Protein is Cash - Northeast Biomanufacturing Collaborative

beefzoologistBiotechnology

Feb 21, 2013 (4 years and 1 month ago)

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Advisory Board Meeting


September 17th, 2010

NBC
2

Phase II
-
Accomplishments



‘Protein is Cash’ teachers workshops

Sonia Wallman

A Workshop to Instruct Teachers and Students


in

Biomanufacturing and the Bioeconomy


The Bioscience Industry is Hot


National Bioscience Report Shows Growth

View the complete 2010 Battelle Report

The Battelle Report 2010



“Although post
-
secondary bioscience
graduates grew 12.6% from 2006 to 2008,
wide disparities exist among states in K
-
12
student performance in the biosciences and
broader sciences. The United States continues
to fall behind in math and science and we may
have trouble meeting the needs of our
bioscience companies for skilled, technical
workers.”


Bio
-
Rad Partnership


In order to promote attractive careers in the STEM
(science, technology, engineering and mathematics)
field of biomanufacturing, the Northeast
Biomanufacturing Center and Collaborative (NBC2) is
partnered with Bio
-
Rad to provide teachers with
engaging hands
-
on biomanufacturing education and
training modules in metrology, production (upstream
and downstream processing), quality control
biochemistry and clinical trials. These modules can
be brought directly into the high school classroom.


Growing the Local Biotech/Biomanufacturing

Network across the Nation


Build the local biotech/biomanufacturing high school, community college,
university and industry network:


Hold
Protein is Cash
workshop at local community college teaching
biotechnology/biomanufacturing


Invite local biology, chemistry, physics and biotechnology high school teachers


Grant graduate credit through local university for workshop


Tour local biomanufacturer


Present local educators from universities and community colleges


Present local industry , including local supplier(s) of biotechnology and
biomanufacturing equipment and supplies


Teach teachers the theory/hands
-
on of biopharmaceutical biomanufacturing (and
relate to crossover industries).


Educate teachers re: local opportunities for STEM biomanufacturing education
and training and careers (biomanufacturing career paths).



$
Protein is Cash
$

Local Teachers
Workshops

$
Protein is the CASH
$

Teachers
Workshop Manual

Protein is Cash
Support Website

Protein is Cash 2010 Workshop
Overview

Summary of 2010
Protein is Cash
Workshops


Six
Protein is Cash
teachers’ workshops hosted by four community colleges
in four states (NY, FL, AZ, NH), one high school (MA) and one university (RI)


103 teachers educated and trained for career pathways in
biomanufacturing. In one year they will touch 100 students so there is a
possibility that 10,300 will be influenced by the
Protein is Cash
workshop.


New partners: 114 educators, 3 industry and 4 organizations.


Media coverage by a grant (EPSCoR
-
RI), community TV (NYY Community
TV), and blogs (FLATE focus).


Help for the following teachers to incorporate biomanufacturing into their
courses and programs: James Leach, RI; Matthew Christian, upstate NY;
Greg Panzanaro, upstate, NY; Liz Taylor, NH; Erica Ferland, NH


Increased local awareness of the opportunities available in this STEM
advanced technological career pathway.


Future (2011)

Schedule of the 2011
Protein is Cash
Workshops:


May 23
-
27 at UPR, Barcelonetta, PR (tour Abbott)


June 13
-
17 at Houston CC, Houston, TX


June 27
-
July 1 at Middlesex CC, Edison, NJ (tour Merck)


July 18
-
22 at Blue Grass CTC, Lexington, KY


Northampton CC, Bethlehem, PA


Ivy Tech CC, Indianapolis, IN


LA Trade Tech, Los Angeles, CA


Leeward CC, Oahu, HI


Future (2011
-
2015)


Goal is to hold one
Protein is Cash

workshop in every
state and empower the host institution in each state
to take over teaching the workshop to others (we
may have done workshops in 14/50 states by the end
of 2011 and 22/50 states by the end of 2012 or
about 50% of the states).


In our next grant we will propose to continue these
workshops so that by 2015 we would have offered
Protein is Cash
in all 50 states.


