07.07.26 -- AI Has Arrived In Biotech CMC Amid Patchwork Governance

Watch how tailored media solutions and scalable manufacturing practices support efficient bioprocess development, ensuring your production lines remain reliable and ready for future demands.

Legacy facilities weren't built for today's cold chain complexity. How are CDMOs squeezing more capacity from fixed footprints without breaking what already works?

Understand the manufacturing challenges where rapid cell expansion often conflicts with therapeutic secretion profiles, requiring sophisticated quality control and donor selection strategies.

Discover how T-cell culture media supplemented with key cytokines can maintain full functionality and support robust expansion for up to 12 days at room temperature.

Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.

It's important to evaluate your starting point when scaling an upstream process. Review key considerations for deciding between adherent and suspension cells to optimize your gene therapy process.

Examine protocols for scaling down process steps, spiking viruses into intermediates, and measuring clearance to ensure regulatory compliance and safety during therapeutic manufacturing.

Annex 1’s updated CCS framework calls for a holistic contamination strategy. Learn how manufacturers can apply it to non-sterile sites and legacy facilities using tailored risk-based approaches.

Maximize mesenchymal stem cell (MSC) expansion with a simplified culture process. New data demonstrates a high-performance, xeno-free media that eliminates the need for coatings or media exchanges.

Targeted lentiviral vectors enable rapid CAR‑T cell generation without extensive ex vivo manipulation. See how this approach demonstrates efficient in vitro and in vivo performance.