Northeast Biomanufacturing Center and Collaborative

NBC2 Northeast Biomanufacturing Center and Collaborative National Science Foundation ATE Regional Center mission of NBC2: to coordinate local and regional efforts into a national biomanufacturing education and training system to promote, create, and sustain a qualified workforce 2005-2017 Extensive curriculum development, skill standards Professional Development for college faculty, students, HS teachers and HS students

National Regional Hubs Phase IV Big Pharma Hub Montgomery County Community College, Blue Bell, PA, Maggie Bryans P.I. Matt Marshall, Hetal Doshi Bucks County Community College, Newtown PA, Linda Rehfuss co-PI and co-Lead Cianna Cooper Upstate New York Hub Finger Lakes Community College, Canandaigua, NY, Jim Hewlett, co-PI Mid-Western Hub Ivy Tech Community College, Bloomington, IN, Sengyong Lee, co-PI Western Hub MiraCosta College, Oceanside, CA, Mike Fino, co-PI Southern Hub Alamance CC, Graham, NC, Bill Woodruff, co-PI

NBC2 Phase IV Goals Goal 1- Foster partnerships Goal 2-Provide an industry standard, cutting-edge curriculum Goal 3- Professional development - Protein is Cash HS teacher workshops - mini-BIOMAN workshops - High School Student BIOMAN Academies Goal 4- Collect and disseminate resources Goal 5- Sustain the work of NBC2 -

mini BIOMAN Conferences Stem cells in a regulated environment- Bill Woodruff, Alamance, NC, July 19-21, 2016 Single use technology- Bruce van Dyke, Quincy CC, 2017 Formulation, fill, and finish - Sengyong Lee, 2017 Upstream processing of CHO-Mabs- Maggie Bryans and Linda Rehfuss, 2017 Incorporating undergraduate research in QC and Process Development- Jim Hewlett, 2018 Downstream processing of Mabs- Lara Dowland, Mt. Wachusetts CC, 2018 Process development for Quality by Design- Mike Fino, 2018 Microalgae to Biodiesel- Danny Kainer, Lone Star CC, 2019 9th to be decided- emerging technology in Biomanufacturing, 2019

NBC2 Global Biomanufacturing Curriculum

NBC2 Textbook and Laboratory Manuals Pichia pastoris – HSA Core Production System CHO – tPA Core Production System Escherichia coli – GFP Core Production System Biomanufacturing Laboratory Manual, July 2009 Introduction to Biomanufacturing (textbook), December 2012 Protein is Cash Laboratory Manual Biomanufacturing Laboratory Manual (custom) Great Bay Community, Mount Wachusetts Community College and Montgomery County Community College This is the list of what we ‘own’ (published in Phase I or II). And here are copies of each one of these publications (distribute copies printed in Portsmouth). We will talk further about these when we get to Goal 5: Sustainability.

Global Biomanufacturing Curriculum Biomanufacturing Laboratory Manual - 2009 Metrology: SOPs for equipment Validation SOP for Market Forge Autoclave EH&S Program Quality Assurance: cGMP, SOPs, Batch Records, Equipment Logs Quality Control Microbiology SOPs Upstream Processing: E. coli recombinant for GFP Pichia pastoris recombinant for HAS CHO recombinant for tPA Downstream Processing: Purification of HSA from Pichia pastoris Purification of tPA from CHO Cell Culture Quality Control Biochemistry: SDS-PAGE, tPA and HSA ELISAs

Global Biomanufacturing Curriculum Introduction to Biomanufacturing textbook - 2012 CHAPTER 1 INTRODUCTION ENGINEERING UNIT OVERVIEW CHAPTER 2 FACILITIES CHAPTER 3 METROLOGY CHAPTER 4 VALIDATION CHAPTER 5 ENVIRONMENTAL, HEALTH, AND SAFETY (EHS) CHAPTER 6 OPERATIONAL EXCELLENCE QUALITY UNIT OVERVIEW CHAPTER 7 QUALITY ASSURANCE CHAPTER 8 MICROBIOLOGICAL CONTROL CHAPTER 9 QUALITY CONTROL BIOCHEMISTRY PRODUCTION UNIT OVERVIEW CHAPTER 10 UPSTREAM PROCESSING CHAPTER 11 DOWNSTREAM PROCESSING CHAPTER 12 PROCESS DEVELOPMENT APPENDIX A MASTER GLOSSARY

Textbook New Unit: Manufacture of Drug Product Unit Overview Authors- SMEs from Cook Pharmica and AB Biotech, Bloomington, IN Unit Overview Chapter 13: Formulation Development of Parenteral Products Chapter 14: Sterile Filtration, Filling and Lyophilization of Product Chapter 15: Inspection, Labelling and Packaging

Dissemination

www.biomanufacturing.org New biomanufacturing.org launched on February 29, 2016 Designed to be accessible, informative, engaging and user-friendly Provides easy access to all NBC2 materials which are now available for free - 200 SOPs, batch records, training documents - 15 textbook chapters and unit overviews - keynote lectures, videos, on-line learning modules - production manuals - biomanufacturing skill standards

The New www.biomanufacturing.org

miniBIOMAN Curriculum Modules www.biomanufacturing.org is where you will find all materials associated with each miniBIOMAN conference, curriculum modules containing: Lectures SOPs Materials list

Online Ancillary Curriculum Support A portal within the current website will be added August 2017 to serve biomanufacturing instructors with: PowerPoint presentations to accompany each chapter of the textbook an online support sheet for each chapter with links to active learning elements to engage the learner Test bank and Biomanufacturing exam SOP templates

Bioamanufacturing Skill Standards and Exam NBC2 Harmonized Skill Standards for Biomanufacturing, 2007 http://biomanufacturing.org/curriculum/resources/skill-standards 2013 validated and updated - Key Activities list Biomanufacturing exam developed based on these will be available August 2017