02.18.26 -- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy

Discover essential analytical techniques in biotherapeutics development, as well as explore ITC, DSC, and Rheology—powerful tools for understanding formulation, stability, and efficacy in drug development.

Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.

A holistic approach to CCI shifts focus from end-product testing to built-in quality across the lifecycle. Learn how science- and risk-based strategies can strengthen sterility assurance.

Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).

Boost downstream efficiency with multi-column chromatography for polishing to achieve higher productivity, reduced resin costs, and automated operation while maintaining purity and recovery.

Therapeutic peptide purity is critical. Gain insight about SEC analysis of high molecular weight impurities in Insulin Glargine and Insulin Lispro to ensure product quality and safety.

New antibody formats present new purification challenges due to novel impurity profiles. New methods and media are required to ensure safe, effective, and scalable manufacturing of these biologics.

Streamline protein and antibody purification with an automated TFF system featuring real-time, in-line concentration measurement for enhanced accuracy, reliability, and cGMP compliance.

Sterile drug filtration demands rigorous integrity testing to prevent contamination. See how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.