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...

Summary: While traditional fed-batch bioreactor process development has been well defined using methods such as shake flasks and bench-scale bioreactors, there is a desire to intensify...

Summary: As the need for accelerated biopharmaceutical development around the world continues to grow,  companies are facing complex challenges that need to be overcome to remain competitive for increasing process productivity...