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Community College Program BIO 2010 in Chicago May 2, 2010

The NBC 2 and Advanced Technology Education for Biomanufacturing Technicians. Sonia Wallman, PhD NBC 2 Executive Director swallman@biomanufacturing.org. Community College Program BIO 2010 in Chicago May 2, 2010. Ten Technician Jobs Anchor Ten Biomanufacturing Departments.

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Community College Program BIO 2010 in Chicago May 2, 2010

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  1. 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

  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. Escherichia coli – GFP Escherichia coli Green Fluorescent Protein

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

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

  12. Curriculum Products Virtual Labs Online Complete Suite of Products Support Fall2010 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

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

  17. Chromatography Skid – ControllerEngineering 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: 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

  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 www.biomanonline.com with powerpoints, videos and seminal pdfs; also links to our print publications at www.lulu.com

  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 BIOMAN Conferences archived at www.biomanufacturing.org/facultydev.html

  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

  27. $Protein is the Cash$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

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

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