This textbook describes topics such as quality principles, the pioneers of quality and their philosophies, quality management systems, the Food and Drug Administration (FDA), the drug approval process, regulation of biologics, food, and other products, and FDA enforcement. Each of the ten chapters begins with objectives and ends with summary points. Additional links to explore …
Quality Assurance and Regulatory Affairs for the Biosciences (O’Grady, 2021) (CC BY)Read More »
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 …
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.
Various resource material includes kit instruction guides and classroom resources, which provide a good source of basic concepts. Copyrighted and not modifiable, but free to use and distribute in courses.
This resource was derived from Concepts of Biology by OpenStax but has not been updated since January 2020. It is described by the Open Textbook Library as follows: Given the broad definition of biotechnology applications and products, it is easy to see how there is enormous overlap within the fields of cellular biology, microbiology, chemistry, …
Biotechnology Foundations, 2nd Edition (O’Grady, 2013) – OpenStax (CC BY)Read More »
This material was created and copyrighted by Jack O’Grady. This material can be openly shared and printed. Please send comments, derivatives, or corrections to jack.ogrady@austincc.edu. The content of this material is compiled from various sources, which are all cited within, and may be copyright protected.
This well-organized lab manual is housed in LibreTexts and each of the 21 labs begins by listing goals and student learning outcomes. Each lab contains useful images and highlights important equations and examples. The laboratory topics include basic lab skills and topics such as safety, metrics & measurements, pipetting, microscopy, spectrophotometry, making buffers and measuring pH, DNA …
The protocols and instructor guide included in this lab manual are part of a semester-long Synthetic Biology undergraduate research course (CURE) designed by the authors. The lab presented in this manual is designed for a Genetics or Biotechnology class and has been used at both two-year and four-year institutions. Students are tasked with designing and …