CLINICAL SUPPLY MANUFACTURING ARTICLES
Beware The Manufacturing Bottleneck: Lessons From Inside
Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.”
CLINICAL SUPPLY MANUFACTURING RESOURCES
-
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
-
Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.
-
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
-
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
-
Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.
-
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
-
CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.