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.

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.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.