Automated facility upgrades for cell therapy enhance quality assurance, ensure regulatory compliance, and boost operational efficiency by minimizing manual risks.

Strategic AI integration in bio/pharma manufacturing enhances GxP compliance, quality, and operational efficiency through robust governance and risk management.

Aaron Crowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs.

Telix will now include an additional, confirmatory efficacy study analysis of existing data, hoping to satisfy FDA’s request for supplemental evidence and address concerns raised in a complete response letter.

Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

Integra has secured €10.7 million (US$12.6 million) in funding for its FiCAT gene writing platform to enhance precise DNA integration for CAR-T engineering and rare disease therapy development.

Experts to share strategies on scale-up, process intensification, and data-driven methods shaping future stem cell manufacturing and therapies.

Allogeneic CAR-T therapies deliver scalable, off-the-shelf cancer therapy, while autologous CAR-T therapies provide patient-specific but time-intensive treatment.

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

The nonprofit is calling upon its community of experts in both artificial intelligence and machine learning to continue building support for responsible adoption of AI in the bio/pharmaceutical industry.

This collaboration between Andelyn Biosciences and Tern Therapeutics moves the gene therapy TTX-381 closer to approval for treating vision loss linked to CLN2 Batten disease.

FDA’s fast track designation may speed VMX-C001’s application review, addressing urgent surgery needs in patients on Factor Xa anticoagulants.

The partnership, which has received £118 million (US$158 million) in research funding, aims to establish a better understanding not only of how the body fights infection, but also how vaccines protect it.

A joint venture between the two entities will integrate mRNA synthesis, LNP formulation, and clinical testing to speed therapies from plasmid design to first-in-human trials.

Aptamer will create Optimer binders for Invizius’ H-Guard technology to enhance complement-targeting therapies for safer, more precise treatments for immune disorders.