community college program bio 2010 in chicago may 2, 2010 the nbc 2 and advanced technology...
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Community College ProgramBIO 2010 in Chicago
May 2, 2010
The NBC2 and Advanced Technology Education for Biomanufacturing TechniciansSonia Wallman, PhDNBC2 Executive [email protected]
Ten Technician Jobs Anchor Ten Biomanufacturing Departments
• Facilities/Metrology• Validation• Environmental Health
and Safety (EH&S)• QA• Upstream Processing• Downstream Processing• QC Microbiology• QC Biochemistry• Process Development
Biopharmaceutical Proteins are Parenteral
Pilot Plant – Overall Flow Plan
The Expression Vector:The Basis of Biotechnology Manufacturing
Escherichia coli – GFP Escherichia coli
Green Fluorescent Protein
Media PrepMedia Prep
Working Cell Bank
Working Cell Bank
Sub- Culture
Sub- Culture
Inoculum
Sub- Culture
Sub- Culture Sub-
Culture
Sub- Culture Sub-
Culture
Sub- Culture Sub-
Culture
Sub- Culture
Large Scale Bioreactor
Wave Bag
Wave Bag
Seed Bioreactors
Fermentation
150L Bioreactor
750L Bioreactor
5,000L Bioreactor
26,000L Bioreactor
Depth Filtration
Depth Filtration
CollectionCollection
CentrifugeCentrifuge
Harvest/Recovery
HarvestCollection
Tank
1,500L
HarvestCollection
Tank
1,500L
FilterChromatography
Skid
Anion Exchange Chromatography (QXL)
Column EluateHold Tank
8,000L
EluateHold Tank
8,000L
EluateHold Tank
6,000L
EluateHold Tank
6,000L
FilterChromatography
Skid
Protein A Chromatography
Column
Chromatography Skid
ColumnEluateHold Tank
20,000L
EluateHold Tank
20,000L
Hydrophobic Interaction Chromatography (HIC)
EluateHold Tank
20,000L
EluateHold Tank
20,000L
Viral Inactivation
EluateHold Tank
5,000L
EluateHold Tank
5,000L
FilterChromatography
Skid
Anion Exchange Chromatography (QFF -
Fast Flow)
Column
Post-viralHold
Vessel3,000L
Post-viralHold
Vessel3,000L
Viral Filtering Ultra FiltrationDiafiltration
Bulk Fill
Purification
24 days 31 days
8 days
1 dayUpstream Downstream Process Overview
Upstream Processing EquipmentLab-Scale Bioreactor
3 litersLarge-Scale Bioreactor
25,000 liters
Downstream Processing Equipment
Lab-Scale TFF System
Large-Scale TFF System
Downstream Processing Equipment
Lab Scale Chromatography System
Large Scale Chromatography System
An Advanced Technology STEM Career Path
The advent of this new advanced technology STEM career path stimulated the development of curriculum and a support structure:
Hands-on laboratories in the form of Standard Operating Procedures (SOPs) and a textbook written by industry
Website for online support at www.biomanonline.com Conferences and workshops for faculty development re:
biomanufacturing curriculum and networking (BIOMAN Conferences and $Protein is the Cash$ Teachers Workshops)
Opportunities for education and training by all levels: high school, community college, and university studentsincumbent workers and program graduates
Curriculum Products
BIOMAN Job
Laboratory
Textbook
Online Support
Virtual Labs
Monographs ManualsCo
mpl
ete
Suite
of P
rodu
cts
Fall 2010
Generic Laboratory Manual
(Facilities)Metrology SOPsValidation ProtocolsEH&S ProgramQuality Assurance: cGMP, SOPs, Batch
Records, Equipment LogsQuality Control Microbiology SOPsE. coli recombinant for GFP Cell Culture SOPs CHO recombinant for tPA Cell Culture SOPsPichia pastoris recombinant for HSA Cell
Culture SOPsPurification of human tPA from CHO Cell
Culture SOPsPurification of human serum albumin from
Pichia pastoris Cell Culture SOPsQuality Control Biochemistry SOPs(Process Development)
$Protein is the CASH$ Teachers Workshop Manual
Biomanufacturing TextbookChapter Title Author(s)
Introduction John Dees , Textbook Editor Operational Excellence in Biomanufacturing X Martha Matthews, BiogenIdec
Education rep: Mary Jane KurtzRick Lawless, UNCGray Ward, Wyeth
Facilities X Bryan Shingle, CentocorEducation rep: Sonia WallmanRon Hudcosky, MerckJoseph Lingle, Novartis
Metrology X Gene Kernan, Human Genome SciencesEducation rep: Michael Fino, MiraCosta CCTerry Corzine, Amgen
Validation X Tom Burkett, CCBC X Patrick Sheehy, Human Genome SciencesEducation rep: Michael Fino, MiraCosta CC
Environmental, Health, and Safety (EH&S) X John Piampiano, KodakEducation rep: Jim Hewlett Finger Lakes CC Ed Wonilowicz, EH&S Consultant
Quality Assurance X Cynthia Sarnoski, Wyeth Education rep: Kevin Lampe, MCCCRon Hudcosky, Merck
Quality Control: Microbiology X Peter Lowry, PhilaBioEducation rep: Linda Rehfuss, MCCC Ed Balkovic, Genzyme
Production: Upstream Processing X Olga Mollin, Lonza BiologicsX Jane Flanagan, Lonza BiologicsEducation rep: Sonia Wallman
Production: Downstream Processing X Paul O’Neil, Pall EuroflowEducation rep: Mary Jane Kurtz Minuteman HSHeide Kuch, Wyeth [email protected]
Quality Control: Biochemistry X Mary Harne, Human Genome SciencesX Zhenhong Li, Human Genome SciencesEducation rep: Linda Rehfuss, MCCC David Lewis, Genzyme
Process Development X Eszter Birck-Wilson, STC BiologicsReviewer: Aaron Pilling, Cook PharmicaAlex Tschumakow, Shire
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting Indianapolis, September 2007
Curriculum Built on Harmonized Standards
Chromatography Skid – ControllerEngineering and Advanced Technology
The Virtual Liquid Chromatography Laboratory showing the interactive controller whichenables students to operate the system and set process parameters.
