11.26.25 -- How CMC And MSAT Teams Consider PATs

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Inline buffer formulation leverages real-time, precise buffer preparation throughout production, enabling agile, efficient, and scalable manufacturing processes that save time and resources.

AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.

Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.

Cell and gene therapies require adaptive and advanced assays for characterization and safety assessments, and assays historically used for biologics must diversify to accommodate them.

Advancements in recombinant protein production have improved efficiency and quality. However, optimizing cell culture media remains key to ensuring maximized yield and desirable product attributes.

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Efficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.

A team of researchers sought to explore the viral infection process before the virus has bonded to tissue to better understand how viruses navigate the epithelial space through mucus and the periciliary layer.

Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

In the biopharmaceutical development world, Quality by Design cuts risk, streamlines processes, and speeds up regulatory approval.

Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits.

Could a new approach to operator training help minimize batch loss? Learn how blended learning can enhance training effectiveness and engagement, reducing human error in your production line.

Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

See how total protein staining offers a robust approach to western blot normalization to minimize variability and improve quantification accuracy, which supports reproducible protein expression.

Discover a platform that supports intensified purification strategies with high binding capacity, fast throughput, and robust stability, making it ideal for scaling therapeutic production.

Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.

See why single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage at cold temperatures.

Learn five critical considerations for freezing bottles, including uniform rate control, container integrity, and selecting the right freezing technology to maintain product stability and process efficiency.