NBC2 Builds the Biomanufacturing
Infrastructure for the Bioeconomy
Sonia Wallman
Executive Director
NBC2
What is Biomanufacturing?
“Biomanufacturing… It is about 21st century advanced technology manufacturing inside
living cells”
-NSF Proposal 0903208
NBC2 Hub Partners
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Minuteman Regional High School, Lexington, MA
Finger Lakes Community College, Canandaigua, NY
Montgomery County Community College, Blue Bell, MD
Baltimore County Community College, Catonsville, MD
Alamance Community College, Graham, GA
Ivy Tech Community College, Bloomington, IN
Mira Costa College, Oceanside, CA
Community College - Biomanufacturer Partner:
Mount Wachusett Community College - BMS
http://www.nature.com/naturejobs/2009/090312/pdf/nj7235-246a.pdf
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Sought NBC2 help from the time there was talk that a biopharmaceutical biomanufacturer
was thinking of locating at Devens, MA (old military base).
Campus engineer and architect of the proposed biotechnology/biomanufacturing
laboratories to GBCC to view set-up for biotech research, development and
biomanufacturing.
Richard Elmer, Manager of Learning and Development at BMS , to GBCC to see
biotech/biomanufacturing facility and discuss NBC2 biomanufacturing hands-on curriculum.
Mount Wachusett adopted GBCC biotech/biomanufacturing facility set-up and equipment.
Once lab built, adopted NBC2 hands-on biomanufacturing curriculum for first
biomanufacturing class in Spring 2009.
Mount Wachusett is customizing the NBC2 hands-on laboratory curriculum for second
biomanufacturing class this Spring 2010.
NBC2 will publish the Mount Wachusett version of the NBC2 hands-on laboratory curriculum
at www.lulu.com
Mount Wachusett is helping NBC2 evaluate the online Virtual Chromatography Laboratory
curriculum to support the actual hands-on NBC2 Chromatography SOPs.
Importance of Industry Partners
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Advisory Board member
Provides understanding of local/global industry
Lectures in class and trouble shoots in lab
Provides tours, apprenticeships or internships
Donates plastic ware (including filters, test
tubes) and expired media, buffers, and reagents
 Provides help with curriculum development
 Participates in career fairs
 Provides finder fee for employing successful
student graduate
Curriculum
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Biomanufacturing Laboratory Manual
Introduction to Biomanufacturing textbook
Biofuels Production and Analysis textbook
Biofuels Laboratory Manual
Virtual laboratory and industrial scale
biomanufacturing modules
 Adult certificate course in biomanufacturing
 Protein is Cash laboratory manual
Biomanufacturing Laboratory Manual
 Generic
 Custom
 CHO – tPA
 Pichia pastoris - HSA
 Protein is Cash
GBC Generic Laboratory Manual
Metrology: SOPs for Equipment
Validation Protocols
EH&S Program
Quality Assurance: cGMP, SOPs, Batch
Records, Equipment Logs
Quality Control Microbiology SOPs
Upstream Processing SOPs:
E. coli recombinant for GFP, CHO recombinant
for tPA Cell Culture,
Pichia pastoris recombinant for HSA Cell
Culture
Downstream Processing SOPs: Purification of
human tPA from CHO Cell Culture
Purification of human serum albumin from
Pichia pastoris Cell Culture
Quality Control Biochemistry SOPs: SDSPAGE, tPA and HSA ELISAs
NBC2 Biomanufacturing
Laboratory Manual Adopters
• Mount Wachusett Community College (BMS is
biomanufacturer partner)
• Minuteman Regional High School Adult Evening
Program (Shire is biomanufacturer partner)
• Hudson Valley Community College (Regeneron is
biomanufacturer partner)
• Great Bay Community College (Lonza and Stryker are
biomanufacturer partners)
• Montgomery County Community College (Centocor)
• Hagerstown Community College (MedImmune)
Introduction to Biomanufacturing
• Authored by Industry
Experts
• 11 chapters
• Piloted in Spring 2011
• Industry interest
• Scheduled for release, fall
2011
Introduction to Biomanufacturing
Engineering
Quality
• Operational
Excellence
• Quality Assurance • Upstream Processing
Marti Mathews, Biogen Idec
• Facilities
Brian Shingle, Centocor
• Metrology
Gene Kernan, HGSI
• Validation
Patrick Sheehy, HGSI
• EH&S
John Piampiano, Kodak
Cynthia Sarnoski