Chromatography Skid –Chromatography Science and Technology
The Virtual Chromatography Laboratory showing the operation of the chromatography system during the ‘elution’ phase, the chromatogram showing the beginning of the peak of the protein 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.
The Virtual Chromatography Laboratory
URL: http://ATeLearning.com/BioChrom/
If you will have any problems with or questions regarding the Virtual Chromatography Laboratory, feel free to contact Dr. Yakov Cherner of ATeL, LLC at 781-842-3300 or [email protected]
To login enter your email address and the password: CHICAGBIO
Job Monographs: Validation• Validation Chapter from Biomanufacturing Textbook
Chapter by Tom Burkett, CCBC; Pat Sheehey, HGSI; and Mike Fino, MiraCosta
• Hands-On Labs:– Operational Qualification Protocol for Autoclave– Bioreactor Vessel Sterilization Validation Protocol– Forward Flow Filter Integrity Test for TFF System
Protocol– UV-VIS Spectrophotometer Method Validation
Protocol– Bioreactor Cleaning Validation Protocol
• GBC Validation Job Competencies• Support website at www.biomanonline.com with
powerpoints, videos and seminal pdfs; also links to our print publications at www.lulu.com
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting Indianapolis, September 2007
Curriculum Built on Harmonized Standards
Crossover Industry Modules 2009-2012
• Ethanol from Corn by Jim Hewlett at FLCC, Canandaigua, NY and the Upstate NY Hub
• Cellulosic derived Ethanol by Jim Hewlett at FLCC and the Upstate NY Hub
• Biofuels from Microalgae by Dr. Elmar Schmid, adjunct professor at MiraCosta College, Oceanside, CA and the Western Alliance
• Regenerative Medicine by the BioPharma Hub in Blue Bell, PA
Overview NBC2 BIOMAN National Faculty Development
Conferences
BIOMAN Conferences archived at www.biomanufacturing.org/facultydev.html
BIOMANYEAR
# ParticipantsHS Teachers,
CC 4yr Faculty, Technicians, Others
# Community College
Participants
2006 39 24
2007 43 32
2008 49 40
2009 41 31
$Protein is Cash$ Local Teachers Workshops
Growing the Local Biotech/Biomanufacturing Network across the Nation
• Build the local biotech/biomanufacturing high school, community college, university and industry network:– Hold workshop at local community college teaching
biomanufacturing– Invite local biology, chemistry and biotechnology high school
teachers– Grant graduate credit through local university for workshop– Tour local biomanufacturer– Present local industry folks, including supplier(s) of
biotechnology and biomanufacturing equipment and materials• Teach teachers the theory/hands-on of biopharmaceutical
biomanufacturing (and crossover industries).• Educate teachers re: local opportunities for STEM
biomanufacturing education and training and careers (biomanufacturing career paths).
Workshop DataWorkshop Location
TeacherNumber
NBC2 Instructors Local PartnerPresentations
Credit
Providence, RIMarch 6, 13, 20, 27, andApril 10
19 Mary Jane KurtzSonia Wallman Bruce Van DykeDana Hopkins Christina Befumo
Tim Pelletier, RI EPSCoRGreg Paquette, URIScott Warila,CCRIDavid Vito, Bruce Wallace Biotechnology ProgramJim Wilkie, Wilkem ScientificAndrew Andrew Staroscik , RI EPSCoR – Importance of Leveraging/PartneringDenise Spero, EpiVaxTour: Amgen-RI
3 URI graduate credits for MTC 594: Special Problems in Biotechnology: Best Practices in Biotechnology and Biomanufacturing Curriculum Development$150/credit; discount from $450/credit
Troy, NYMarch 22-25
24 Sonia WallmanDana HopkinsJason McMillanChristina BefumoSherri Andrews, Bio-Rad
Peter Schaefer, HVCCElizabeth Herkenham, Workforce ConsortiumTed Hennessy, QuestarTour: Regeneron
N/A
Lexington, MAApril 20-23
14 Mary Jane KurtzSonia WallmanChristina BefumoJoan JassetSherri Andrews, Bio-Rad
Patrick Rafter 35 pdp (professional development points)MA requires 109 pdp/3 yrs
$Protein is the Cash$
Teachers Workshops
Rhode Island Consortium, RI March 6, 13, 20, 27 April 10, 2010
Hudson Valley CC, Troy, NY March 22-25, 2010 Minuteman Regional HS, Lexington, MA April 20-23, 2010 Hillsborough CC, Tampa, FL June 14-18, 2010 Mesa CC, Mesa, AZ June 22-26, 2010 Great Bay CC, Portsmouth, NH June 28-July 2, 2010 Northern Virginia CC – Loudoun, VA August 16-20, 2010 Middlesex CC, Edison, NJ August 23-27, 2010
February 2009 February 2010Website Statistics for www.biomanufacturing.org