Summary: In a recent presentation during the 2024 JP Morgan Healthcare Conference, Catalent’s Group President of Biologics Dave McErlane addresses the latest market drivers for Biologics and Sterile Injectables.

In this article, experts provide an overview of current challenges associated with high-concentration protein formulations and in formulating mRNA lipid nanoparticles (mRNA-LNP) and how to overcome them.

Watch this expert panel discussing the increased emphasis on risk management and contamination control strategies across the industry.

In this webinar experts cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.

In this webinar, Chemistry Nobel Laureate, Carolyn Bertozzi, Ph.D., Professor, Stanford University, Penelope Drake, Ph.D., Head of R&D, Bioconjugates, Catalent Biologics, and Seema Kantak, Ph.D., Senior Vice President, Biotherapeutics, Exelixis, discuss the latest trends in ADC discovery and development.

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).

Catalent’s Anagni facility is a world-class, late-stage and commercial product launch site offering sterile and biologics manufacturing & secondary packaging with extensive expertise in aseptic liquid vial filling.

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.

This article describes the benefits of transitioning from IV to SQ administration, considers the advantages of using PFSs, and explores challenges and solutions for transitioning from vials to PFS.