Featured Articles

1. FAQs On The Revised EU GMP Annex 1: Volume 6 9/21/2025

   The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

2. Taking A Best Practice Approach To Contamination Control  9/21/2025

   Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

3. Laying Supply Chain Foundations That Bring Confidence To Compliance 9/21/2025

   Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

4. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

   The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

5. Vial Adapter Transfer Device Compatibility With Cell Therapies 7/25/2025

   Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

6. Vial Adapter Considerations For Cell And Gene Therapy Applications 4/21/2025

   Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.

7. Vial Containment Systems For Gene Therapies: Series Summary 4/9/2025

   Proactively understanding containment system performance can streamline development and accelerate market delivery. Review comparative data for CZ-based systems and traditional glass or polypropylene options.

8. Vial Containment Systems For Gene Therapies: Recovery Of Viral Vectors 4/9/2025

   Vial containment systems were evaluated for maintenance of virus transducability after storage at ultralow temperature. All vectors showed equivalent or better function compared to standard systems.

9. Vial Containment Systems For Gene Therapies: Container Closure Integrity 4/9/2025

   Maintenance of CCI at ultra-low temperature is a necessity for a gene therapy vial containment system. Systems comprising cyclic olefin polymer vials and elastomer stoppers with a barrier film were evaluated over time.

10. Vial Containment Systems For Gene Therapies: Materials Considerations 4/9/2025

    Storage of a vial containment system at ultra-low temperature presents risk not encountered at ambient temperature. Review material advantages of cyclic olefin polymer vials.