12.03.25 -- The Moral Economics Of Precision Medicine

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.

Though conducting your clinical trial in Australia may initially seem daunting, the benefits are ample. Australia is home to qualified CRO partners that will guide your CGT to regulatory success.

Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.

Sterility testing is susceptible to contamination, resulting in costly false positives, batch failures, and production delays. Isolator technology offers a robust solution to mitigate these challenges.

Navigate the complexities of PUPSIT with expert guidance. Discover best practices for assembly design, regulatory compliance, and troubleshooting common challenges in sterile filtration environments.

BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Assimilate how digital solutions streamlined their operations and improved regulatory efficiency.

In-process and quality control ensure manufacturing of gene-engineered hematopoietic stem cells. See an engineering process that enhances production through viral transduction and integrated sampling pouches.

Learn how real-time monitoring and PAT platforms can streamline bioprocessing, reduce testing delays, and improve decision-making across upstream and downstream workflows.

Mycoplasma contamination poses a significant risk to biopharmaceutical products and patient safety. Delve into how implementing a NAT-based testing method can enhance quality control and efficiency.