Abstract: For decades, biologics stability programs followed a predictable playbook: generate data, support regulatory filings, satisfy agencies, and move on.

Abstract: Catalent's biologics analytical services are designed to deliver comprehensive support for a diverse range of biologic modalities, including antibodies, conjugates, peptides, nucleic acids, and cell and gene therapies.

Catalent has expanded its industry‑leading GPEx® Lightning platform to include HEK cell line development, creating a new standard for speed, expression control, and product quality in human-cell–based manufacturing.

Summary: This poster presents a customized mass spectrometry approach for sub-ppm quantitation of high-risk host cell proteins (HCPs) considered critical quality attributes.

Summary: This presentation introduces a systematic, data-driven approach for assessing the developability of biologic therapeutics, with a focus on pre-formulation development.

Summary: Catalent’s Bio Early Phase Success Package delivers an integrated analytical strategy designed to de-risk biologics development from discovery through IND.

Summary: This presentation introduces a systematic, data-driven approach for assessing the developability of biologic therapeutics, with a focus on pre-formulation development.

Summary: Characterizing molecular stability early is critical to advancing biologics through development and into the clinic.

In this webinar, Pedro Morales, Director and Scientific Advisor at Catalent, showcases how the Kansas City site delivers tailored analytical solutions to support biologics development from discovery through commercialization.

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