From Local to Regional to Global: Building the Biomanufacturing Infrastructure

1. From Local to Regional to Global:Building the Biomanufacturing Infrastructure

2. History Began Industrial Biotechnology program with 1994 NSF ATE grant for Equipment in return for Discovery Research Protocols and Biomanufacturing Standard Operating Procedures (SOPs) Created two 192 hour hands-on with theory courses that cover Industrial Biotechnology Discovery Research Biomanufacturing

3. Cornerstone Courses Biotechnology Certificate and Associate in Science Degree Discovery Research-GLP Restriction Enzyme Digest DNA Fingerprinting PCR Southern Blot Plasmid Engineering Transformation Cell Culture Protein Purification Western Blot cDNA Library Construction DNA Sequencing Biomanufacturing-cGMP E. coli Cell Culture CHO Cell Culture Pichia pastoris Cell Culture Purification of human tPA from CHO Cell Culture Purification of human serum albumin from P. pastoris Cell Culture Quality Control Microbiology and Biochemistry Quality Assurance Batch Records

4. Cornerstone Courses Education and training takes place in a facility that mimics an integrated Industrial Biotechnology company (a Virtual WorkplaceTM) with a Discovery Research Wet Lab, a Core Facility that doubles as a space for Media and Buffer preparation, and a Biomanufacturing Suite with Production, Quality and Support (Metrology, Validation, Environmental Health and Safety, Facilities and Process Development) functions. We use the tools, processes and regulatory structure of Industrial Biotechnology.

8. Early Student Success Linked to Biomanufacturing Jobs Lonza Biologics Wyeth Biopharma Marine Polymer Technologies Upstream Processing, Downstream Processing, Validation, Quality Control Biochemistry, Quality Control Microbiology, Quality Assurance, and Process Development

9. Student Profile 1994-2008 Graduates=384 Graduates at Work=305 Graduates at biomanufacturing companies=212 Companies employing biomanufacturing graduates: Lonza-NH, Wyeth-MA, Superior Controls-NH, Amgen-RI Amgen-CA, Genzyme-Alston-MA, Marine Polymer Technologies-MA, TKT(Shire)-MA, Arqule-MA, Bioprocessing-ME, IDEXX-ME, Bio-Concept-NH, East Coast Validation-NH, Roche-NJ, Formatech-MA, Beckton-Dickinson-MA, Igenex-CA, Repligen-MA, Hyaluron-MA, Alerchek-NH, GlycoFi-NH, Genentech-CA, Valicor-MA, Dakota Systems-MA, Stryker-NH, Adimab-NH, EMD-MA, Parsons-MA, Millennium-MA, BiogenIdec-MA, Millipore-NH, Cell Signaling-MA, Companies providing Biomanufacturing Apprenticeships: Lonza-NH, Bentley Pharmaceuticals-NH, NH BET Center-NH

10. Biopharmaceutical Manufacturing Skill Standards Worked with biomanufacturing company personnel in the Northeast to determine and validate the skills, knowledge and attributes needed for ten biomanufacturing jobs (process development, validation, metrology, upstream processing, downstream processing, quality control microbiology, quality control biochemistry, quality assurance, facilities, environmental health and safety) Skill Standards published January 31, 2005 Used as a basis for curriculum development; for a better understanding of the biopharmaceutical manufacturing sector; to catalyze the development of a biomanufacturing education, training and workforce infrastructure; and for the development of competency based biomanufacturing apprenticeships

11. Northeast Shows Sharp Increase in Biomanufacturing Three mature biotechnology clusters in the Northeast with many biomanufacturers: the earliest cluster in Massachusetts; the BigPharma cluster in Pennsylvania and New Jersey; the BioCapital cluster in Maryland, Delaware, Virginia, and D.C. Increase in new and expansion of old biomanufacturing facilities throughout the Northeast (http://www.biomanufacturing.org/jobboard.php) Over 50% of biomanufacturing workforce are technicians in the ten targeted jobs

