Summary: OneBio™ Suite provides integrated biologics development, manufacturing and supply with a single solution from cell line development through clinical supply. OneBio Suite is designed...

Summary: The propensity of a protein to degrade under stress can vary widely among proteins and is important to understand in pharmaceutical development. A model protein, adalimumab, was tested by a limited...

Summary: This poster evaluates the degradation of a therapeutic mAb, Adalimumab, resulting from light, shear and thermal stress.  Degradation was evaluated using a combination of Sedimentation...

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: 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: 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: Changes during purification, formulation, fill-finish, and distribution can affect protein stability and practically all steps in the manufacturing process may perturb the higher-order structure and heterogeneity of the molecule...

Summary: Learn about the new strategy model for outsourcing - When two or more parties begin with a candid, transparent, and well thought-out process to full...