Annual Report - Northeast Regional Biomanufacturing Collaborative

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Dec 3, 2012 (4 years and 10 months ago)

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MCCC (Rehfuss) NBC
2

annual report

Cumulative Sept 05
-
Mar 07

1






Northeast Biomanufacturing Center and Collaborative (
NBC
2
)

Large
Pharma (PA/NJ

and southern NY
) Hub

Annual Report

September 2005
-
March

2007


Introduction

Created in 2005 by a grant from the National Science Foundation (NSF


grant
#0501953), the goal

of the Northeast Biomanufacturing Center and Collaborative (NBC
2
)
is to form a self
-
sustaining alliance of community colleges working in collaboration with
in
dustry, education, state agencies and
government to assist in the training of a 21
st

century biot
echnology and biomanufacturing workforce for the biotechnology and
pharmaceutical industry.

Montgomery County Community College Biotechnology Program

Montgomery County
Community College (MCCC) is a 2
-
campus community college

(Blue Bell and Pottstown, PA)

i
n Montgomery County
, PA
(suburban Philadelphia
) with
over 16
,000 credit students. The campuses are home to several technology programs,
including biotechnology, engineering technolog
y, and computer science
.
The
existing
biotechnology
programs at MCCC
wil
l be expanded and enhanced due to participation in
this grant project. MCCC offers three degree programs in biotechnology for students to
choose from: A.S. in Biotechnology

(designed for transfer)
, A.A.S in Biotechnology

(designed for career track)
, and A
.A.S. in Biotechnology, Na
nobiotechnology option.
These three

degree granting programs have biotechnology
-
specific courses in common,
which are:

BIT 120, Introduction to Biotechnology

BIT 123, Basic Techniques and Instrumentation for Biotechnology

BIT 220
, Biotechnology Research

BIT 230, Biotechnology Manufacturing

BIT 298
,

Bio
technology Internship (recommended
for A.A.S. degree only)


Key related courses included in the programs
:

At least one semester of majors
-
level Biology

1 or 2 years of Chemistry

Stat
istics


Below is a table of the number of students
enrolled in the biotechnology programs
involved in our
2+2+2 partnerships
, which include two

secondary schools (North Montco
Technical Career Center and Center for Technical Stu
di
es of Montgomery County) a
nd
MCCC (Rehfuss) NBC
2

annual report

Cumulative Sept 05
-
Mar 07

2

three

4
-
year academic partners (
Thomas Jefferson University,
Cabrini College

and
Penn
State
-

Abington
).


Currently
Enrolled
Students

Academic Partner

20

North Montco Technical Career Center

14

Center for Technical Studies of Montgomery County

30

M
ontgomery County Community College

34

Thomas Jefferson University

26

Penn State
-

Abington

10

Cabrini College

134

Total Enrollment

2006
-
07 Academic Year


Large Pharmaceutical Hub Activities

The PA/NJ (and part of
southern NY)
hub
(known as the large Ph
arma hub)
has been
working towards the development of a Qu
ality Control (QC) curriculum for
biochemistry
and microbio
logy job functions. The following report addresses progress made on the
main objectives of the project, including specific delivera
bles. W
hen referring to the
NBC
2

website, the site is
www.biomanufacturing.org
.

1.)
Establish Sustainable Learning Communities around Community College Hubs

MCCC hub partners:

High School / 2
-
year / 4
-
year College

Program Directors/Coordinators




Kevin Lampe, Assistant Professor of Biotechnology, MCCC, Blue Bell, PA



Christopher Harendza, Ph.D., Professor of Biology, MCCC, Blue Bell, PA



Laura McAtee, Ph.D., Instructor of Chemistry, MCCC, Blue Bell, PA



Randy Libros, A
ssociate Professor of Physics, Community College of
Philadelphia, Philadelphia, PA



Kathy Webb, Bucks County Community College, Newtown, PA



Melanie Lenahan, Ph.D., Instructor and Program Director in Biotechnology,
Raritan Valley Community College, Somervill
e, NJ



