Open Educational Resources and Biotechnology

• Biotechnology (Zuk and Martin) – LibreTexts (CC BY)

  

• Biotechnology Foundations, 2nd Edition (O’Grady, 2013) – OpenStax (CC BY)

  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, and biomedical engineering. It is the goal of this textbook to provide foundational knowledge to begin building your biotechnology toolkit and enter an exciting career of making a difference through biotechnology.

  

• Ancillary resources for Biotechnology Foundations (O’Grady, 2019) – GoogleDocs (varied licenses)

  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.

  

• Lab Manual: Introduction to Biotechnology (Orange County Biotechnology Education Collaborative, 2019) LibreTexts (CC BY-NC, except as otherwise noted)

  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 and protein gel electrophoresis, PCR, ELISA, performing restriction enzyme digests and transformation, and Good Manufacturing Practices (GMP). This lab manual provides specific directions as to how students should organize their corresponding laboratory notebook and each lab asks students specific conclusion questions that they are supposed to answer in their lab notebook.

  

• Lab Manual: Synthetic Biology Protocols (Orange County Biotechnology Education Collaborative, 2021) – LibreTexts (CC BY)

  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 then engineering a biological device in a bacterium (E. coli) using standardized DNA parts called Bio-Bricks from the iGEM (www.iGEM.org) registry. The process of engineering the device requires iteration of standard molecular biology cloning techniques which are outlined in the lab manual, some including video protocols. Additionally, provided are recipes for reagents, a supply/resources list, and instructor recommendations. A series of faculty training videos were created to further help with the implementation of the SynBio CURE.

  

• Biotechnology (Maioli) (CC BY-SA)

  This WikiBooks textbook provides an outline of some of the major topics in biotechnology including the various fields of biotechnology, an introduction to the Code of Federal Regulations, laboratory notebooks and Standard Operating Procedures (SOP’S), upstream and downstream process development, and laboratory skills for a biotechnology technician. This textbook primarily consists of bulleted outlines rather than narrative text and would probably work better as an auxiliary resource for review rather than the main textbook assigned for a course.

  

Same as listed for C-ID 101 and 101BX, plus:

• Biomanufacturing Laboratory Manual (Northeast Biomanufacturing Center and Collaborative, 2012)(Copyrighted but freely available)

  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.

• Manufacturer Resources by Bio-Rad (Copyrighted but freely available)

  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.

  • Bio-Rad YouTube channel (Unclear what license exists, but YouTube channel allows downloads and clipping for editing material)
    This resource is ancillary material from the BIO-RAD YouTube channel, “BIO-Rad Explorer”. Many demonstrations for lab techniques as “how-to” videos. There is also a community of videos covering various biotechnology topics.

• Quality Assurance and Regulatory Affairs for the Biosciences (O’Grady, 2019) (CC BY) – LibreTexts

  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.

• US Food and Drug Administration resources (All information provided for public use.)

  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.

• Various, American Society for Quality (License varies)

  Some material is available as open access, including articles, case studies, standards, and resources. Submit reprint and use permission request.

• Introduction to Biomanufacturing (Maggie Bryans, Ph.D.) (Copyrighted but freely available)

  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 comprehensive textbook in biomanufacturing was written by industry subject matter experts. It contains 15 chapters is organized into five units: introduction to biomanufacturing, engineering, quality, production, and manufacture of a drug product. Request access to the affiliated Instructor’s Portal to gain access to PowerPoint presentations aligned with each textbook chapter, curriculum modules, a comprehensive biomanufacturing exam, and template Standard Operating Procedures (SOP’s).

• NBC2 Resources – Not Openly Licensed

  The Northeast Biomanufacturing Center and Collaborative (NBC2) is a National Science Foundation Advanced Technology Education regional center that has been in existence since 2005. Several NSF-funded texts have been made available by NBC2. The following resources are not openly licensed, but are freely available. The descriptions below are from the NBC2 website or the indicated resource’s site.

