Plasmid DNA is a vital component in the production of viral and nonviral cell and gene therapies (CGT). Catalent's innovative UpTempo℠ Plasmid Platform Process has revolutionized plasmid DNA manufacturing by addressing key challenges and significantly reducing development time.

Catalent Biologics’ Limoges, France development center is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish.

Catalent’s mammalian cell line engineering and biomanufacturing capabilities, utilizing single-use systems, provide the flexibility and scalability needed to support our customers' growth.

Forced degradation studies are essential to the successful development of monoclonal antibodies (mAbs), bispecifics, and other biologics.

Summary: Catalent’s SMARTag® Technology offers a versatile and innovative platform for the development of optimized antibody-drug conjugates (ADCs).

Abstract: In the iPSC derived cell therapy world, developing a suitable iPSC line is a key step, but not the only one.

This webinar will bring together industry leaders to discuss innovative strategies and practical solutions for manufacturing protein-based modality therapies.

Forced degradation studies are crucial for developing recombinant monoclonal antibody therapeutics, aiding in everything from early manufacturability checks to comparability assessments before and after marketing approval.

Join Vincy Abraham, Director of Biologics Analytical Services, to discover how Catalent leverages its extensive expertise and capabilities to deliver tailored solutions to meet specific analytical needs for your biotherapeutics.

Summary: Catalent has successfully addressed the challenges associated with plasmid DNA manufacturing by developing robust process and analytical platforms. Catalent’s approach involves a one-process-fits-all single-use (SU) manufacturing process in compliance with current good manufacturing practices (cGMP) standards.