1. Community College Program
The NBC2 and Advanced Technology Education for Biomanufacturing Technicians
Sonia Wallman, PhD
NBC2 Executive Director
Community College Program
BIO 2010 in Chicago
May 2, 2010

2. 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

3. Biopharmaceutical Proteins are Parenteral

4. Pilot Plant – Overall Flow Plan

5. The Expression Vector: The Basis of Biotechnology Manufacturing

6. Green Fluorescent Protein
Escherichia coli – GFP
Escherichia coli
Green Fluorescent Protein

7. Upstream Downstream Process Overview
Large Scale Bioreactor
Wave
Bag
Seed Bioreactors
Fermentation
150L Bioreactor
750L Bioreactor
5,000L Bioreactor
26,000L Bioreactor
1 day
Media Prep
Working Cell
Bank
Sub-
Culture
Inoculum
Depth
Filtration
Collection
Centrifuge
Harvest/Recovery
24 days
31 days
Harvest
Collection
Tank
1,500L
Filter
Chromatography Skid
Anion Exchange Chromatography (QXL)
Column
Eluate
Hold
8,000L
6,000L
Protein A Chromatography
20,000L
Hydrophobic Interaction Chromatography (HIC)
Viral Inactivation
5,000L
Anion Exchange Chromatography (QFF - Fast Flow)
Post-viral
Vessel
3,000L
Viral Filtering
Ultra Filtration
Diafiltration
Bulk Fill
Purification
8 days

8. Upstream Processing Equipment
Large-Scale Bioreactor
25,000 liters
Lab-Scale Bioreactor
3 liters

9. Downstream Processing Equipment
Lab-Scale
TFF System
Large-Scale
TFF System

10. Downstream Processing Equipment
Lab Scale
Chromatography System
Large Scale
Chromatography System

11. 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
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 students
incumbent workers and program graduates

12. Complete Suite of Products
Curriculum Products
Virtual Labs
Online
Complete Suite of Products
Support
Fall 2010
Textbook
Laboratory
Manuals
Monographs
BIOMAN Job

13. Generic Laboratory Manual
(Facilities) Metrology SOPs Validation Protocols EH&S Program Quality Assurance: cGMP, SOPs, Batch Records, Equipment Logs Quality Control Microbiology SOPs E. coli recombinant for GFP Cell Culture SOPs CHO recombinant for tPA Cell Culture SOPs Pichia pastoris recombinant for HSA Cell Culture SOPs Purification of human tPA from CHO Cell Culture SOPs Purification of human serum albumin from Pichia pastoris Cell Culture SOPs Quality Control Biochemistry SOPs (Process Development)

14. $Protein is the CASH$ Teachers Workshop Manual

15. Biomanufacturing Textbook
Chapter Title
Author(s)
Introduction
John Dees , Textbook Editor
Operational Excellence in Biomanufacturing
X Martha Matthews, BiogenIdec
Education rep: Mary Jane Kurtz
Rick Lawless, UNC
Gray Ward, Wyeth
Facilities
X Bryan Shingle, Centocor
Education rep: Sonia Wallman
Ron Hudcosky, Merck
Joseph Lingle, Novartis
Metrology
X Gene Kernan, Human Genome Sciences
Education rep: Michael Fino, MiraCosta CC
Terry Corzine, Amgen
Validation
X Tom Burkett, CCBC
X Patrick Sheehy, Human Genome Sciences
Environmental, Health, and Safety (EH&S)
X John Piampiano, Kodak Education rep: Jim Hewlett Finger Lakes CC
Ed Wonilowicz, EH&S Consultant
Quality Assurance
X Cynthia Sarnoski, Wyeth
Education rep: Kevin Lampe, MCCC
Quality Control: Microbiology
X Peter Lowry, PhilaBio Education rep: Linda Rehfuss, MCCC Ed Balkovic, Genzyme
Production: Upstream Processing
X Olga Mollin, Lonza Biologics X Jane Flanagan, Lonza Biologics Education rep: Sonia Wallman
Production: Downstream Processing
X Paul O’Neil, Pall Euroflow
Education rep: Mary Jane Kurtz Minuteman HS
Heide Kuch, Wyeth
Quality Control: Biochemistry
X Mary Harne, Human Genome Sciences X Zhenhong Li, Human Genome Sciences Education rep: Linda Rehfuss, MCCC David Lewis, Genzyme
Process Development
X Eszter Birck-Wilson, STC Biologics Reviewer: Aaron Pilling, Cook Pharmica Alex Tschumakow, Shire

16. Curriculum Built on Harmonized Standards
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting Indianapolis, September 2007

17. Chromatography Skid – Controller Engineering and Advanced Technology
The Virtual Liquid Chromatography Laboratory showing the interactive controller which
enables students to operate the system and set process parameters.

18. 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.

19. The Virtual Chromatography Laboratory
URL:
To login enter your address and the password: CHICAGBIO
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 or

20. 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 with powerpoints, videos and seminal pdfs; also links to our print publications at

21. Curriculum Built on Harmonized Standards
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting Indianapolis, September 2007

22. 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

23. Overview NBC2 BIOMAN National Faculty Development Conferences
YEAR
# Participants HS Teachers,
CC 4yr Faculty, Technicians, Others
# Community College Participants
2006 39 24
2007 43 32
2008 49 40
2009 41 31
BIOMAN Conferences archived at

24. $Protein is Cash$ Local Teachers Workshops

25. 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).

26. Workshop Data Workshop Location Teacher Number NBC2 Instructors
Local Partner
Presentations
Credit
Providence, RI
March 6, 13, 20, 27, and
April 10 19
Mary Jane Kurtz
Sonia Wallman
Bruce Van Dyke
Dana Hopkins
Christina Befumo
Tim Pelletier, RI EPSCoR
Greg Paquette, URI
Scott Warila,CCRI
David Vito, Bruce Wallace Biotechnology Program
Jim Wilkie, Wilkem Scientific
Andrew Andrew Staroscik , RI EPSCoR – Importance of Leveraging/Partnering
Denise Spero, EpiVax Tour: 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, NY
March 22-25 24
Jason McMillan
Sherri Andrews, Bio-Rad
Peter Schaefer, HVCC
Elizabeth Herkenham, Workforce Consortium
Ted Hennessy, Questar
Tour: Regeneron
N/A
Lexington, MA
April 20-23 14
Joan Jasset
Patrick Rafter
35 pdp (professional development points)
MA requires 109 pdp/3 yrs

27. $Protein is the Cash$ Teachers Workshops
Rhode Island Consortium, RI March 6, 13, 20, 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

28. Website Statistics for www.biomanufacturing.org
February 2009
February 2010