Putting Biomanufacturing Putting Biomanufacturing into Your CurriculumSonia WallmanExecutive Director, NBC2January 13, 2012 – Bio‐Link Conference
NBC2 Helps pLearning 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 DevelopmentCapacity 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
Enhance, Expand and Use the NBC2 GBC E h E d d U thCurriculum in Response to Industry Needs
Global BioManufacturing Curriculum Virtual Labs
NBC2 Biomanufacturing Curricular Components Curricular ComponentsGBC Laboratory Manual generic and customizedGBC L b t M l i d t i dIntroduction to Biomanufacturing textbookBiofuels Production and Analysis textbook and lab manualProtein is Cash Teachers WorkshopBIOMAN Online Adult Certificate/Incumbent BIOMAN Online Adult Certificate/IncumbentWorker biopharmaceutical biomanufacturing course Future = more customization of curriculum to suit F t t i ti f i l t itlocal biomanufacturing needs
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
Introduction to Biomanufacturing Introduction to BiomanufacturingEngineering Quality Production• Operational • Quality Assurance • Upstream Processing Cynthia Sarnoski, Cynthia Sarnoski, Excellence E ll Frank Hallinan, Pfizer Olga Mollin, Lonza l lliMarti 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 EuroflowGene Kernan, HGSIGene Kernan HGSI • Process Development Process Development • QC Biochemistry• Validation Mary Harne, HGSI Ezster Birck WilsonPatrick Sheehy, HGSI Zhenhong Lee., HGSI• EH&SJohn Piampiano, Kodak
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
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
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
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
NBC2 Biofuels CurriculumPart of the EDGE (Educating and Developing New P f h EDGE (Ed i dD l i NWorkers for the Green Economy) program in San Diego.DiegoOne of several certificate courses offered at community colleges and universities in San Diegocommunity colleges and universities in San DiegoPiloted 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 Teachers Workshop Laboratory ManualT 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
Protein is Cash Workshops p2010 2011 2012Biotechnology Center URIBiotechnology Center URI Hillsborough CC Hillsborough CC Windward CC Windward CCProvidence, RI Brandon, FL Kaneohe, HIHudson Valley CC Hudson Valley CC Mount Wachusett CCAlbany, NYAlbany, NY Troy, NY Devens, MA Devens, MAMinuteman HS Houston CC LA Trade TechLexington, MA Houston, Texas Los Angeles, CAHillsborough CC Middlesex CC Middlesex CCTampa, FL Edison, NJ Edison, NJMesa CC Blue Grass CTC Middlesex CCMesa, AZ Lexington, KY Lowell, MAGreat Bay CC Middlesex CC Austin CCPortsmouth, NH Lowell, MA Austin, TX
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
Adult Biomanufacturing Certificate Program DetailsWeek Lecture Laboratory Work y1 Intro to Biotech/Biomanufacturing & GMP Documentation of work: GMP activity Metrology : Intro to precision and accuracy Balances, micropipets , pp2 Upstream Processing: Basic Cell Structure Sterile techniques Microbes versus animal cells Media preparation/ pouring Cell Growth plates Antibiotic sensitivity3 Upstream Processing and Genetic Transformation Autoclave validation of of DNA/ Protein Characteristics sterilization4 Upstream Processing : Scaling up of cells Determination of cell number Cell growth , crude isolation of product Use of spectrophotometer
Week Lecture Laboratory Work5 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 solutions7 ‐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 identification10 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 Approval11 Use of laboratory sized process Growth of cells in bioreactor controlled bioreactor P.pastori s cell production of HSA
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
Virtual Chromatography – The Power of Interactive Visualization in Understanding a STEM Fi ld f S d U d di STEM Field of StudyUnderstanding the physics chemistry and biology of the physics,chromatographic 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) Engineering).Understanding the calculations needed to run thechromatographic system (column volume) and themeasurements on chromatograms needed to calculate theHETP, number of theoretical plates, retention time, andresolution (M th l ti (Mathematics). ti )
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
Chromatography Skid – Components g g gyEngineering 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 g g Engineering and Advanced TechnologygyThe Virtual Liquid Chromatography Laboratory showing the interactive controller which enables students to operate the system and set process parameters.
Chromatography Skid – Chromatogram with Mathematics Chromatogram with MathematicsThe Virtual Chromatography Laboratory teaches students how to make calculations on chromatograms such as the efficiency of column packing (HETP).
Chromatography Skid – g p y gy Chromatography Science and TechnologyThe 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 – g p y gy Chromatography Science and TechnologyThe Virtual Chromatography Laboratory showing the operation of the chromatography systemduring h ‘elution’ hd 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 iof 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 Industrial Scale Chromatography System Ch t h S t Chromatography System Ch t h S t
The Virtual Chromatography Laboratory L b tUsed at MCCC, GBCC, MWCC, and FLCCUsed at MCCC GBCC MWCC and FLCC
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
Virtual BiomanufacturingFor 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 andTraining,Training Workforce Statistics and Career Pathways www.biomanufacturing.org www.biomanonline.org www.biomanufacturingcareers.org BIOMAN Group on LinkedIn
Build and Foster Local Partnerships Amongst Industry, Education and Organizations
Community College ‐ Biomanufacturer Partner: Mount Wachusett Community College Mount 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 and laboratories to GBCC to view set up for biotech research development andbiomanufacturing.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.comMount 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) ‐ LonzaLonza (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 BiotechnologyGBCC 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 Biomanufacturing Programs Bi f t i PMt. Wachusett Community College, MAQuincy College, MAHudson Valley Community College, NYHagerstown Community College, MDOnondaga Community College, NYOnondaga Community College NYSoCal Biomanufacturing Consortium
National Regional Alliances gMid-Western AllianceMid W t AlliIvy Tech Community College,Bloomington, INBl i tWestern AllianceMira Costa CollegeOceanside, CASouthern AllianceAlamance CCGraham, NC
Provide Professional Development for Provide Professional Development for Faculty, Students and Teachers
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
BIOMAN 2011 MiraCosta College, Oceanside, CA July 11‐14, 2011Focus on biofuels and biopharmaceuticalsThree tracks for biomanufacturing hands‐on workshops: advanced, Three tracks for biomanufacturing hands on workshops: advancedintermediate and beginnerKeynote 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 Biofuelsand 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, 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
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)
How to integrate biomanufacturing workforce development into your biotechnology curriculumdevelopment into your biotechnology curriculum1. 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. opportunities3. 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.
Biomanufacturing Course Development D l tChoose existing textbooks and laboratory manuals or make your own in a Course in a Box l k i C i Bapproach to providing your biomanufacturing students all they need to develop industrial t d t ll th dt d l i d t i lstrength skills, knowledge and attributes to succeed in this advance technology d i thi d t h lmanufacturing career path.
Individual Curriculum ModulesOver 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 Cash modules Online support site at www.biomanonline.org.
Course in a BoxThe NBC2 plan is to provide a ‘Course in a Box’ type of format to deliver the materials necessary ff d li h i lto run one SOP or a collection of SOPs. Two examples follow: l f ll 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 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
Cellulosic Biofuels Course in a Box Biofuels Laboratory 2: Using Cellulosic Enzymes to Produce Bioethanol Item Source Amount Cost SOP with Cover NBC2 20 each $ 5.00 Cellulosic Biofuels Kit Bio‐Rad 1 each $89.00 Equipment • Smart Spectrophotometer Bio‐Rad 1 each • Shaking Water Bath g Fisher 1 each