06.04.25 -- First AMT Program OK'd Under New FDA Designation — Here's What To Know

Rigorous validation of immunogenicity assays is crucial for ensuring safety and efficacy, especially in the evolving regulatory landscape. Discover the importance of understanding regulatory standards.

Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management and future market trends.

Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

Understanding the intricacies of cell and gene therapy naming conventions can be confusing but necessary for navigating the development pathway to bring these advanced therapies to market.

New EU rules tighten grip on contamination control for sterile drugs. Learn how to ensure your cleaning and disinfection meet the stricter standards.

Discover insights tailored specifically for drug product researchers and manufacturers, offering key knowledge on extractables, leachables, and effective implementation strategies.

Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

With evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.