Presentation6 bioman course in a box wallman

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