1. Putting Biomanufacturing
Putting Biomanufacturing
into Your Curriculum
Sonia Wallman
Executive Director, NBC2
January 13, 2012 – Bio‐Link Conference
2. NBC2 Helps
p
Learning Communities
Curriculum Goal 1: Build and Foster Local Partnerships
G l 1 B ild d F L lP hi
Between Biomanufacturers, Educational
Professional Institutions and Organizations
Development
p Goal 2: Enhance Expand and Use the NBC2
Goal 2: Enhance, Expand and Use the NBC
Global Biomanufacturing Curriculum in
Dissemination
Response to Biomanufacturers Needs
Goal 3: Provide Professional Development
Goal 3: Provide Professional Development
Capacity Building
ld
Opportunities in Biomanufacturing for
Faculty, Teachers and Students
SUSTAINABILITY
Goal 4: Disseminate Information on
Biomanufacturing Education and Training,
Workforce Statistics and Career
Opportunities
Goal 5: Plan for Sustainability
3. Enhance, Expand and Use the NBC2 GBC
E h E d d U th
Curriculum in Response to Industry Needs
5. NBC2 Biomanufacturing
Curricular Components
Curricular Components
GBC Laboratory Manual generic and customized
GBC L b t M l i d t i d
Introduction to Biomanufacturing textbook
Biofuels Production and Analysis textbook and lab
manual
Protein is Cash Teachers Workshop
BIOMAN Online Adult Certificate/Incumbent
BIOMAN Online Adult Certificate/Incumbent
Worker biopharmaceutical biomanufacturing course
Future = more customization of curriculum to suit
F t t i ti f i l t it
local biomanufacturing needs
6. Introduction to Biomanufacturing
Textbook
T tb k
• A th d b i d t
Authored by industry experts
t
• 11 chapters plus introduction
• Industry using textbook for
Industry using textbook for
incumbent technician training
• Scheduled for release, spring
Scheduled for release, spring
2012
7. Introduction to Biomanufacturing
Introduction to Biomanufacturing
Engineering Quality Production
• Operational • Quality Assurance • Upstream Processing
Cynthia Sarnoski,
Cynthia Sarnoski,
Excellence
E ll Frank Hallinan, Pfizer
Olga Mollin, Lonza
l lli
Marti Mathews, Biogen Idec Ron Hudcosky, Merck Jane Flanagan, Lonza
• Facilities • Downstream
Brian Shingle, Centocor • Microbial Control Processing
John Hasyn, MCCC
• Metrology Paul O’Neil, Pall Euroflow
Gene Kernan, HGSI
Gene Kernan HGSI • Process Development
Process Development
• QC Biochemistry
• Validation Mary Harne, HGSI Ezster Birck Wilson
Patrick Sheehy, HGSI Zhenhong Lee., HGSI
• EH&S
John Piampiano, Kodak
8. Global Biomanufacturing Curriculum
Biomanufacturing Laboratory Manual
Laboratory Manual
C
Metrology: SOPs for equipment
Validation Protocols
EH&S Program
Quality Assurance: cGMP, SOPs, Batch
Records, Equipment Logs
d
Quality Control Microbiology SOPs
Upstream Processing:
E. coli recombinant for GFP,
E coli recombinant for GFP
CHO recombinant for tPA,
Pichia pastoris recombinant for HSA
Downstream Processing:
Downstream Processing:
Purification of tPA from CHO Cell Culture
Purification of HSA from Pichia pastoris Cell
Culture
Quality Control Biochemistry: SDS‐PAGE, tPA
and HSA ELISAs
10. GBC Biomanufacturing
Laboratory Manual Ad
L b M l Adopters
• Mount Wachusett Community College, MA (BMS is
y g (
biomanufacturer partner)
• Minuteman Regional High School Adult Evening
Program, MA (Shire is biomanufacturer partner)
( )
• Hudson Valley Community College, NY (Regeneron is
biomanufacturer partner)
biomanufacturer partner)
• Great Bay Community College, NH (Lonza is
biomanufacturer partner)
p )
• Montgomery and Bucks County Community Colleges, PA
• Hagerstown Community College, MD
• Community Colleges, southern CA
11. Biofuels Production and Analysis
Textbook
T tb k
• Introduction
I t d ti
• Energy
• Fuels
F l
• Gases
• Molecules & Biomass
• Enzymes
• Photosynthesis and Algae
• Biofuels
12. Biofuels Laboratory Manual
f y
• Introduction to Biofuels
Production
• Using Cellulosic
Enzymes to Produce
y
Bioethanol
• Using Bacteria to
Produce Biohydrogen
• Using Algae to Produce
Biodiesel
13. NBC2 Biofuels Curriculum
Part of the EDGE (Educating and Developing New
P f h EDGE (Ed i dD l i N
Workers for the Green Economy) program in San
Diego.