Partnership with ScienceBridge


A number of teachers who experience the
Protein is Cash
workshop request more training. For more training we will
partner with the ScienceBridge in San Diego, CA. We have
joined them in a grant submission for the DOE FIPSE program.
Mary Jane Kurtz, Edward Boquillon, Principal of Minuteman
Regional High School, and I wrote letters of support for the
grant. Mary Jane and I will train with the ScienceBridge and
then train MRHS teachers. MRHS will biomanufacture science
kits for use by district high schools. We will also identify more
high schools in Massachusetts, and other states that will
produce kits in partnership with ScienceBridge.


Future (2011
-
2015)


In an analogy to a pyramid structure business model, the place where the
first workshop was offered facilitates ‘Protein is Cash’ workshops at
community college biotech/biomanufacturing education and training
facilities throughout the state.


Many high schools in each state incorporate PiC modules into their STEM
classes.


Throughout the PiC workshops, teachers who want more
biomanufacturing education and training are identified.


These teachers are invited to a ScienceBridge workshop in which they are
taught how to teach biomanufacturing through biomanufacture of kits
containing supplies and materials for high school biology, chemistry and
biotechnology classes for their own school and for district schools.


We are also partnered with the San Francisco Bay Area Consortium (Katy
Korsmeyer)and the Mesa Biotech Academy (Xan Simonson) as Science
Bridge expands from San Diego “to distant regions”.


Results 2015


Almost all high school students have experienced a
hands
-
on biomanufacturing lesson and are aware of
the bioeconomy and the attractive jobs available in
biotechnology/biomanufacturing.


Because kits are provided by local high schools for very
low cost, the effort is self
-
sustaining.


More high school graduates go on to community
colleges and universities to pursue STEM advanced
technology careers in biotechnology/biomanufacturing

NBC2 Phase II Accomplishments

Biomanufacturing Textbook

Biomanufacturing Textbook

Maggie Bryans


Textbook Editor


John Dees


12 Chapters


Chapters 50 pages on average


10
-
12 questions, 3
-
4 activities


Target audience


Biomanufacturing students
at 2 and 4 year colleges, Biomanufacturing
industry employees


Chapters written by an industry expert in
collaboration with a college educator

Chapters


INTRODUCTION


John Dees, Sonia Wallman


OPERATIONAL EXCELLENCE


Martha Mathews
Biogenidec Inc
.
Education Rep
-

Mary Jane Kurtz, NBC2 Consultant


FACILITIES
-

Brian

Shingle,
Centocor


Education Rep


Sonia Wallman


METROLOGY


Gene Kernan,
Human Genome Sciences Inc.


Education Rep


Mike Fino, MiraCosta College


VALIDATION


Patrick Sheehy
, Human Genome Sciences Inc.


Education Rep
-

Tom Burkett, CCBC, Mike Fino MC


ENVIRONMENTAL HEALTH and SAFETY


John Piampiano,
Kodak


Education Rep


Jim Hewlett, Finger Lakes CC

Chapters


QUALITY ASSURANCE


Cynthia Sarnoski, formerly
Wyeth


Frank Hallinan,
Pfizer


Education Rep


Kevin Lampe, MCCC


QUALITY CONTROL BIOCHEMISTRY


Mary Harne,
HGSI


Zhenghong Li,
HGSI


Education Rep


Linda Rehfuss, Bucks County CC


Kevin Lampe, MCCC


QC MICROBIOLOGY/ MICROBIOLOGICAL CONTROL


John
Hasyn, MCCC and Frank Hallinan,
Pfizer


Education Rep


Linda Rehfuss, BCCC

Chapters


UPSTREAM PROCESSING


Olga Mollin and Jane Flanagan,


Lonza Biologics


Education Rep


Sonia Wallman


DOWNSTREAM PROCESSING


Paul O’Neil,
Pall Euroflow


Education Rep


Mary Jane Kurtz


PROCESS DEVELOPMENT


Eszter Birck
-
Wilson,
Consultant


Education Rep


Sonia Wallman


Textbook Layout

Cluster: Engineering


(Cluster Overview, Operational Excellence,
Facilities, Metrology, Validation, EHS)

Cluster: Quality Systems


(Cluster Overview, Quality Assurance, QC
Biochem, Micro, Microbiological Control)

Cluster: Production


(Cluster Overview, Upstream Processing,
Downstream Processing, Process Development )