  • Introduction to Biomanufacturing This comprehensive textbook in biomanufacturing was written by industry subject matter experts. It contains 15 chapters is organized into five units: introduction to biomanufacturing, engineering, quality, production, and manufacture of a drug product. Request access to the affiliated Instructor’s Portal to gain access to PowerPoint presentations aligned with each textbook chapter, curriculum modules, a comprehensive biomanufacturing exam, and template Standard Operating Procedures (SOP’s).
  • NBC2 Biomanufacturing Laboratory Manual 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.
  • Production of Monoclonal Antibodies Laboratory Manual This lab manual accompanies the aforementioned Introduction to Biomanufacturing textbook and contains flow charts, SOP’s, batch records, and user guides to direct students through anti-IL-8 monoclonal antibodies from CHO cells. It includes upstream processes, quality control, downstream processes, and equipment related to the production and purification of anti-IL-8 monoclonal antibodies.
  • Escherichia coli – GFP Core Production Manual The E.coli-GFP Core Production System Manual contains Standard Operating Procedures for the batch culture of recombinant E.coli., as well as a complete batch record for the entire upstream process. In addition, a list of skills and knowledge required for an Upstream Process technician is included.
  • CHO Cell – tPA Core Production Manual  The CHO Cell tPA Core Production System Manual includes upstream processing (cell culture) Standard Operating Procedures (SOPs) with batch record, downstream processing (purification) SOPs with batch record, and quality control biochemistry SOPs, including SDS PAGE, tPA ELISA, and a tPA activity assay.
  • Pichia pastoris – HSA Core Production Manual by Northeast Biomanufacturing Center & Collaborative (NBC²) The Pichia pastoris Core Production System Manual includes upstream processing Standard Operating Procedures (SOPs) and batch record for the process controlled fed batch fermentation of recombinant Pichia pastoris. Downstream processing SOPs include tangential flow filtration and affinity chromatography using the Biologic LP system. Quality control SOPs and a competencies list for downstream process technicians are also included.

• Basics of Cell Culture: A student laboratory manual (Afshar, 2019) (License not specified)

  This lab manual is authored by a faculty member from City College of San Francisco and was originally a component of the Mammalian Cell Culture Course-in-a-Box website where an older version of this resource can be found. The website describes this resource as follows: This course, from City College San Francisco, teaches the techniques necessary to maintain mammalian cells in culture. The course includes a laboratory exercise using mouse embryonic stem cells (takes 3 weeks to complete). Laboratory exercises provide instruction in basic techniques of routine cell culture using common cell lines before progressing to the differentiation of mouse embryonic stem cells. Photographs and explanations of common equipment (laminar flow hood, inverted microscope, etc.) and reagents are provided. Laboratory exercises include the following: Basic Aseptic Technique; Media Preparation; Plating cells from frozen stock; Cell counting and plating; Survival assay (UV); Live Cell Identification; Transfection; Freezing cells; Stem cell differentiation. A student manual and an instructor manual are provided. The course is taught to high school students but the materials are also used for college students.

  

• Introduction to Biosystems Engineering (Holden et al., 2021) (CC BY)
  While not officially a biotechnology textbook, this open resource does discuss biomanufacturing, in particular agricultural and food processing and manufacturing.
• Chemical Process Dynamics and Controls (Woolf) (CC BY) – LibreTexts
  While not officially a biotechnology textbook, this open resource does discuss applications to biotechnology, particularly P&ID for bioreactor applications. This textbook is a student-contributed open-source text covering the materials used in a senior level controls course. The authors cover a variety of approaches to reduce or manage this uncertainty through the use of robust designs, dynamic systems theory, nonlinear dynamics, control theory, and statistics.
• Introduction to Industrial Engineering (Boardman) – LibreTexts
  While not officially a biotechnology textbook, this open resource does discuss applications to biotechnology, particularly Quality Control in (bio)manufacturing. This book was created for an undergraduate Introduction to Industrial Engineering course at The University of Texas at Arlington (UTA). The chapters give an overview of the profession and an introduction to some of the tools used by industrial engineers in industry. There are interactive content exercises included at the end of most chapters. This interactive content aims to engage students in the content as they are reading. The book will continue to revised and updated with new information as it becomes necessary. More interactive content will be added to the end of each chapter in future versions of the book.

• Virtual Labs for Biostatistics (Desharnais and Son, 2023) (CC BY-NC-SA) – Merlot
  This work is applicable to quality control and process monitoring in biomanufacturing and Batch Records. This is an e-portfolio describing a course redesign project where traditional computer-based labs were replaced by online virtual labs. Assessment was conducted comparing the traditional and online approaches. The e-portfolio contains links to the virtual labs used and the laboratory exercises.
• The Science and Business of Biotechnology (MIT Open Learning Library, 2021) (License not specified)
  No attribution provided, no authors provided. This course is archived on the MIT Open Learning Library with assignments and discussion forums inactivated. This course focuses on early-stage biotechnology companies, with particular emphasis on understanding the underlying science, technology, and disease targets—together with the application of novel business structures and financing methods—to facilitate drug discovery, clinical development, and greater patient access to new therapies.