Diego
One of several certificate courses offered at
community colleges and universities in San Diego
community colleges and universities in San Diego
Piloted at MiraCosta College in 2011 and University
of Hawaii Hilo in 2012.
of Hawaii – Hilo in 2012.
Support site under development at
www.biomanonline.com
15. Protein is Cash
Teachers Workshop Laboratory Manual
T h W kh L b t M l
Day One: Metrology
Day Two: Transformation and Upstream Processing
Day Two: Transformation and Upstream Processing
Day Three: Downstream Processing
Day Four: Quality Control Biochemistry
Day Four: Quality Control Biochemistry
Day Five: Cellulosic Biofuels
Support site at: www.biomanonline.org
S t it t bi li
16. Protein is Cash Workshops
p
2010 2011 2012
Biotechnology Center URI
Biotechnology Center URI Hillsborough CC
Hillsborough CC Windward CC
Windward CC
Providence, RI Brandon, FL Kaneohe, HI
Hudson Valley CC Hudson Valley CC Mount Wachusett CC
Albany, NY
Albany, NY Troy, NY Devens, MA
Devens, MA
Minuteman HS Houston CC LA Trade Tech
Lexington, MA Houston, Texas Los Angeles, CA
Hillsborough CC Middlesex CC Middlesex CC
Tampa, FL Edison, NJ Edison, NJ
Mesa CC Blue Grass CTC Middlesex CC
Mesa, AZ Lexington, KY Lowell, MA
Great Bay CC Middlesex CC Austin CC
Portsmouth, NH Lowell, MA Austin, TX
17. Adult Biomanufacturing
Certificate Program
Certificate Program
Derived from Protein is Cash and the
Global Biomanufacturing Curriculum
• 12 week course comes with online lectures
• 6 hours of hands‐on activities with lecture
6 hours of hands‐on activities with lecture
per day
• Total of 360 hours for Biomanufacturing Certificate
• Focuses on putting people to work immediately
• Version piloted at global bioman company in 2009
18. Adult Biomanufacturing Certificate Program
Details
Week Lecture Laboratory Work
y
1 Intro to Biotech/Biomanufacturing & GMP Documentation of work:
GMP activity
Metrology : Intro to precision
and accuracy
Balances, micropipets
, pp
2 Upstream Processing: Basic Cell Structure Sterile techniques
Microbes versus animal cells Media preparation/ pouring
Cell Growth plates
Antibiotic sensitivity
3 Upstream Processing and Genetic Transformation Autoclave validation of
of DNA/ Protein Characteristics sterilization
4 Upstream Processing : Scaling up of cells Determination of cell number
Cell growth , crude isolation of product Use of spectrophotometer
19. Week Lecture Laboratory Work
5 Downstream Processing g Homogenization and centrifugation : initial
g g
Methods of Purification product separation
Media, Cell Concentration TFF concentration of product solution
Crude Isolate
6 Solution Preparation and pH Salt and pH effect on proteins in solution
Determinations Use of the pH meter
Preparation of buffer solutions
7 ‐8 Purification of product by Size exclusion, hydrophobic interaction, Ion
Chromatography Techniques exchange
9 Quality Control Analysis of Purity of
Quality Control Analysis of Purity of PAGE analysis of product purity
PAGE analysis of product purity
Product ELISA /product identification
10 Documentation of Products by Batch Calculation of total yield of product
Records, Final Formulation
Records Final Formulation FDA review process for Drug Approval
FDA review process for Drug Approval
FDA and Drug Approval
11 Use of laboratory sized process Growth of cells in bioreactor
controlled bioreactor P.pastori s cell production of HSA
20. The Virtual
Chromatography Laboratory
Chromatography Laboratory
Virtual Laboratory Scale
Virtual Laboratory Scale
Chromatography
NBC2 in partnership with
in partnership with
Yakov Cherner of ATe‐Learning, Incorporated
21. Virtual Chromatography –
The Power of Interactive Visualization in
Understanding a STEM Fi ld f S d
U d di STEM Field of Study
Understanding the physics chemistry and biology of the
physics,
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)
Engineering).
