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Putting BiomanufacturingPutting Biomanufacturing into Your Curriculum
Sonia WallmanExecutive Director, NBC2January 13, 2012 – Bio‐Link Conference
NBC2 Helpsp
G l 1 B ild d F L l P hi
Learning Communities
Goal 1: Build and Foster Local Partnerships Between Biomanufacturers, Educational Institutions and Organizations
Goal 2: Enhance Expand and Use the NBC2
Curriculum
Professional Development Goal 2: Enhance, Expand and Use the NBC2
Global Biomanufacturing Curriculum in Response to Biomanufacturers Needs
Goal 3: Provide Professional Development
p
Dissemination
ld Goal 3: Provide Professional Development Opportunities in Biomanufacturing for Faculty, Teachers and Students
Goal 4: Disseminate Information on
Capacity Building
SUSTAINABILITY
Biomanufacturing Education and Training, Workforce Statistics and Career Opportunities
Goal 5: Plan for Sustainability
E h E d d U th NBC2 GBCEnhance, Expand and Use the NBC2 GBC Curriculum in Response to Industry Needs
Global BioManufacturing Curriculum
Virtual Labs
NBC2 Biomanufacturing Curricular ComponentsCurricular Components
GBC L b t M l i d t i dGBC Laboratory Manual generic and customized
Introduction to Biomanufacturing textbook
Biofuels Production and Analysis textbook and lab manual
Protein is Cash Teachers Workshop
BIOMAN Online Adult Certificate/IncumbentBIOMAN Online Adult Certificate/Incumbent Worker biopharmaceutical biomanufacturing course
F t t i ti f i l t itFuture = more customization of curriculum to suit local biomanufacturing needs
Introduction to Biomanufacturing T tb kTextbook
A th d b i d t t• Authored by industry experts
• 11 chapters plus introduction
• Industry using textbook for• Industry using textbook for incumbent technician training
• Scheduled for release, springScheduled for release, spring 2012
Introduction to BiomanufacturingIntroduction to Biomanufacturing
Engineering• Operational
E ll
Production• Upstream Processingl lli
Quality• Quality AssuranceCynthia Sarnoski,Excellence
Marti Mathews, Biogen Idec
• Facilities
Olga Mollin, Lonza
Jane Flanagan, Lonza
• Downstream
Cynthia Sarnoski, Frank Hallinan, PfizerRon Hudcosky, Merck
Brian Shingle, Centocor
• MetrologyGene Kernan HGSI
ProcessingPaul O’Neil, Pall Euroflow
• Process Development
• Microbial ControlJohn Hasyn, MCCC
Gene Kernan, HGSI
• ValidationPatrick Sheehy, HGSI
• Process DevelopmentEzster Birck Wilson
• QC BiochemistryMary Harne, HGSIZhenhong Lee., HGSI
• EH&SJohn Piampiano, Kodak
Global Biomanufacturing Curriculum Biomanufacturing Laboratory ManualBiomanufacturing Laboratory Manual
CMetrology: SOPs for equipmentValidation ProtocolsEH&S ProgramQuality Assurance: cGMP, SOPs, Batch
dRecords, Equipment LogsQuality Control Microbiology SOPsUpstream Processing:
E coli recombinant for GFPE. coli recombinant for GFP, CHO recombinant for tPA,Pichia pastoris recombinant for HSA
Downstream Processing:Downstream Processing: Purification of tPA from CHO Cell CulturePurification of HSA from Pichia pastoris Cell Culture
Quality Control Biochemistry: SDS‐PAGE, tPA and HSA ELISAs
Biofuels Curricullum
GBC Biomanufacturing L b M l AdLaboratory Manual 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
Biofuels Production and Analysis T tb kTextbook
I t d ti• Introduction
• Energy
F l• Fuels
• Gases
• Molecules & Biomass
• Enzymes
• Photosynthesis and Algae
• Biofuels
Biofuels Laboratory Manualf y
• Introduction to Biofuels ProductionProduction
• Using Cellulosic Enzymes to Produce yBioethanol
• Using Bacteria to Produce Biohydrogen
• Using Algae to Produce Biodiesel
NBC2 Biofuels Curriculum
P f h EDGE (Ed i d D l i NPart of the EDGE (Educating and Developing New Workers for the Green Economy) program in San DiegoDiego.
