In this article, Catalent explores protein variants, focusing on charged variants, by outlining their impact on protein-based drugs, and explain how specific characterization techniques can be used to determine product safety and efficacy.

Summary: Catalent Biologics provides characterization and GMP support for a full spectrum of biologics including advanced modalities, such as cell and gene therapies, mRNA, and antibody-drug conjugates (ADCs).

Summary: Catalent offers a comprehensive suite of bioassay development services for traditional biologics and advanced therapies, such as antibody-drug conjugates (ADCs), cell and gene therapies, and mRNA vaccines.

Catalent's UpTempo AAV platform process offers clients accelerated timelines for producing their clinical materials. The scalable, CGMP-ready platform process can significantly reduce the time from gene to clinic through a simplified supply chain.

Catalent experts discuss UpTempo℠ AAV, a one-stop integrated viral vector platform for speed to clinic. Discover how implementing the right process, utilizing a clonal HEK293 cell line, and leveraging a range of off-the-shelf plasmids, along with qualified analytical methods, can support a robust supply chain for the development and manufacture of AAV vectors.

Learn about pluripotent stem cells and how they're being explored as an exciting alternative gene therapy technology with the potential to transform the field of regenerative medicine.

In recent years, the field of gene therapy has witnessed remarkable achievements and advancements. These breakthroughs have brought us even closer to unleashing the full potential of gene therapies. Catalent gene therapy experts discuss all aspects of gene therapy commercialization in depth.

A poster presentation of a GMP manufacturing process for the creation of human iPSC for use in allogeneic cell therapy applications.

A poster presentation of the UpTempo CAR-T Manufacturing Platform.

Learn how Catalent took to a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.