Laura Anne Roselli, Instructor and Program Consultant for Biotechnology,
Burlington County College, Mt. Laurel, NJ



Lori Dodson, Ph.D., Biotechnology Instructor, North Montco Technical Career
Center, Lansdale, PA



Scott Manz, Biotechnology Instructor,

Center for Technical Studies of
Montgomery County, Plymouth Meeting, PA

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annual report

Cumulative Sept 05
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Mar 07

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Esther E. Biswas
-
Fiss, Ph.D., Associate Professor and Program Director in
Biotechnology, Thomas Jefferson University, Philadelphia, PA



Sheryl L. Fuller
-
Espie, Ph.D., DIC, Associate Pr
ofessor of Biology, Science
Department Chair, Cabrini College, Radnor, PA



Thomas McGuire, Ph.D., Assistant Professor of Biology, Penn State
-
Abington


Industry Collaborators




Thomas Hartnett, P
.E., Sr. Director
,
Johnson & Johnson/McNeil, Ft. Washington,
PA



Joseph P. Lingle, P.E., Director
, Facilities Operations, GlaxoSmithKline, King of
Prussia, PA



Thomas B. Lavoie, Ph.D., Section Head, Protein Biochemistry, PBL Biomedical
Laboratories, Piscataway, NJ



Peter Lowry, Vice President
, Operations, The Immune Respo
nse Corporation,
King of Prussia, PA



Thom
as

Moll, Manager, Fluids Manufacturing Area, Merck and Co., Inc., West
Point, PA



Cynthia Sarnoski, Ph.D.
,

Sr. Vice President, Global Quality Assurance, Wyeth,

Collegeville PA



Richard P. S
chwartz Jr., Ph.D., Presiden
t,
CV Ventures, LLC, Blue Bell, PA


State, Local Government Organizations and Centers




Ron Leonard and Darlene Henry, US Dept. of Labor, Bureau of Apprenticeship
and Training, Philadelphia, PA



Carol Adukaitis,

Ed.D.,

2+2+2 WLG Program Manager, PA State Sy
stem of
Higher Education, Harrisburg, PA



Nadine Lomakin, Director of Programs, Life Science Career Alliance,
Philadelphia, PA


Blogs:

These have been
submitted to the

NBC
2

website in February
2006
and February
2007
summarizin
g current activities at the lar
ge pharma
hub.

Presentations:




The large p
harma hub director
(Dr. Rehfuss)
present
ed updates and progress

reports

at the
a
nnual advisory board meeting September 26
-
28, 2005 and at the
NVC meeting on Mar
ch 3, 2006. At these events, a summary of

the progres
s

made on the curriculum for
QC

Biochemistry and QC Microbiology

(
the two
curriculum topics
for which

the large pharma are
responsible
) was shared with the
committees
. The curricular progress is summarized in #2 of this report.




October 5
-
6. 2006: The NB
C
2

group held its second annual advisory board
meeting

at MCCC.

This meeting was proceeded by a tour of the
biomanufacturing facility at Centocor in nearby Spring House, PA

Other important meetings and events during this time period:

1.

Biotechnology and bio
manufacturing high school summer camp, June
2006

2.

NBC
2

leadership team meeting at Wye Conference C
enter
,

June 2006

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annual report

Cumulative Sept 05
-
Mar 07

4

3.

BIOMAN conference July 2006



Linda Rehfuss and Sheila Byrne
conducted a workshop on the LAL endotoxin endpoint assay.

4.

Linda Rehfuss presented

the NBC
2

goals and objectives to the Penn State
Integration conference in November 2006

Upcoming important dates

in the hub through June 2007
:



Biomanufacturing session, co
-
chaired

Thomas Burkett and Linda Rehfuss, at
the American Chemical Society’s Mid
-
At
lantic Regional Meeting, May 16
-
18, 2007. For more details of this session, visit
www.marmacs.org




NBC
2

biomanufacturing teacher workshop, to be held at MCCC June 7
-
8,
2007



Third annual biot
echnology and biomanufact
uring camp

for high school
students, to be held June 18
-
21, 2007


The following is a summary of events and activities that have been synergistic with the
hub, industry and academic partners:


1. Tour of Centocor during NBC
2

advisory board meeting in Octobe
r
.

