Summary: Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development...

Summary: While peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common...

Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method...

Summary: There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify...

Summary: Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial

Summary: Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based...

Summary: Biologic development is complex, requiring a significant amount of time and resources to ensure the best chance of success. Consequently, there are numerous aspects...

Summary: Explore our suite of proprietary technology platforms and range of integrated development, manufacturing and clinical supply services. Catalent Biologics partners with leading biologic and...

Summary: OneBio™Suite is a single solution integrating development through complete clinical and commercial supply to simplify, accelerate and de-risk...

Summary: Many, if not most, small and midsized biopharma companies choose to partner with outside vendors—contract development and manufacturing organization, or CDMOs—to handle their end-to-end biologic...