Transcript The Northeast Biomanufacturing Center and Collaborative

The Northeast Biomanufacturing
Center and Collaborative 2005-2008
Goals
Deliverables
Key
Successes
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Organization of the Northeast
Biomanufacturing Center and
Collaborative
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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:
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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 Pennsylvania
Centocor - 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:
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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
Goal 2
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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
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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
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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:
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2nd Life Pilot Plant
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Root Cause Analysis Program
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UV-VIS Spectrophotometer
Method Validation Protocol
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Bioreactor Cleaning Validation
Protocol
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HPLC Process SOP
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HPLC Equipment SOP
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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
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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 CHOtPA Core Production System.
Soon to come will be the
Pichia pastoris-HSA Core
Production System.
Goal 3
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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
BIOMAN 2007
Goal 4
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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
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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