04.14.26 -- Protecting Biopharma Manufacturing Supply Chains

Experts address key USP <665> questions, including risk assessment, testing approaches, extractables and leachables, and practical challenges in implementing single‑use systems in manufacturing.

A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.

Discover how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.

AI, ML, NLP, and other in‑silico tools are transforming biologics formulation by enabling earlier risk assessment, better formulatability predictions, and faster preclinical workflows.

PCC boosts Protein A capture efficiency, cuts resin costs, increases productivity, and enables continuous downstream processing without sacrificing quality or compliance.

Orphan drug development is a journey marked by challenges at every step. From patient recruitment to aseptic fill finish, overcoming hurdles is critical for bringing life-saving treatments to market.

Evolving science, contamination cases, and regulatory shifts shaped modern viral‑safety standards, prompting adoption of inactivation, filtration, molecular detection, and risk‑based methods.