Understanding the calculations needed to run the
chromatographic system (column volume) and the
measurements on chromatograms needed to calculate the
HETP, number of theoretical plates, retention time, and
resolution (M th
l ti (Mathematics).
ti )
22. Actual BioLogic System
g y
• Complex System
• Not easy to ‘see’
interaction of components
• Students use virtual
system to prepare to use
actual system
•UUse virtual system for
it l t f
BIOMANonline
• System same as industrial
System same as industrial
chromatography skid
23. Chromatography Skid – Components
g g gy
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.
24. Chromatography Skid – Controller
g g
Engineering and Advanced Technologygy
The Virtual Liquid Chromatography Laboratory showing the interactive controller which
enables students to operate the system and set process parameters.
25. Chromatography Skid –
Chromatogram with Mathematics
Chromatogram with Mathematics
The Virtual Chromatography Laboratory teaches students how to make calculations on
chromatograms such as the efficiency of column packing (HETP).
26. Chromatography Skid –
g p y gy
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.
27. Chromatography Skid –
g p y gy
Chromatography Science and Technology
The Virtual Chromatography Laboratory showing the operation of the chromatography system
during h ‘elution’ h
d i the ‘ l i ’ phase, the chromatogram showing the b i i of the peak of the protein
h h h i h beginning f h k f h i
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.
29. The Virtual Chromatography
Laboratory
L b t
Used at MCCC, GBCC, MWCC, and FLCC
Used at MCCC GBCC MWCC and FLCC
30. Virtual Biopharmaceutical Production
p
NBC2 in partnership with
Yakov Cherner of ATe Learning, Incorporated
Yakov Cherner of ATe‐Learning Incorporated
and Lonza Biologics, Portsmouth, NH
40. Disseminate Biomanufacturing Education and
Training,
Training Workforce Statistics and Career Pathways
www.biomanufacturing.org
www.biomanonline.org
www.biomanufacturingcareers.org
BIOMAN Group on LinkedIn
41. Month Sites KBytes Visits Pages Files Hits
y
February 2010 5137 32936942 6254 12063 24653 47189
February 2011 5621 77978037 4749 10908 37576 72294
42. Build and Foster Local Partnerships Amongst
Industry, Education and Organizations
43. Community College ‐ Biomanufacturer Partner:
Mount Wachusett Community College
Mount Wachusett Community College ‐ BMS
http://www.nature.com/naturejobs/2009/090312/pdf/nj7235-246a.pdf
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
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.
biotech/biomanufacturing facility and discuss NBC 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.
44. Community College ‐ Biomanufacturer Partner:
NH Community Technical College (GBCC) ‐ Lonza
Lonza (earlier, Celltech Biologics) provides help with devlopment of
curriculum, including and o.j.t. in the apprenticeship program
GBCC provides training in biotechnology and biomanufacturing in a
p o des a g b o ec o ogy a d b o a u ac u g a
biotechnology associate in science degree and certificate programs in
Biotechnology
GBCC provides skilled biomanufacturing technicians (in upstream and
p g ( p
downsteam processing, quality control microbiology and biochemistry,
validation, process development, quality assurance) and upskilling of
incumbent technicians for Lonza and others.
45. Mentored Community College
Biomanufacturing Programs
Bi f t i P
Mt. Wachusett Community College, MA
Quincy College, MA
Hudson Valley Community College, NY
Hagerstown Community College, MD
Onondaga Community College, NY
Onondaga Community College NY
SoCal Biomanufacturing Consortium
46. National Regional Alliances
g
Mid-Western Alliance
Mid W t Alli
Ivy Tech Community College,
Bloomington, IN
Bl i t
Western Alliance
Mira Costa College
Oceanside, CA
Southern Alliance
Alamance CC
Graham, NC
48. BIOMAN 2010 Annual Conference
July 12‐15, 2010
Ivy Tech Commmunity College
Bloomington, Indiana
• 44 Participants
• 4 High School teachers sponsored by NBC2
g p y
• 15 Hands‐on Biomanufacturing workshops
• Industry tours – Cook Pharmica, Baxter Biopharma
• Vendor show
Vendor show
• Panel discussions
• Keynote Speakers:
‐ Medical Devices Dr D Chadwick Cook Medical
Medical Devices, Dr. D. Chadwick, Cook Medical
‐ Lyophilization in Biotechnology, Dr. M. Akers,
Baxter BioPharma Solutions
‐ Cell line Development in Biomanufacturing Dr A
Cell line Development in Biomanufacturing, Dr. A.
