The NBC2 and Advanced Technology
Education for Biomanufacturing Technicians
Sonia Wallman, PhD
NBC2 Executive Director
swallman@biomanufacturing.org
Community College Program
BIO 2010 in Chicago
May 2, 2010
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
Upstream Downstream Process Overview
Large Scale Bioreactor
1 day
Media Prep
Seed Bioreactors
Working Cell
Bank
150L
Bioreactor
SubCulture
SubCulture
SubCulture
SubCulture
SubCulture
Centrifuge
Depth
Filtration
Collection
Harvest/Recovery
Fermentation
24 days
31 days
Column
Chromatography
Skid
Harvest
Collection
Tank
750L
Bioreactor
26,000L
Bioreactor
Wave
Bag
Inoculum
Filter
5,000L
Bioreactor
Eluate
Hold
Tank
Viral
Inactivation
Column
Chromatography
Skid
8,000L
Eluate
Eluate Hold
Hold Tank
Tank
20,000L
20,000L
1,500L
Anion Exchange
Chromatography (QXL)
Hydrophobic Interaction
Chromatography (HIC)
Purification
Filter
Column
Chromatography
Skid
Filter
Eluate
Hold
Tank
Post-viral
Hold
Vessel
3,000L
6,000L
Protein A
Chromatography
Viral Filtering
8 days
Column
Chromatography
Skid
Eluate
Hold
Tank
5,000L
Anion Exchange
Chromatography (QFF Fast Flow)
Ultra Filtration
Diafiltration
Bulk
Fill
Upstream Processing Equipment
Lab-Scale Bioreactor
3 liters
Large-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 students
incumbent workers and program graduates
Curriculum Products
Virtual Labs
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)
$Protein
is the CASH$ Teachers Workshop Manual
Biomanufacturing Textbook
Chapter Title
Introduction
Operational Excellence in Biomanufacturing
Facilities
Metrology
Validation
Environmental, Health, and Safety (EH&S)
Quality Assurance
Quality Control: Microbiology
Production: Upstream Processing
Production: Downstream Processing
Quality Control: Biochemistry
Process Development
Author(s)
John Dees , Textbook Editor
X Martha Matthews, BiogenIdec
Education rep: Mary Jane Kurtz
Rick Lawless, UNC
Gray Ward, Wyeth
X Bryan Shingle, Centocor
Education rep: Sonia Wallman
Ron Hudcosky, Merck
Joseph Lingle, Novartis
X Gene Kernan, Human Genome Sciences
Education rep: Michael Fino, MiraCosta CC
Terry Corzine, Amgen
X Tom Burkett, CCBC
X Patrick Sheehy, Human Genome Sciences
Education rep: Michael Fino, MiraCosta CC
X John Piampiano, Kodak
Education rep: Jim Hewlett Finger Lakes CC
Ed Wonilowicz, EH&S Consultant
X Cynthia Sarnoski, Wyeth
Education rep: Kevin Lampe, MCCC
Ron Hudcosky, Merck
X Peter Lowry, PhilaBio
Education rep: Linda Rehfuss, MCCC
Ed Balkovic, Genzyme
X Olga Mollin, Lonza Biologics
X Jane Flanagan, Lonza Biologics
Education rep: Sonia Wallman
X Paul O’Neil, Pall Euroflow
Education rep: Mary Jane Kurtz Minuteman HS
Heide Kuch, Wyeth kuch@wyeth.com
X Mary Harne, Human Genome Sciences
X Zhenhong Li, Human Genome Sciences
Education rep: Linda Rehfuss, MCCC
David Lewis, Genzyme
X Eszter Birck-Wilson, STC Biologics
Reviewer: Aaron Pilling, Cook Pharmica
Alex Tschumakow, Shire
Curriculum Built on Harmonized Standards
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting
Indianapolis, September 2007
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.
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/
To login enter your email 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
781-842-3300
or
YCherner@ATeLearning.com
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
Curriculum Built on Harmonized Standards
Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting
Indianapolis, September 2007
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
YEAR
# Participants # Community
HS Teachers,
College
CC 4yr Faculty,
Participants
Technicians, Others
2006
39
24
2007
43
32
2008
49
40
2009
41
31
BIOMAN Conferences archived at www.biomanufacturing.org/facultydev.html
$Protein
is Cash$ 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 Data
Workshop
Location
Teacher NBC2 Instructors
Number
Providence, RI
March 6, 13,
20, 27, and
April 10
19
Troy, NY
March 22-25
Lexington, MA
April 20-23
Local Partner
Presentations
Credit
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
24
Sonia Wallman
Dana Hopkins
Jason McMillan
Christina Befumo
Sherri Andrews, Bio-Rad
Peter Schaefer, HVCC
Elizabeth Herkenham,
Workforce Consortium
Ted Hennessy, Questar
Tour: Regeneron
N/A
14
Mary Jane Kurtz
Sonia Wallman
Christina Befumo
Joan Jasset
Sherri 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







Hudson Valley CC, Troy, NY
Minuteman Regional HS, Lexington, MA
Hillsborough CC, Tampa, FL
Mesa CC, Mesa, AZ
Great Bay CC, Portsmouth, NH
Northern Virginia CC – Loudoun, VA
Middlesex CC, Edison, NJ
March 6, 13, 20, 27
April 10, 2010
March 22-25, 2010
April 20-23, 2010
June 14-18, 2010
June 22-26, 2010
June 28-July 2, 2010
August 16-20, 2010
August 23-27, 2010
Website Statistics for www.biomanufacturing.org
February 2009
February 2010