02.10.26 -- Smarter Partnerships And Faster Pathways In Advanced Therapeutics

Selecting a CDMO is a high-stakes strategic decision impacting quality, timelines, and regulatory success. The right partner offers integrated capabilities, scientific expertise, agility, transparency, innovation, and shared purpose.

Read how a new partnership is advancing base editing therapy for sickle cell disease, combining cutting-edge science with streamlined manufacturing to accelerate clinical trials.

A risk-based framework for identity testing of ancillary raw materials in gene therapy is presented, with emphasis on implementation based on product contact, material classification, and manufacturing stage.

Are you in need of an experienced and flexible GMP service provider that can assist you with the development and manufacturing of your gene or cell therapy with CMC support?

Cell therapy process development and clinical manufacturing began in July to expand global capabilities and deliver autologous and allogeneic production across three continents.

Accelerate your biopharma journey with a comprehensive service portfolio designed to speed development, reduce costs, and minimize risk from molecule to market.

Specialized cell collection services depend on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.

An integrated technology platform combines orchestration and patient-support systems to accelerate access to cell and gene therapies, improving connectivity, visibility, and coordination across the entire treatment journey.

An AAV platform process is a scalable, cGMP-ready process for viral vector manufacturing that can reduce the current 18-20-month development timeline for drug product in half.

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

Discover how a fixed-bed bioreactor supports the scalable manufacturing of both AAV and oncolytic virus therapies, detailing successful process development and scale-up strategies.

Pre‑approval inspection readiness requires embedding quality, traceability, contamination control, and robust analytical and documentation practices into everyday cell therapy manufacturing to prevent delays and ensure regulatory confidence.