Featured Articles

1. 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.

2. 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.

3. 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.

4. Achieving EU GMP Annex 1 Compliance For Contamination Control 3/4/2025

   Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

5. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

   Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

6. Vial Containment Systems Based On Elastomer 4031/45 Gray 10/1/2024

   Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.

7. Improve Speed To Market By Mitigating Vial And Stopper Incompatibility 10/1/2024

   These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

8. Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations 9/3/2024

   The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

9. Ready-To-Use Nested Vial In Tub: New Design And Packaging Configuration 9/3/2024

   With the increasing demand for cell and gene therapies, CZ nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

10. Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications 9/3/2024

    A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.