Shoreline Biotech Experience Biomanufacturing Kit

Curriculum Description:

The Biomanufacturing kit scenario, from Shoreline Community College, provides a foundation in biomanufacturing regulations (FDA, GMP, quality systems), careers, and upstream process and downstream process. During this real product scenario, students work in teams for a fictional Contract Research Organization: Protein Purification Partners (PPP). All teams are made up of new hires at PPP who must be trained before beginning their first assignment - purification of Red Fluorescent Protein (RFP) or Green Fluorescent Protein (GFP). If desired, student team performance can be measured as teams compete to demonstrate to PPP that they are ready to take on production of an actual therapeutic. The curriculum is designed for students to work in teams of 4 or 5. Each team will be onboarded and undergo training in lab safety, Food and Drug Administration (FDA) Regulations including Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), and documentation. Each team member will be assigned a job and will familiarize themselves with their job description. The range of biomanufacturing positions will be discussed as a class as well. Once teams have been on-boarded and trained they will proceed through upstream and downstream processes to isolate purified RFP or GFP. This curriculum is designed to build on the Amgen Biotech Experience Labs 1-5 (RFP) or the BioRad pGlo Kit (GFP) both of which are already part of many high school biotech curricula.

Curriculum Contents:

The Biotech Experience Biomanufacturing Kit is divided into the following folders:

• Biomanufacturing Kit - A - Overview and Teacher Background
• Biomanufacturing Kit - B - Reagents Supplies and Equipment
• Biomanufacturing Kit - C - Module 1
• Biomanufacturing Kit - D - Module 2
• Biomanufacturing Kit - E - Module 3
• Biomanufacturing Kit - F - Curriculum Development Acknowledgments

Folder A includes a table of contents, kit organization and setup information for teachers, teacher links, and information about student prior skills and knowledge. The slide decks cover setup and biomanufacturing pathways. 

Folder B includes a table of contents; the column assembly protocol; a supplies and reagents list; a reagent sourcing, storage, and preparation guide, an equipment list; and a kit prep packing list. 

Folder C includes a table of contents and materials for Module 1 - New Hire Onboarding: Training, Regulations, Career Exploration. Materials include a syllabus, outline, teacher guides, lesson documents, an introduction to SOP, a SOP template, and more. 

The table of contents lists the lessons and related documents included for Module 1. Lessons include: Introduction to Biomanufacturing, New Hire Onboarding, New Hire Onboarding, New Hire Training (FDA, GMP), Job Assignments/Career Exploration, Standard Operating Procedure Training, and Documentation Forms.  

Folder D includes a table of contents and materials for Module 2: Upstream Process. Materials include a syllabus, outline, teacher guide, lesson documents, documentation forms, and more. 

The table of contents lists the lessons and related documents included for Module 2. Lessons include: Aseptic Technique, Bacterial Inoculation, Bacterial Culture Scale Up, Induction of Protein Production, and Bacterial Harvest. 

Folder E includes a table of contents and materials for Module 3: Downstream Process. Materials include a syllabus, outline, teacher guides, lesson documents, documentation forms, and more. 

The table of contents lists the lessons and related documents for Module 3. Lessons include: Bacterial Lysis, Protein Purification, Measuring Protein Concentration using the Bradford Assay (Standard Curve Samples), Measuring Protein Concentration of the Purified Protein, Graphing a Standard Curve, and Creating a Product Label. 

Folder F includes a document of acknowledgments. The acknowledgments list Shoreline College staff developers and other collaborators on this curriculum.

Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis.

SBE Biomanufacturing Kit_Curriculum (127 files, 21.8 MB)

• Biomanufacturing Kit - A - Overview and Teacher Background (7 files, 2.7 MB)
• Biomanufacturing Kit - B - Reagents Supplies and Equipment (7 files, 1.2 MB)
• Biomanufacturing Kit - C - Module 1 (42 files, 6.1 MB)
• Biomanufacturing Kit - D - Module 2 (38 files, 7.8 MB)
• Biomanufacturing Kit - E - Module 3 (30 files, 4 MB)
• Biomanufacturing Kit - F - Curriculum Development Acknowledgments (2 files, 45 KB)