Community College ProgramBIO 2010 in Chicago

May 2, 2010

The NBC2 and Advanced Technology Education for Biomanufacturing TechniciansSonia Wallman, PhDNBC2 Executive Directorswallman@biomanufacturing.org

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 kuch@wyeth.com

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 YCherner@ATeLearning.com

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