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...

Summary: Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and commercial success. The journey from cell line development...

Summary: Time is of the essence in the biopharmaceutical industry. How can developers ensure they get to the clinic as efficiently and smoothly as possible?

Summary: In this whitepaper, we describe a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs).

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: Biopharmaceutical products in development continue to increase in complexity. These include numerous multi-specific antibody platforms, proteins that require cleavage, or other additional post-translational modifications...

Get insights on key considerations for a successful process transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent