INSIGHTS ON QUALITY ASSURANCE

• What Does Annex 1 Mean For Cryovial Filling?

  New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.

• The Invaluable Asset Driving Advanced Therapies Forward

  Cell therapies are advancing rapidly, but manufacturing delays still limit patient access. Improving operational understanding, reducing risk, and strengthening collaboration may be just as critical.

• The Framework For Containment In A Cleanroom

  ISO classification decisions shape cleanroom design. Learn how early alignment between process needs, biosafety, and classification can reduce redesign risk while supporting scalable environments.

• Beyond Compliance: What Defines Quality Excellence In A CDMO

  Strong quality programs are built on more than audits. Explore how culture, systems, and continuous improvement support reliable manufacturing outcomes.

• Digital Transformation In Contract Manufacturing: A Leadership Perspective

  5/13/2025

  Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

• This Is Your Team At Cambrex

  1/29/2025

  We’re committed to helping our customers succeed and tackling challenges of any size. Meet the team of experts you’ll love collaborating with.

• How Robotic Isolator Technology Aligns To Annex 1 Principles

  4/28/2025

  Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

• Contamination Control Strategy: Compressed Gas Monitoring Of Microbes

  3/3/2026

  Microbial survival during gas decompression is a proven risk. Learn why point-of-use monitoring is essential for Annex 1 compliance and how to ensure process gas purity in sterile environments.

• Evaluating Carryover When Using A TOC Analyzer

  4/10/2026

  Accurate TOC results shouldn’t depend on sample order. See how low-level measurements remain reliable even after high-TOC analysis, helping reduce false positives and streamline decisions.