Most biopharmaceutical drugs (e.g. monoclonal antibodies, interleukins, and vaccines) must be parenterally administered because they become inactivated within the gastrointestinal tract. Parenteral administration circumvents the body’s most protective barriers, the skin and mucous membranes, so biologic drug products must be “essentially free” of contamination. As a result, biological drugs must be manufactured in adherence to current good manufacturing practices (cGMP) to provide an aseptic environment free from potential physical, chemical, and biological contaminants. The need for training and skills in the manufacture of biological drug products in an FDA regulated, cGMP environment continues to increase as therapies for targeted treatment of diseases such as cancer and autoimmune disorders advance.
This workshop will introduce participants to the history of FDA regulation of parenteral drug products and fundamental knowledge and skills required for entry level jobs in biologic drug product manufacturing. Participants will conduct cutting-edge hands-on laboratory activities that occur during the final fill & finish stage of biologic drug manufacturing, including drug stability assays, filter integrity validation, vial filling, stoppering, freeze-drying, drug inspection and gowning for aseptic processing. Additionally, the workshop will include guest lectures from industry experts and a tour of a contract manufacturing organization in Bloomington, IN.
At the conclusion of the mini-BIOMAN, participants will have a comprehensive, ready-to-insert curriculum module to utilize in their own classrooms. Curricular materials include PowerPoint slides and links to helpful resources and references as well as hands on activities. Breakfast and lunch will be provided each day of the conference, and transportation to off-site venues is included. Participation in all three days of the workshop is required.
* A limited number of travel stipends are available for out-of-town participants. *
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