04.03.24 -- Reducing Clinical Holds On CGT: Approaches For Sponsors And The FDA

Delve into the current emphasis on separate cleaning and disinfecting steps, which reflects current best practices, and the most up-to-date rewrite of the EU Annex 1.

A side-by-side comparison was performed using a CIMmultus SO3—1 mL (2 µm) column and a commercially available affinity resin that binds several AAV serotypes.

Craft a flexible manufacturing roadmap, a dynamic tool evolving with automation needs and processes. Vital for clarity, it maps the entire process, answering key questions for effective development.

Explore how to develop a strong packaging system, and why a reliable supply chain is critical for drug substance and drug product transport.

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Benzonase endonuclease is a high-quality product that delivers value to viral vector processes. Here, we highlight an optimization strategy and process economics of DNA digestion in viral vector purification.

Uncover details about a liver-chip that offers a more human-relevant way of testing viral vectors compared to conventional models and why it is a promising tool for advancing AAV gene therapy.

Examine continuous models of oxygen, k_La, and specific power input (power per volume or P/V) in 250mL and 5L bioreactors to scale up and compare bioreactor performance metrics.

See how PCR-based Mycoplasma detection assays can provide a rapid alternative to culturing with comparable sensitivity, specificity, and species range that can facilitate quick decision-making.