The Northeast Biomanufacturing Center and Collaborative 20052008

1
The Northeast Biomanufacturing Center and
Collaborative 2005-2008

• Goals
• Deliverables
• Key Successes

2
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

3
(No Transcript)
4
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
5
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

6
Development of the upstate NY biotech/biomanufactu
ring corridor
Industry and State Organizations
7
That includes community colleges and universities
Academic Collaborators
8
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

9
(No Transcript)
10
Goal 2
11
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

12
Goal 2

• 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

• 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

13
Harmonization of Biopharmaceutical Manufacturing
Skill Standards Meeting in Indianapolis in
September 2007
14
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

15
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.

16
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.

17
Goal 3

• BIOMAN is the NBC2s 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

18
BIOMAN 2007
19
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.

20
(No Transcript)
21
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