraglutide, and Exenatide.

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  12/8/2025

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• The Hidden Costs Of Paper Logbooks

  3/19/2026

  Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.