Catalent Biologics’ Limoges, France site is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish. The site offers an integrated facility with a small-scale filling line, in-house analytical capabilities, quality control labs, cold storage, and regulatory support.
Summary: For Contract Development and Manufacturing Organizations (CDMOs), transitioning to Biopharma 4.0 is crucial – the data and expertise amassed by these manufacturers represent an integral asset for their customers working to innovate in an increasingly competitive and fast-paced market.
Listen in as Mike and Darren share how new modalities and manufacturing technologies have altered the partnership landscape between developers and CDMOs.
Summary: In this webinar, we explore the drivers for process characterization and late-phase development including improving process understanding, enhancing robustness, and assurance that it delivers…
Summary: Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches commercial launch…
Summary: In this article, experts detail how drug developers overcome obstacles that may complicate the launch of orphan drugs in order to meet their own needs and the needs of patients.
