Tuesday, 23 July 2019

Bispecific Antibody Development Programs - FDA

Image: Dr Josehp Ndieyira of UCL Medicine

The general regulatory and scientific considerations for bispecific antibodies, is a growing area of interest.
A new guidance document from the FDA, which refers to: “This guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies. Discussion includes general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. This guidance does not discuss development considerations for other multitarget therapies that are combinations of monoclonal antibodies or are antibody cocktails or polyclonal antibodies. Although this guidance is specific to bispecific antibodies, the principles discussed in this guidance may also be applicable to the development of other types of bispecific protein products.”

For details, see FDA - https://www.fda.gov/media/123313/download

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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