Community College Program 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 www.bio.davidson.edu/.../plasmid_inducible.html

Green Fluorescent Protein Escherichia coli – GFP Escherichia coli Green Fluorescent Protein

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

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

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

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 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 kuch@wyeth.com 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

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 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 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 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

$Protein is the Cash$ 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

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