One of several certificate courses offered at community colleges and universities in San Diegocommunity 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
Protein is Cash T h W k h L b t M lTeachers Workshop Laboratory Manual
Day One: Metrology
Day Two: Transformation and Upstream ProcessingDay Two: Transformation and Upstream Processing
Day Three: Downstream Processing
Day Four: Quality Control BiochemistryDay Four: Quality Control Biochemistry
Day Five: Cellulosic Biofuels
S t it t bi liSupport site at: www.biomanonline.org
Protein is Cash Workshopsp
2010 2011 2012
Biotechnology Center URI Hillsborough CC Windward CCBiotechnology Center URIProvidence, RI
Hillsborough CCBrandon, FL
Windward CCKaneohe, HI
Hudson Valley CCAlbany, NY
Hudson Valley CCTroy, NY
Mount Wachusett CCDevens, MAAlbany, NY Devens, MA
Minuteman HSLexington, MA
Houston CCHouston, Texas
LA Trade TechLos Angeles, CA
Hillsborough CC Middlesex CC Middlesex CCHillsborough CCTampa, FL Edison, NJ
Middlesex CCEdison, NJ
Mesa CCMesa, AZ
Blue Grass CTCLexington, KY
Middlesex CCLowell, MA
Great Bay CCPortsmouth, NH
Middlesex CCLowell, MA
Austin CCAustin, TX
Adult Biomanufacturing Certificate ProgramCertificate 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
Adult Biomanufacturing Certificate ProgramDetailsDetails
Week Lecture Laboratory Work y
1 Intro to Biotech/Biomanufacturing & GMP Documentation of work:GMP activityMetrology : Intro to precision and accuracyBalances, micropipets, p p
2 Upstream Processing: Basic Cell StructureMicrobes versus animal cells Cell Growth
Sterile techniquesMedia preparation/ pouring platesAntibiotic sensitivity
3 Upstream Processing and Genetic Transformation of DNA/ Protein Characteristics
Autoclave validation of sterilization
4 Upstream Processing : Scaling up of cellsCell growth , crude isolation of product
Determination of cell numberUse of spectrophotometer
Week Lecture Laboratory Work
5 Downstream Processing Homogenization and centrifugation : initial gMethods of PurificationMedia, Cell ConcentrationCrude Isolate
g gproduct separation TFF concentration of product solution
6 Solution Preparation and pH Determinations
Salt and pH effect on proteins in solutionUse of the pH meter Preparation of buffer solutions
7 ‐8 Purification of product by Chromatography Techniques
Size exclusion, hydrophobic interaction, Ionexchange
9 Quality Control Analysis of Purity of PAGE analysis of product purity9 Quality Control Analysis of Purity ofProduct
PAGE analysis of product purityELISA /product identification
10 Documentation of Products by Batch Records Final Formulation
Calculation of total yield of productFDA review process for Drug ApprovalRecords, Final Formulation
FDA and Drug ApprovalFDA review process for Drug Approval
11 Use of laboratory sized process controlled bioreactor
Growth of cells in bioreactorP.pastori s cell production of HSA
The Virtual Chromatography LaboratoryChromatography Laboratory
Virtual Laboratory ScaleVirtual Laboratory Scale Chromatography
NBC2 in partnership withNBC in partnership with
Yakov Cherner of ATe‐Learning, Incorporated
Virtual Chromatography –The Power of Interactive Visualization in U d di STEM Fi ld f S dUnderstanding a STEM Field of Study
Understanding the physics chemistry and biology of theUnderstanding the physics, chemistry and biology of thechromatographic system and the binding of the protein ofinterest to the chromatographic matrix or beads (Science)
Understanding the design and operation of chromatographycomponents and of the chromatographic process (Technologyand Engineering)and Engineering).
Understanding the calculations needed to run thechromatographic system (column volume) and thechromatographic system (column volume) and themeasurements on chromatograms needed to calculate theHETP, number of theoretical plates, retention time, and
l ti (M th ti )resolution (Mathematics).
