In this webinar, experts will discuss how to improve the formulation development of high-concentration mAbs for subcutaneous delivery to reduce viscosity, and potentially reduce costs and timelines, and how to overcome current challenges met in formulating mRNA lipid nanoparticles (mRNA-LNP).

Summary: Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.

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.

Summary: Catalent’s SMARTag platform technology offers ADC and biologics innovators a toolkit to develop optimized ADCs and bioconjugates.

Summary: The field’s top experts weigh in on the technologies they are working on, including self-amplifying RNA, computer-designed nanoparticles, expanding mRNA processes and...