Published by University of Austin. Found at: Center for Open Education, University of Minnesota’s College of Education and Human Development. While not officially a biotechnology textbook, this open resource does discuss biomanufacturing through the lens of Quality Control and regulation by USFDA.
Category: BIOT 210
Primary resource for rules and regulations for biological manufacturing. Links can be found for guidance documents, standards, rules and regulations, advanced manufacturing, and biotechnology inspection guide.
Some material is available as open access, including articles, case studies, standards, and resources. Submit reprint and use permission request.
The NBC2 Biomanufacturing Laboratory Manual is a companion piece to the Introduction to Biomanufacturing textbook. The lab manual is SOP-driven and follows the content order of the textbook. The lab manual guides students through hands-on laboratory activities, provides training on industry-grade equipment and introduces students to conducting experiments while following current Good Manufacturing Practices. This …