Actual BioLogic Systemg y
• Complex System
• Not easy to ‘see’ interaction of components
• Students use virtual system to prepare to use actual system
U i t l t f• Use virtual system for BIOMANonline
• System same as industrial• System same as industrial chromatography skid
Chromatography Skid – ComponentsEngineering and Advanced Technologyg g gy
A screenshot of the Virtual Liquid Chromatography Laboratory. 3D images of major system components are delivered as you click on them.
Chromatography Skid – ControllerEngineering and Advanced Technologyg g gy
The Virtual Liquid Chromatography Laboratory showing the interactive controller whichenables students to operate the system and set process parameters.
Chromatography Skid –Chromatogram with MathematicsChromatogram 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 Technologyg p y gy
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 thechromatographic matrix, and a nanoscale view inside the column of the affinity bead with the protein ofinterest in the filtrate (green) attached and proteins not specific for the bead flowing through the column.
Chromatography Skid –Chromatography Science and Technologyg p y gy
The Virtual Chromatography Laboratory showing the operation of the chromatography systemd i h ‘ l i ’ h h h h i h b i i f h k f h iduring the ‘elution’ phase, the chromatogram showing the beginning of the peak of the proteinof interest, and a nanoscale view inside the column of the affinity bead showing the protein ofinterest detaching from the bead as the elution buffer (red) moves through the column.
Downstream Processing Equipment Similarities
Lab Scale Ch t h S t
Industrial Scale Ch t h S tChromatography System Chromatography System
The Virtual Chromatography L b tLaboratory
Used at MCCC GBCC MWCC and FLCCUsed at MCCC, GBCC, MWCC, and FLCC
Virtual Biopharmaceutical Productionp
NBC2 in partnership with
Yakov Cherner of ATe‐Learning IncorporatedYakov Cherner of ATe Learning, Incorporated
and Lonza Biologics, Portsmouth, NH
Virtual Biomanufacturing
For previews of NBC2’s virtual, industrial‐scale biomanufacturing facility and virtual laboratory‐scale Bio‐Rad BioLogic LP chromatography system used
to practice and assess biomanufacturing skills see preview at /www.atelearning.com/BioDemo (use the password, Bio‐Rad).
Disseminate Biomanufacturing Education and Training Workforce Statistics and Career PathwaysTraining, Workforce Statistics and Career Pathways
www.biomanufacturing.orgwww.biomanonline.org
www.biomanufacturingcareers.orgBIOMAN Group on LinkedIn
Month Sites KBytes Visits Pages Files Hits
February 2010 5137 32936942 6254 12063 24653 47189y
February 2011 5621 77978037 4749 10908 37576 72294
Build and Foster Local Partnerships Amongst Industry, Education and Organizations
Community College ‐ Biomanufacturer Partner:Mount Wachusett Community College ‐ BMSMount Wachusett Community College BMS
http://www.nature.com/naturejobs/2009/090312/pdf/nj7235-246a.pdfSought 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 andlaboratories 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.
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 abiotechnology associate in science degree and certificate programs in Biotechnology
GBCC provides skilled biomanufacturing technicians (in upstream and p g ( pdownsteam processing, quality control microbiology and biochemistry, validation, process development, quality assurance) and upskilling of incumbent technicians for Lonza and others.
