11.11.25 -- What You Should Know About USP's Bioassay Updates

For groundbreaking genetic treatments, stringent quality control is non-negotiable. This exploration delves into defining essential attributes and the analytical tools that safeguard their consistent production.

How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.

Learn how optimized, customizable formulations and Excipient GMP manufacturing streamline development, ensuring quality and consistency for a de-risked path to the clinic.

Explore in detail how certain vials and elastomer stoppers provide significantly better protection than corresponding borosilicate glass vials and elastomer stoppers without an effective barrier film.

Discover how spatial profiling and advanced imaging tools are transforming drug discovery, featuring Wayne Stallaert’s lab’s work on cell cycle mapping and biomarker insights in cancer research.

A new functionally-closed cell expansion system featuring a hollow-fiber membrane and customizable protocols is streamlining the production of stem cells for regenerative medicine.

New bioreactor technology provides an optimal environment for shear-sensitive cells, addressing key scale-up challenges for allogeneic therapies from research to commercial production.

Multi-well inserts allowing for a two-chamber system that can expose cell cultures from above and below provide greater versatility and expand research options compared to standard cell culture plates.

Scalability remains a key bottleneck in CGT manufacturing. See how optimized stirred-tank bioreactor systems accelerate translation from clinical to commercial production.

Typically, devices containing depth media filters offer more efficient filtration. Browse depth filtration products for the downstream processing of cell culture solutions, fermentation broths, and lysates.

Here, we detail the upstream process development and optimization for an AAV8-GFP proof-of-concept (PoC) producer single cell clone (SCC) in both batch and perfusion modes.