PHAR 5320
Microbial Fermentation & Drug Development, includes Formulation/ Delivery of Proteins/Abs & Drug Regulatory Affairs – Health & Life Sciences
Module Leader: Randolph Arroo
Module Characteristics
- The module is concerned with the role of microbial fermentation in modern drug development. Expression of biopharmaceuticals and challenges associated with scale-up, bulk production, and downstream processing will be discussed.
- Students will be made familiar with purification and physical characterisation of pharmaceutical products obtained by fermentation, and with the laws that govern safe disposal of waste products.
- Bio-safety and toxicological issues in the development of biopharmaceuticals will be discussed. Cytochrome P450-mediated cellular toxicity of biopharmaceuticals will be evaluated.
- An overview will be provided of the registration procedures for biotechnological medicines, including an understanding of the information that would be required to gain an authorisation for a new product. Important parts of these information requirements concern the formulation, manufacture, stability and potential toxicity of new biotechnology products.
- The properties of therapeutic proteins and antibodies produced in different cell factories, the modifications they undergo, and the resulting modes of targeting and delivery to particular types or tissue, will also be discussed in this module.
