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.

• Building R&D Knowledge Into GMP Documentation

  Integrating R&D knowledge into GMP documentation ensures consistent aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling reliable, knowledge‑driven manufacturing.

• Science With Purpose: Advancing Sustainability In Biopharma Testing

  Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.

• Late‑Stage Progress In Excipients For Precision Nanomedicine

  View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.

• Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation

  3/5/2026

  Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.

• Compressed Gas Risk Assessment: A Significant Step In Your CCS

  10/10/2024

  Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

• Monitoring Microbial Contamination Of Mammalian Cell Cultures

  2/21/2025

  Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

• Straight From The Source: A Live Q&A With The Inventors Of KinetiSol™

  5/22/2026

  Experts discuss a solvent-free fusion process for amorphous solid dispersions, highlighting formulation flexibility, scale-up, process control, and early strategies to reduce risk and support commercialization.

• ISO/TR 14644 -21:2023 Cleanrooms And Associated Controlled Environments — Part 21: Airborne Particle Sampling Techniques.

  3/5/2026

  Avoid common sampling errors and ensure cleanroom compliance. Master correct probe placement and tubing configurations to align with the latest industry standards and improve data accuracy.