Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes. Process development is a key factor in the development and ...

In this webcast, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. Process characterization and validation is an ...

Process analytical technology in biomanufacturing has undergone a fundamental transformation over the past two decades, moving quality control from the analytical laboratory to the manufacturing floor ...

Bispecific antibodies have emerged as a rapidly growing biologic modality that can engage two distinct biological targets within a single molecule. Their unique mechanisms of action have created new ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...

Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...

Thought LeadersRobert HighamHead of CfAMUniversity of Bolton/Centre for Advanced Manufacturing Granutools is a Belgian company that specializes in powder flow characterization; the University of ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

The total amount of money invested in the project. The total cost includes EU contribution as well as other project costs not covered by EU funding. It is expressed in euros. Amount of money, by way ...

In this free webinar, learn how closed processing and cell line characterization can help reduce risk in cell bank manufacturing. The featured speakers will discuss contamination control, testing ...