End-to-end Biologics Development Solutions
The acquisition and integration of Cook Pharmica LLC’s business and facility into Catalent’s global biologics network facilities allow its clients to benefit from end-to-end solutions in biologic drug development.
The acquisition and integration of Cook Pharmica LLC’s business and facility in Bloomington, Indiana, into Catalent’s global biologics network allow its clients to benefit from end-to-end solutions in biologic drug development.
The capabilities of the Bloomington site, which include clinical and commercial biomanufacturing capacity as well as extensive expertise in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges, complement Catalent’s biologics expertise to provide a single, integrated partner supporting a wide range of clinical and commercial needs.
Catalent Biologics’ network includes a state-of-the-art development and biomanufacturing facility in Madison, Wisconsin; fill-finish services in Brussels, Belgium and Limoges, France; SMARTag® antibody-drug conjugation technology in Emeryville, California; and a network of biologics analytical locations.
Investment and expansion has recently been undertaken at the Madison facility to accommodate two new, 2,000 liter single-use bioreactor systems. This allows the site to support late-phase clinical and commercial production of up to 4,000-liter batches, and analytical and process development laboratories at the site have also been expanded to meet the greater capacity and capabilities.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Your Ultimate Guide for CMC Testing Support for Gene and Cell Therapy
November 21st 2024Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.