Progress


2 day authors meeting June 2010 at MCCC


Weekly conference call for each cluster


6 chapters at final draft stage


2 chapters at second draft stage


3 chapter at first draft stage


Illustrator onboard to work with chapter
authors


Introduction and Section Overviews to be
discussed at next authors meeting

Time
-

line


October 15
th



final draft of all chapters due


Nov. 1
st

-

textbook review copy distributed to all
authors


Nov. 18/19


textbook authors meeting, MCCC


final edits, introduction discussed, cluster overviews
outlined (5
-
10 pages)


Dec. 1
st



introduction, cluster overviews due


Dec. 15
th



final draft of textbook ready for review


Jan. 7
th

-

final textbook review edits complete


Jan.14
th



textbook ready for publication






Next Steps


Early Spring 2011


begin publication/distribution


Publication on Lulu


Spring 2011
-

conduct pilot/feedback program


-

provide instructor review copies



Fall 2011


textbook available, monitor textbook
adoption


Spring
-
Fall 2011
-

Create web
-
based courses

Laboratory Manuals



Generic


Custom


CHO


tPA


Pichia pastoris
-

HSA


Protein is Cash


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)


NBC
2

Biomanufacturing

Laboratory Manual Adopters



Mount Wachusett Community College (BMS is
biomanufacturer partner)


Minuteman Regional High School Adult Evening
Program (Shire is biomanufacturer partner)


Hudson Valley Community College (Regeneron is
biomanufacturer partner)


Great Bay Community College (Lonza and Stryker
are biomanufacturer partners)


Montgomery County Community College

NBC2 Accomplishments

Certification

Certification

Linda Rehfuss


Compared to Accreditation



Aspects of Certification



Costs



Timeline

Accreditation/ Certification


Accreditation


A validation process by which an institution of
higher education and/or specific programs within
that institution are evaluated against established
standards


Certification


The formal recognition of an individual’s skills,
expertise, and comprehension of a specified body
of knowledge

Certified Biomanufacturing
Technician
-

Aspects

A certified Biomanufacturing Technician would be
competent in the fundamentals of Biomanufacturing
including:



Manufacturing upstream



Manufacturing downstream



Quality control microbiology, biochemistry



Maintenance and Instrumentation



Process Development



Validation


Steps Towards Establishing a
Certification Program


Determine skills and knowledge standards for
Biomanufacturing Technicians


industry expert input


Develop an Assessment Blueprint


This will include core competencies and tasks, areas
covered, sample questions, sample job, administration time,


number of questions, etc.


Develop Items, pretest items


Analyze items and assemble test


Test delivery, scoring and analysis



Non
-
Profit Organizations That
Develop Certification Programs


ACT Inc, formerly The American College
Testing Program
-

preliminary phone calls and
a proposal has been developed with ACT




NOCTI
-

National Occupational Competency
Testing Institute


Cost of Certification


$75,000 to $90,000, which includes:


Phase 1


Test content outline
-

national web
-
based task
surveys


Knowledge and skill linking survey


Meetings with industry experts


Data analysis


Content specs for the exam


NOTE: does not include travel and meeting costs


Cost cont’d


Phase 2


additional $75,000 to $90,000,
which includes:


Item writing for actual test


Editorial review


Test assembly


Pilot study


Psychometric review


Passing score study


Delivery and maintenance



Time line


Phase 1


6 to 12 months


Pay for by using some funds from current phase of
NBC2 and some supplemental funding


