The Northeast Biomanufacturing Center and Collaborative 2005-2008 Goals Deliverables Key Successes
Organization of the Northeast Biomanufacturing Center and Collaborative • Sonia Wallman, Center Director at Great Bay College (NH, ME, VT) • Tom Burkett, BioCapitol (MD, VA, DE) Hub Director at CC of Baltimore County • Linda Rehfuss, BigPharma (PA, NJ) Hub Director at Montgomery County CC • James Hewlett, Upstate New York Hub Director at Finger Lakes CC • Josephine Pino, RI Hub Director at CC of Rhode Island • Mary Jane Kurtz, MetroCambridge/Boston (MA, CT) Hub Director at Minuteman Regional High School
Goals Goal 1: Establish Sustainable Learning Communities around Community College Hubs Goal 2: Develop Biomanufacturing Curricula and Instructional Materials Goal 3: Provide Professional Development Opportunities in Biomanufacturing for Faculty Goal 4: Collect and Disseminate Biomanufacturing Education and Training and Workforce Information Goal 5: Build Biomanufacturing Infrastructure Capacity and Self-Sufficiency
Goal 1: Biomanufacturer-Community College Partnerships: • Lonza Biologics – Great Bay College in New Hampshire • Stryker Biotech – Great Bay College in New Hampshire • Bristol-Myers Squibb - Mount Wachusetts Community College in Massachusetts • Shire Biopharmaceutical Corporation-Minuteman Regional High School in Massachusetts • Bristol-Myers Squibb - Finger Lakes Community College in New York • Northeast Biofuels – Finger Lakes Community College in New York • Tengion – Montgomery County Community College in PennsylvaniaCentocor - Montgomery County Community College in Pennsylvania • Merck - Montgomery County Community College in Pennsylvania • Human Genome Sciences, Inc – Community College of Baltimore County in Maryland
Development of the upstate NY biotech/biomanufacturing corridor: Industry and State Organizations
That includes community colleges and universities: Academic Collaborators
Bringing High Schools into Biomanufacturing: • the educational consortium in Rhode Island that is anchored by the URI-CCRI partnership and trains Rhode Island high school teachers in biotech/biomanufacturing • the use of NBC2 hands-on biomanufacturing modules in the DOL funded BioTeach program for high school teachers led by the Massachusetts Biotechnology Council • the establishment of a DOL biomanufacturing apprenticeship program at Great Bay that serves as an infrastructure pump for high school students to enter the Biotechnology Associate in Science degree program and a dual enrollment program that provides for seamless transfer to the College of Life Sciences and Agriculture at the University of New Hampshire • a high school biotech/biomanufacturing academy within Great Bay College in New Hampshire using NBC2 Introduction to Biomanufacturing and BTEC 220 starting Fall 2008
Goal 2 • cGMP Popcorn Exercise • Confined Space Entry Program • Hazard Communication Program • Bioreactor Vessel Sterilization Validation Protocol • Forward Flow Filter Integrity Test for TFF System Protocol • Scout Pro Balance Operation and Maintenance SOP • Scout Pro Balance Calibration SOP • Autoclave Monitoring SOP • Gilson Pipetman P-20 to P-1000 Operation and Maintenance SOP • Pipette Calibration P-20 to P1000 SOP • CHO Culture for tPA Production SOP • 100ml Spinner Flask SOP • Applikon Bioreactor SOP • CHO-tPA Upstream Process BATCH RECORD • Ion Exchange Chromatography of tPA SOP • BioLogic LP Chromatography System SOP • Protein A Chromatography of IgG SOP • Preparation of Protein A Chromatography Column SOP • Biologic LP Chromatography System Protein A Chromatography Programming SOP • Trypan Blue Assay SOP • SDS PAGE SOP • Xcell SureLock Mini-Cell Gel Box SOP
Goal 2 • tPA ELISA SOP • tPA Activity Assay SOP • Bio-Tek Elx808UI Automated Microplate Reader SOP • LAL Assay: Cambrex QCLL-1000 Endpoint Colorimetric, Microplate Method SOP • Bio-Tek Elx808UI Automated Microplate Reader SOP • Introduction to Biomanufacturing for High School Seniors/College Freshman BIOMAN 2008 Pilot: • 2nd Life Pilot Plant • Root Cause Analysis Program • UV-VIS Spectrophotometer Method Validation Protocol • Bioreactor Cleaning Validation Protocol • HPLC Process SOP • HPLC Equipment SOP • HSA Process Development Protocols
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting in Indianapolis in September 2007
Industry Suggestions from Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting in Indianapolis in September 2007 Focus on Production Jobs: Upstream and Downstream Processing Focus on Quality Control Jobs: QC Microbiology and QC Biochemistry There was also interest in a Maintenance/Instrumentation Job
Goal 2 • Our strategy has been to develop hands-on instructional materials to support ten biomanufacturing technician jobs. The modules will be bundled together to produce a laboratory manual covering all of the jobs to give an overview of biomanufacturing, but focusing on production and quality control. • The modules can be used as stand-alone short courses for incumbent technician and professional training or for faculty development at local and regional workshops and the national BIOMAN conference. • We will also be producing a textbook covering the background material and theoretical underpinnings of each of the jobs, written by our industry partners. • We will have ancillaries available to help faculty and teachers use the laboratory manual and textbook that can be used to immediately set up a biomanufacturing course in a community college, high school or university setting.
Goal 2 The GBC Core Production Systems contain the SOPs needed for the production and quality control of a biopharmaceutical. The illustration is of the CHO-tPA Core Production System. Soon to come will be the Pichia pastoris-HSA Core Production System.
Goal 3 • BIOMAN is the NBC2’s annual Biomanufacturing Conference. About 45 faculty, teachers, and technician from the US and Puerto Rico (and about 25 industry presenters) attended BIOMAN 2006 and 2007 in Portsmouth, NH. BIOMAN 2008 is in Blue Bell, PA from July 13 through 17. • BIOMAN features keynote lectures, panels, hands-on workshops, a vendor show and a tour of a biomanufacturing company. • BIOMAN keynote lectures are videotaped and can be found at www.biomanufacturing.org/gbc
Goal 4 • Locally, print, radio and television are used to disseminate information about the careers available in biomanufacturing and the availability of industrial biotechnology education and training at our campuses. • Regional and national scientific meetings and meetings of agencies such as the Department of Labor regional apprenticeship meetings and the national DOL and NSF ATE meetings. • Local (Hub) workshops and an annual regional/national BIOMAN conference. • The central means of dissemination is via the website at www.biomanufacturing.org.
Goal 5 • Laboratory Manual and Textbook for college level education and training for ten biomanufacturing technician jobs • Incumbent technician and professional training for local biomanufacturers • Possibility of accreditation of programs and certification of students