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The NBC 2 and Advanced Technology Education for Biomanufacturing Technicians. Sonia Wallman, PhD NBC 2 Executive Director [email protected] Community College Program BIO 2010 in Chicago May 2, 2010. Ten Technician Jobs Anchor Ten Biomanufacturing Departments.

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The NBC2 and Advanced Technology Education for Biomanufacturing Technicians

Sonia Wallman, PhD

NBC2 Executive Director

[email protected]

Community College Program

BIO 2010 in Chicago

May 2, 2010


Ten technician jobs anchor ten biomanufacturing departments
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




The expression vector the basis of biotechnology manufacturing
The Expression Vector:The Basis of Biotechnology Manufacturing


Escherichia coli gfp
Escherichia coli – GFP

Escherichia coli

Green Fluorescent Protein


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


Upstream processing equipment
Upstream Processing Equipment

Lab-Scale Bioreactor

3 liters

Large-Scale Bioreactor

25,000 liters


Downstream processing equipment
Downstream Processing Equipment

Lab-Scale

TFF System

Large-Scale

TFF System


Downstream processing equipment1
Downstream Processing Equipment

Lab Scale

Chromatography System

Large Scale

Chromatography System


An advanced technology stem career path
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
Curriculum Products

Virtual Labs

Online

Complete Suite of Products

Support

Fall2010

Textbook

Laboratory

Manuals

Monographs

BIOMAN Job


Generic laboratory manual
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
$Protein is the CASH$ Teachers Workshop Manual



Curriculum Built on Harmonized Standards

Harmonization of Biopharmaceutical Manufacturing Skill Standards Meeting Indianapolis, September 2007


Chromatography skid controller engineering and advanced technology
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.


Chromatography skid chromatography science and technology
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
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 [email protected]


Job monographs validation
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
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 nbc 2 bioman national faculty development conferences
Overview NBC2 BIOMAN National Faculty Development Conferences

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


Protein is cash local teachers workshops
$Protein is Cash$ Local Teachers Workshops


Growing the local biotech biomanufacturing network across the nation
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).



Protein is the cash teachers workshops
$Protein is the Cash$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


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