Frank Hallinan, Pfizer
Ron Hudcosky, Merck
Production
Olga Mollin, Lonza
Jane Flanagan, Lonza
• Downstream
• Microbial Control
Processing
John Hasyn, MCCC
Paul O’Neil, Pall Euroflow
• QC Biochemistry • Process Development
Mary Harne, HGSI
Zhenhong Lee, HGSI
Ezster Birck Wilson
Biofuels Curricula
Biofuels Production and Analysis
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Introduction
Energy
Fuels
Gases
Molecules & Biomass
Enzymes
Photosynthesis and Algae
Biofuels
Biofuels Laboratory Manual
• Introduction to Biofuels
Production
• Using Cellulosic
Enzymes to Produce
Bioethanol
• Using Bacteria to
Produce Biohydrogen
• Using Algae to Produce
Biodiesel
Protein is Cash Laboratory Manual
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Metrology
Transformation
Upstream processing
Downstream processing
Qualitative analysis
Introduction to Cellulosic
Biofuels
Can be found at:
www.biomanonline.org
Biomanufacturing Certificate Course
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12 week course
Meeting 5 days a week
With a 6 hour lecture and lab each day
Mix of Protein is Cash and selected laboratoryscale SOPs from the generic laboratory
manual
 Virtual laboratory and industrial scale
biomanufacturing modules - blended learning
 Online lecture series is next step
Promoting Biomanufacturing Careers:
Biomanufacturing Apprenticeships
Joe was an apprentice at Lonza in the first
year of his Biotechnology Associate’s degree
from GBCC in 2008. With 12 credits
transferred in from college classes taken in
high school (Running Start), he graduated
early and worked at Lonza prior to attending
UMBC this Fall 2009.
http://www.atetv.org/watch-videos/episode.aspx?e=1443&c=1445
Protein is Cash
Adult Certificate Program (Details)
Week
Lecture
Laboratory Work
1
Intro to Biotech/Biomanufacturing & GMP
Documentation of Work
GMP Activities
Metrology : Introduction to
Precision and Accuracy
Balances, Micropipets
2
Upstream Processing: Basic Cell Structure
Microbes vs animal cells
Cell Growth
Sterile Techniques
Media Preparation (liquid and
plates)
Antibiotic sensitivity
3
Upstream Processing and Genetic Transformation Use of Balance and Autoclave
of DNA; Protein Characteristics
Validation of Sterilization
4
Upstream Processing : Cell Culture, Scale-Up,
Monitoring of Cell Growth, Harvest
Determination of Live Cell
Number and OD
week
lecture
Laboratory Work
5
Downstream Processing
Methods of Purification
Harvest and Centrifugation
TFF concentration of product
6
Solution Preparation and pH
Determinations
Salt and pH effect on proteins in solution;
Use of the pH meter
Preparation of buffer solutions
7-8
Purification of Product by
Chromatography Techniques
Size exclusion, hydrophobic interaction,
Ion exchange
9
Qualitative Analysis of Purity of
Product
PAGE analysis of product purity
ELISA /product identification
10
Documentation of Products by Batch
Records, Final Formulation
FDA and Drug Approval
Calculation of total yield of product
FDA review process for Drug Approval
11
Use of laboratory sized process
controlled bioreactor
Growth of cells in bioreactor
P.pastori s cell production of HSA
12
Use of laboratory sized
Process controlled LC
Use of LC process for automated
purification of HSA by Affinity
Virtual Chromatography –
The Power of Interactive Visualization in
Understanding a STEM Field of Study
 Understanding the physics, chemistry and biology of the
chromatographic system and the binding of the protein of
interest to the chromatographic matrix or beads (Science)
 Understanding the design and operation of chromatography
components and of the chromatographic process (Technology
and Engineering).
 Understanding the calculations needed to run
chromatographic system (column volume) and
measurements on chromatograms needed to calculate
HETP, number of theoretical plates, retention time,
resolution (Mathematics).
the
the
the
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Actual BioLogic System
• Complex System
• Not easy to ‘see’
interaction of components
• Students use virtual
system to prepare to use
actual system
• Use virtual system for
BIOMANonline
• System same as industrial
chromatography skid
Chromatography Skid – Components
Engineering and Advanced Technology
A screenshot of the Virtual Liquid Chromatography Laboratory.