Pilling, Cook Pharmica
49. BIOMAN 2011
MiraCosta College, Oceanside, CA
July 11‐14, 2011
Focus on biofuels and biopharmaceuticals
Three tracks for biomanufacturing hands‐on workshops: advanced,
Three tracks for biomanufacturing hands on workshops: advanced
intermediate and beginner
Keynote Speakers include Stephen Mayfield, PhD, from UCSD and San Diego
Center for Algae Biotechnology on Microalgae for the Production of Biofuels
Center for Algae Biotechnology on ‘Microalgae for the Production of Biofuels
and other Bioproducts’ and Lee Landeen, PhD, from Advanced BioHealing on
‘Engineered Tissues for Wound Healing Applications’
Tours of Genentech, Life Technologies (Invitrogen) and the Salk Institute
Tours of Genentech Life Technologies (Invitrogen) and the Salk Institute
50. BIOMAN 2012
July 23‐26, 2012
Alamance Community College
Alamance Community College
Graham, North Carolina
• Focus on regenerative medicine: stem cell production, production of
replacement organs
• 13 Hands‐on Biomanufacturing workshops
• Industry tours – BiogenIdec, Tengion, Wakeforest Regenerative
Medicine Center
• Vendor show
• Panel discussions: How to Add Biomanufacturing to your Programs;
Overview of NSF ATE and other Funding Opportunities for supporting
Biomanufacturing Education, Training and the Workforce
• Keynote Speakers:
y p
‐ Regenerative Medicine, Dr. Anthony Atala, WFIRM, Winston‐Salem, NC
52. Plan for NBC2 Sustainability
Sale of Biomanufacturing Curriculum Materials
Sale of Biomanufacturing Curriculum Materials
‐ Textbooks and Laboratory Manuals
‐ Lab Manuals
Lab Manuals
‐ Virtual Industrial and Lab Scale Biomanufacturing Modules
‐ Materials to support Biomanufacturing Modules
Annual Conference and Workshops
Certification of Biomanufacturing Technicians
501C3 Approved by Administration at MCCC
501C3 A d b Ad i i i MCCC
Incorporate – May/June 2012
Adopt corporate by‐laws
Adopt corporate by laws
Apply for non‐profit status (within 27 months)
53. How to integrate biomanufacturing workforce
development into your biotechnology curriculum
development into your biotechnology curriculum
1. Partner with local biomanufacturers, educators at various
levels and organizations (e.g. US DOL).
2. Develop program (sequence of liberal arts and STEM
2 D l ( f lib l d STEM
courses=STEAM); develop laboratory, computer, and lecture
facilities; choose biomanufacturing courses or modules to
facilities; choose biomanufacturing courses or modules to
fit local partner needs; and develop o.j.t. opportunities
3. Provide opportunities for faculty, teacher and student
professional development.
4. Partner with national organizations such as the National
Science Foundation Advanced Technological Centers, Bio‐
S i F d ti Ad dT h l i lC t Bi
Link and NBC2, BIO, SIM and ASM.
54. Biomanufacturing Course
Development
D l t
Choose existing textbooks and laboratory
manuals or make your own in a Course in a Box
l k i C i B
approach to providing your biomanufacturing
students all they need to develop industrial
t d t ll th dt d l i d t i l
strength skills, knowledge and attributes to
succeed in this advance technology
d i thi d t h l
manufacturing career path.
57. Protein is Cash Course in a Box
Protein is Cash ‐ Day 3: Downstream Processing
Item Source Amount Cost
SOP with Cover NBC2 20 each $ 5.00
GFP Chromatography Kit Bio‐Rad 1 each $89.00
Equipment
• Mini‐Centrifuge Bio‐Rad 1 each
• Microtube rack NBC2 10 each
• Eppendorf Tubes (2ml) NBC2 1 bag (150)
Supplies
• E. coli ‐ GFP transformed 1 ml cryovial
y
• AEX Columns 10 each
• CEX Columns 10 each
• IEX Equilibration Buffer
• IEX Elution Buffer 1
• IEX Elution Buffer 2
• GFP Standard
GFP Standard 10 ml
10 ml
• UV Pen Lights 10 each
• Glass Hearts 20 each $33.00
Virtual Downstream
Processing Module
• CD
• Thumb Drive
• App
• Subscription