Recent advances in expression technology have made fungi and other microbial eukaryotes viable alternatives for the production of monoclonal antibodies and antibody fragments. The technical, regulatory and intellectual property issues involved in the use of microbial hosts for the production of biopharmaceuticals will be discussed.



Objectives:

Understand the state of the art in alternative microbial production hosts for human therapeutics.

Gain information of novel tools for use in screening novel human therapeutics (e.g., HTS in fungi).

Learn the regulatory process for approval of these "new" production hosts.