3D images of major system components are delivered as you click on them.
Chromatography Skid – Controller
Engineering and Advanced Technology
The Virtual Liquid Chromatography Laboratory showing the interactive controller which
enables students to operate the system and set process parameters.
Chromatography Skid –
Chromatogram with Mathematics
The Virtual Chromatography Laboratory teaches students how to make calculations on
chromatograms such as the efficiency of column packing (HETP).
Chromatography Skid –
Chromatography Science and Technology
The Virtual Chromatography Laboratory showing the operation of the chromatography system during the
‘load’ phase, the chromatogram showing the flow through of proteins that do not attach to the
chromatographic matrix, and a nanoscale view inside the column of the affinity bead with the protein of
interest in the filtrate (green) attached and proteins not specific for the bead flowing through the column.
Chromatography Skid –
Chromatography Science and Technology
The Virtual Chromatography Laboratory showing the operation of the chromatography system
during the ‘elution’ phase, the chromatogram showing the beginning of the peak of the protein
of interest, and a nanoscale view inside the column of the affinity bead showing the protein of
interest detaching from the bead as the elution buffer (red) moves through the column.
Downstream Processing Equipment Similarities
Lab Scale
Chromatography System
Large Scale
Chromatography System
Access to Virtual Modules
http://ATeLearning.com/BioChrom/
Professional Development for
Faculty, Teachers and Students
 BIOMAN Annual Conference in July – July 2012
at Alamance CC in Graham, North Carolina
 Community College Program at BIO
International Annual Meeting – June 2012 in
Boston, Massachusetts
 Protein is Cash Teachers Workshops – now
scheduling for Spring and Summer 2012
BIOMAN
 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 in Blue Bell, PA;
BIOMAN 2009 in Rochester, NY;
2010 in Bloomington, IL; and 2011
in San Diego.
 BIOMAN features keynote lectures,
panels, hands-on workshops, a
vendor show and a tour of a
biomanufacturing facility.
Photo Bubble Bioreactor
BIOMAN 2012
BIOMAN 2012 in San Diego
Biohydrogen from Bacteria
Making tPA in CHO Cells
Protein is Cash
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Five Days/Five Topics
Metrology
Transformation and
Upstream Processing
Downstream Processing
(Chromatography)
Quality Control
Biochemistry
Cellulosic Biofuels
Laboratory
Online support at www.biomanonline.org
Protein is Cash
 Raise awareness about biomanufacturing by
presentation of Protein is Cash biomanufacturing
workshops throughout the alliances
 Increase and solidify relationships among community
colleges and high school teachers
 Provide biomanufacturing career path information via
education and industry presentations and tour
 Provide theory and hands-on curriculum for use by
teachers and an online support site at
www.biomanonline.org
Protein is Cash 2010
Total number = 103 teachers
Location
Date
Teachers Attending
Biotechnology Center URI
Providence, RI
March 6,13,20,27 & April 10
19
Hudson Valley CC
Albany, NY
March 22-25
23
Minuteman Career & Tech
HS
Lexington, MA
April 20-23
14
Hillsborough CC
Tampa, FL
June 14-18
29
Mesa CC
Mesa, Arizona
June 22-26
10
Great Bay CC
Portsmouth, NH
June 28-July 2
8
Protein is Cash 2010
Minuteman
Career and Technical HS
QC Biochemistry – SDS PAGE
Protein is Cash 2011
Total number = 71 teachers
Location
Hillsborough CC
Brandon, FL
Hudson Valley CC
Troy, NY
Houston CC
Houston, Texas
Middlesex CC
Edison, NJ
Blue Grass CTC
Lexington, KY
Middlesex CC
Lowell, MA
Date
Teachers Attending
March 19
12
March 21-24
16
June 13-17
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June 27- July 1
14
July 18-22
17
August 8-12
12
Protein is Cash 2011
GFP Column Chromatorgraphy
at Blue Grass CTC
Alltech Tour: The Future Farm
Nutritional Genomics
Website for Dissemination
www.biomanufacturing.org
Web Statistics
Helping You
 Visit the website
 Get in touch:
swallman@biomanufacturing.org
 Get in touch with a hub director in your region
(see folders for hubs)
 Attend BIOMAN, CCP at BIO or Bio-Link
 Sign up for a Protein is Cash Teachers
Workshop