Phase 2


6 to 18 additional months


Ask for funds in NBC2 phase III application


Other Accomplishments 2010


BIOMAN Conference


Bio
-
Link


CCP
-
BIO


Hi
-
Tec


Biofuels Curriculum


BEAM


Virtual Learning


upstream processing


BIOMAN 2010 Conference




July 12
-
15, 2010

Ivy Tech Comm. Coll.,

Bloomington, Indiana



44 Participants



4 High School teachers sponsored



15 Hands
-
on Biomanufacturing workshops



Industry tours


Cook
Pharmica
, Baxter
Biopharma



Vendor show



Panel discussions



3 Keynote speakers:

-

Medical Devices
, Dr. D. Chadwick, Cook Medical

-

Lyophilization

in Biotechnology
, Dr. M. Akers, Baxter
BioPharma

Solutions

-

Cell line Development in Biomanufacturing
, Dr. A.
Pilling, Cook
Pharmica





BIOMAN 2011


MiraCosta College, Oceanside, CA



July 11
-
14, 2011



Focus on Biofeuls and Bioprocessing


Speakers from Novartis, Sapphire Energy,
Genetech


Tour of Genetech and a


biofuels
-
related industry

CCP BIO 7
th

Annual Program

Chicago, IL


May 2
nd

2010


Regional Bioscience/Biomanufacturing
Collaboratives
-

Sonia Wallman, Chair


Emerging Biotechnology Programs
-

Russ Read,
Chair


Faces of Success


Our Graduates on their
Careers
-
Elaine Johnson, Chair


Accreditation and/or Certification for
Biotechnology
-
A Goal or a Digression?
-

Lisa
Seidman, Chair


Statistics on CCP BIO


59 Attendees @ $150 (bonus is free three day pass to the BIO
Exhibit Hall and joining the Biotechnology Institute for
reception and dinner)


Expenses

for food and a/v


$5,768.15


Income

from registration and $1,000 sponsorship from the
National Center for the Biotechnology Workforce
$9,404.00


Profit





$3,635.85

Bio
-
Link Summer Fellows, Berkeley, CA

June 1
-
4, 2010

Panel on Biotechnology/Biomanufacturing Programs:


Bill Woodruff at Alamance CC, Graham, NC


Jim DeKloe at Solano CC, Fairfield, CA


Lara Dowland at Mt Wachusett CC in Devens, MA


Danielle Thompson at Mt Wachusett CC in Devens,
MA


Tour of Bio
-
Rad’s kit production facility in Hercules,
CA


HI
-
TEC

Orlando, FL


July 26
-
29, 2010



NBC2 is an Associate Producer (which entitles NBC2
to an exhibit booth for the Technology Show Case
and four free registrations: Sonia Wallman, Xan
Simonson from the AZ
Protein is Cash
group and
Elizabeth Herkenham and Hillary Reilly from NY
Protein is Cash
group).


NBC2 Session: Yakov Cherner of ATeL and Sonia
Wallman on
Blended Learning for Biomanufacturing
Students
.


Website Statistics for
www.biomanufacturing.org


Biofuels


Development of Biofuels Curriculum

Elmar Schmid Ph.D., Associate Faculty, MiraCosta
College, Oceanside, CA


5
-
week lecture and lab course

Biofuels Curriculum Outline

Lectures




1.
Introduction: fuels and fossil fuels situation

2.
Energy and Gases

3.
Biomass, Enzymes and
Cellulases

4.
Algae

5.
Biofuels

Labs




1.
Culture media & Microbial cultivation techniques

2.
Cellobiase

enzyme activity assays

3.
Bacterial
biohydrogen

production

4.
Algae cultivation for biomass and oil production


BEAM


BEAM


Bioeconomy Alliance of the Mid
-
West

Sengyong Lee Ph.D

Ivy Tech Community College, Bloomington,IN

Virtual Learning

Yakov Cherner, AteL



Virtual Chromatography module


complete


Upstream Processing


currently being
developed


NBC2 Phase III Application

NBC2 Renewal


Renewal as a regional center


Goals of Phase III


Partners


Budget
-

PI, Hubs, Alliances


Time line


Renewal as a Regional Center


Other considerations..national or resource
center…but regional center renewal seems
ideal


PI from MCCC (Maggie) or Bucks (me)
-

college
that is not the PI will become a hub or alliance
partner to the lead institution


Align with Bio
-
Link or other centers (doing this
now but expand upon it)



Major goals of Phase III


Complete certification phase II and launch


National dissemination of
Protein is Cash


Ramp up crossover industry curriculum
development (biofuels, regenerative
medicine)


On
-
line module development
-

for faculty to
customize



Partners


Hubs and Alliances



MCCC and Bucks would co
-
lead large pharma hub


Finger Lakes CC


CC of Baltimore County


Miracosta CC


Alamance CC


Ivy Tech CC


Any additional sites?

Budget
-

PI, Hubs and Alliances


Grant PI would be fiscal agent


All hubs and alliances would receive a
subcontract for specific activities
-

so partner
would go unfunded or only funded for an
activity (such as for hosting BIOMAN only)


Distribution of funds could be on specific
sector…such as work on crossover, etc.



Time line


Preliminary proposal due April 2011


Feedback from preliminary proposal June
-
July
of 2011


Full proposal due October 2011


If funded, start date September 2012, to allow
uninterrupted funding with phase II


Grant funded through August 2015