1. Northeast Biomanufacturing Center and Collaborative

2. 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
Extensive curriculum development, skill standards
Professional Development for college faculty, students, HS teachers and HS students

3. 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

4. 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 -

5. 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

6. NBC2 Global Biomanufacturing Curriculum

7. 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.

8. 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

9. 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

10. 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

11. Dissemination

12.
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

13. The New www.biomanufacturing.org

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

21. 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

22. Bioamanufacturing Skill Standards and Exam
NBC2 Harmonized Skill Standards for Biomanufacturing, 2007
2013 validated and updated - Key Activities list
Biomanufacturing exam developed based on these will be available August 2017