Mentored Community College Bi f t i PBiomanufacturing Programs
Mt. Wachusett Community College, MA
Quincy College, MA
Hudson Valley Community College, NY
Hagerstown Community College, MD
Onondaga Community College NYOnondaga Community College, NY
SoCal Biomanufacturing Consortium
National Regional Alliancesg
Mid W t AlliMid-Western AllianceIvy Tech Community College, Bl i t INBloomington, INWestern Alliance Mira Costa CollegeOceanside, CASouthern AllianceAlamance CCGraham, NC
Provide Professional Development forProvide Professional Development for Faculty, Students and Teachers
BIOMAN 2010 Annual ConferenceJuly 12‐15, 2010
Ivy Tech Commmunity CollegeBloomington, Indiana
• 44 Participants• 4 High School teachers sponsored by NBC2g p y• 15 Hands‐on Biomanufacturing workshops• Industry tours – Cook Pharmica, Baxter Biopharma• Vendor showVendor show• Panel discussions• Keynote Speakers:
‐ Medical Devices Dr D Chadwick Cook MedicalMedical 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
BIOMAN 2011
MiraCosta College, Oceanside, CA
July 11‐14, 2011
Focus on biofuels and biopharmaceuticals
Three tracks for biomanufacturing hands on workshops: advancedThree 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 BiofuelsCenter 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 InstituteTours of Genentech, Life Technologies (Invitrogen) and the Salk Institute
BIOMAN 2012
July 23‐26, 2012Alamance Community CollegeAlamance 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
Sustainability
Plan for NBC2 Sustainability
Sale of Biomanufacturing Curriculum MaterialsSale of Biomanufacturing Curriculum Materials
‐ Textbooks and Laboratory Manuals
‐ Lab ManualsLab Manuals
‐ Virtual Industrial and Lab Scale Biomanufacturing Modules ‐Materials to support Biomanufacturing Modules
Annual Conference and Workshops
Certification of Biomanufacturing Technicians
501C3 A d b Ad i i i MCCC501C3 Approved by Administration at MCCC
Incorporate – May/June 2012
Adopt corporate by lawsAdopt corporate by‐laws
Apply for non‐profit status (within 27 months)
How to integrate biomanufacturing workforce development into your biotechnology curriculumdevelopment into your biotechnology curriculum
1. Partner with local biomanufacturers, educators at various levels and organizations (e.g. US DOL).
2 D l ( f lib l d STEM2. Develop program (sequence of liberal arts and STEM courses=STEAM); develop laboratory, computer, and lecture facilities; choose biomanufacturing courses or modules tofacilities; 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 S i F d ti Ad d T h l i l C t BiScience Foundation Advanced Technological Centers, Bio‐Link and NBC2, BIO, SIM and ASM.
Biomanufacturing Course D l tDevelopment
Choose existing textbooks and laboratory l k i C i Bmanuals or make your own in a Course in a Box
approach to providing your biomanufacturing t d t ll th d t d l i d t i lstudents all they need to develop industrial strength skills, knowledge and attributes to
d i thi d t h lsucceed in this advance technology manufacturing career path.
Individual Curriculum Modules
Over 75 biopharmaceutical biomanufacturing SOPs based on industry practices.
11 biopharmaceutical biomanufacturing chapters in textbook authored by industry.
8 biofuels chapters in textbook authored by Elmar Schmid, representing both industry and education.
4 biofuels labs based on industry practices.
5 Protein is Cashmodules
Online support site at www.biomanonline.org.
Course in a Box
The NBC2 plan is to provide a ‘Course in a Box’ f f d li h i ltype of format to deliver the materials necessary
to run one SOP or a collection of SOPs. Two l f llexamples follow:
Protein is Cash ‐ Day 3: Downstream Processing
Biofuels Laboratory 2: Using Cellulosic Enzymes to Produce Bioethanol
Protein is Cash Course in a Box
Protein is Cash ‐ Day 3: Downstream Processing
Item Source Amount CostSOP with Cover NBC2 20 each $ 5.00
GFP Chromatography Kit Bio‐Rad 1 each $89.00
EquipmentEquipment• Mini‐Centrifuge• Microtube rack• Eppendorf Tubes (2ml)
Bio‐RadNBC2NBC2
1 each10 each1 bag (150)
Supplies• E. coli ‐ GFP transformed 1 ml cryovial• AEX Columns• CEX Columns• IEX Equilibration Buffer• IEX Elution Buffer 1• IEX Elution Buffer 2• GFP Standard
y10 each10 each
10 mlGFP Standard• UV Pen Lights• Glass Hearts
10 ml10 each20 each $33.00
Virtual DownstreamProcessing Module
• CD• Thumb Drive• App• Subscription
Cellulosic Biofuels Course in a Box
Biofuels Laboratory 2: Using Cellulosic Enzymes to Produce Bioethanol
Item Source Amount CostSOP with Cover NBC2 20 each $ 5.00
Cellulosic Biofuels Kit Bio‐Rad 1 each $89.00
Equipment• Smart Spectrophotometer• Shaking Water Bath
Bio‐RadFisher
1 each1 eachg
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