Featured Articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Vial Containment Systems: Interactions With Glass, Polymer, And Elastomer 4/9/2025

   Explore how certain vials and elastomer stoppers provide better protection than corresponding borosilicate glass vials and elastomer stoppers without a barrier film.

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

   This chapter discusses basics of gene therapies, including function, anticipated growth rates, companies involved and estimates of therapies in pipeline, and examples of commercial products and indications.

8. FAQs On The Revised EU GMP Annex 1: Volume 2 3/5/2025

   Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

9. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

   The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

10. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.