Manufacture of a Ricin Antitoxin.

Descriptions

The Authority has a requirement for a ricin antitoxin medicinal product that is licensed for adult human use. The product is intended for use as a lifesaving treatment following ricin toxin poisoning and in particular from exposure to the toxin by the inhalation route. The Authority is seeking a Contractor to produce de-speciated F(ab')2 anti-ricin antibodies as a lyophilised product. These antibodies are to be generated in a mammalian species and must be capable of neutralising ricin toxin activity following reconstitution. The therapeutic antibody Drug Product F(ab')2 is to be stable for a minimum of 3 years when stored at 5°C. The Contractor must be able to demonstrate compliance with current Good Manufacturing Practice (cGMP).