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Putting Biomanufacturing 
               Putting Biomanufacturing
                 into Your Curriculum
Sonia Wallman
Executive Director, NBC2
January 13, 2012 – Bio‐Link Conference
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 
Enhance, Expand and Use the NBC2 GBC
 E h      E     d d U th
Curriculum in Response to Industry Needs
Global BioManufacturing Curriculum




             Virtual Labs
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
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 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
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
Biofuels Curricullum
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 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
Presentation6 bioman course in a box wallman
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
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
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
                        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
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
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 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 )
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                      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.
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. 
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). 
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.
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.
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 t



Used at MCCC, GBCC, MWCC, and FLCC
Used 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
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
Presentation6 bioman course in a box wallman
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,
Training Workforce Statistics and Career Pathways




           www.biomanufacturing.org
             www.biomanonline.org
         www.biomanufacturingcareers.org
           BIOMAN Group on LinkedIn
Month        Sites    KBytes    Visits   Pages   Files   Hits


       y
February 2010   5137    32936942   6254     12063   24653   47189


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 
  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.
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.  
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
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
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, 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
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
Sustainability
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 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.
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.
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 Cash modules 
Online support site at www.biomanonline.org. 
Course in a Box


The NBC2 plan is to provide a ‘Course in a Box’ 
type of format to deliver the materials necessary 
      ff           d li    h        i l
to 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

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Presentation6 bioman course in a box wallman

  • 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.
  • 28. Downstream Processing Equipment Similarities Lab Scale  Industrial Scale  Chromatography System Ch t h S t Chromatography System Ch t h S t
  • 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
  • 39. 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).  /
  • 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.
  • 56. Course in a Box The NBC2 plan is to provide a ‘Course in a Box’  type of format to deliver the materials necessary  ff d li h i l to 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
  • 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
  • 58. 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