12. The Northeast Biomanufacturing Center and Collaborative (NBC2) An NSF ATE Regional Manufacturing Center (for Biopharmaceutical Manufacturing) funded 9/1/2005 The Collaborative spans 12 states (6 New England states, NY, NJ, PA, DE, MD, VA) and the District of Columbia The Center is located at GBCC (NHCTC) in Portsmouth, NH Mission is to build the biomanufacturing education training and workforce infrastructure by working with biomanufacturing companies, educators and other organizations on building a global biomanufacturing curriculum and sustainable collaborative relationships Activities of the NBC2 include building a comprehensive curriculum for Biomanufacturing education and training, holding an annual conference (BIOMAN) for Biomanufacturing educators for a week each summer, and regionalizing a Biomanufacturing Apprenticeship program.

13. six Hubs in twelve northeastern states working with biomanufacturers on instructional materials to support education and training for ten targeted biomanufacturing technician jobs CCBC, Baltimore, MD: Validation and QA MCCC, Blue Bell, PA: QC Microbiology and Biochemistry CCRI, Warwick, RI: Up/Downstream Processing FLCC, Canandaigua, NY: Environmental Health and Safety NHCTC, Portsmouth, NH: Facilities, Metrology, Process Development MTHS, Lexington, MA: Introduction to Biomanufacturing

14. Northeast Biomanufacturers include many Global Companies Lonza Biologics Eli Lilly Wyeth Biopharma Amgen Bristol-Myers Squibb GlaxoSmithKline Genzyme Biogen Idec Shire MedImmune Centocor Abbott

16. Clusters of biopharmaceutical manufacturers throughout nation and globe. Educators supporting these companies are hungry for curriculum, instructional materials, and networking. North Carolina – six community colleges focusing on biomanufacturing (Alamance Community College is lead) California - San Diego and San Francisco areas (MiraCosta in Oceanside is the lead) Indiana – six community colleges focusing on biomanufacturing (Ivy Tech Community College at Bloomington and Indianapolis are leads) Ireland – FAS Biopharma (technical institute with GBCC partnership at Carrigaline in Cork County, Ireland) Puerto Rico – UPR Arecibo (Associate Degree program)

17. Global Biomanufacturing Curriculum Global biomanufacturers are working with the NBC2 to develop curriculum and instructional materials for ten targeted jobs (also working on, partnerships with global companies around student biomanufacturing apprenticeships, faculty experiences in industry, and incumbent technician training) In order to facilitate the development of new technician training programs and incumbent technician training short courses, the NBC2 is spearheading the development of a global biomanufacturing curriculum (GBC)

18. Harmonization of Skill Standards Three day meeting of industry leaders and educators in Indianapolis in September 2007 harmonized many existing skill standards into one global standard. Harmonized skill standards cover all jobs, focusing on production (upstream and downstream processing) and quality control (microbiology and biochemistry) Meeting documented and global skill standards published on www.biomanufacturing.com. Article on meeting available at www.bio-link.org/pdf/1007.pdf.

20. Based on Harmonized Global Skill Standards. Allows existing and new biotechnology programs to easily add a biomanufacturing focus. On-line at the NBC2 website at www.biomanufacturing.org. NBC2 membership (free) allows instructors to use or deposit curriculum and instructional materials to the on-line GBC repository. New materials will be identified and can be piloted at BIOMAN and participating institutions. 2009 publication of lab manual, industry written textbook and ancillaries covering ten targeted biomanufacturing jobs.

21. NBC2 Global Biomanufacturing Curriculum

22. Core Production System-CHO-tPA

24. New Initiatives Custom course design and publication for faculty training entry level and replacement technicians. Development of short courses for incumbent technician training offered by the NBC2’s National Biomanufacturing Institute (NBI). Experiences in large scale biopharmaceutical manufacturing (apprenticeships, internships, QMLC). Construction of a commercial biopharmaceutical manufacturing facility on 2nd Life and virtual large-scale equipment manipulation using videos and gaming technology (Immersive Learning Systems). Student exchange between FAS Biopharma Training Center in Carrigaline (large-scale) and GBCC in Portsmouth (lab-scale).