2. Work with

Cecil Community College in MD with starting their program
.

3. Assisted

Melanie Lenahan at Raritan Valley College with syllabi, etc.

4. Assisted

Center for Technical Studies develop their program
.

5. Joe Lingle from GlaxoSmithKline and Peter

Lowry from the Immune Response
Corporation met with the four school District superintendents, Linda Rehfuss, President
Karen Stout and other members of the College community to discuss bringing
biotechnology and biomanufacturing into their school district
s at all grade levels.

6. In kind equipment donations have come from Sanofi
-
Aventis, Bristol
-
Myers Squibb
and Emerson Resources.

7. Merck & Co., Inc. has contacted MCCC to consider a partnership to develop an
Aseptic Awareness training program for new and
incumbent workers in the Vaccine
Division of Merck.

8. Laura Ginsberg from the U.S. Department of

Labor spoke at the October 2006

NBC
2

advisory board meeting about establishing apprenticeship programs for
biomanufacturing.


2.)
Develop Biomanufacturing Cur
ricula and Instructional Materials




An action plan
to develop curricula and instructional materials
for the large
Pharma hub was dev
eloped and submitted in February 2006 to the NVC for their
review
.
The complete ac
tion plan can be found on the
NBC
2

websit
e
. The action
plan is

summarized here. The action plan for the development of QC curriculum
has the

following 5 objectives
: 1).

d
emonstrate knowledge of the role of QC in
the organization of a biopharmaceutical company, in particular, how QC functions
fit
within the organizational structure of a company;
2).

d
evelop, read and follow
a Standard Operating Procedure (SOP);
3).

f
ollow an SOP to gain proficiency in
the operation of the following basic laboratory instruments: top loading and
analytical balances,
micropipettes, pH meters and spectrophotometers;
4).

g
ain
expertise in electrophoresis, especially polyacrylamide gel electrophoresis;
5).

d
emonstrate hands
-
on expertise in one or more of the following microbiological
tests: proficiency with aseptic techni
que; gel clot method or chromogenic ass
ay
for endotoxin contamination,
API strip m
icrobiological identification and
MCCC (Rehfuss) NBC
2

annual report

Cumulative Sept 05
-
Mar 07

5

b
ioburden testing. Pre
requisites include basic math s
k
ills, computer sk
ills, at least
one semester of general c
hemistry and familiarization

with microbiological terms
and concepts. The primary goal for the curriculum development is to package and
refine pre
-
existing QC curriculum into education modules t
hat offer laboratory
SOPs

and didactic material, in the form of PowerPoint presentations
and teacher
notes. The following topics will be the focus for the curriculum development:


QC
Microbiology

Planned Modules



Endotoxin Testing


Gel clot method



Chromogenic assay (individual tube format and 96 well plate format)



both



endpoint and kinetic assays



Bioburden Testing


Millipore systems for filtration of air and water


RODAC plates and colony counts



Microbial Identification


Gram stain


API strips



Mycoplasma Testing



PCR test



Environmental Monitoring


Air sampling


Microbiological sampling


QC
Biochemistry

Planned Modules



Use of common laboratory equipment


Balances


Conductivity meter


Micropipettes



pH Meter


Spectrophotometers



Identity/Purity/Potency Testing


Total DNA


SDS PAGE


ELISA



HPLC



Western Blot analysis


Concentration Measurement
-

A
280

measurement


Module #1
,

comp
leted June 2006
:
presented at BIOMAN 2006, in Portsmouth, NH was
an LAL endotoxin endpoint assay. Full module details available on
www.biomanufacturing.org
.

Module #2, completed October 2006
:

Microbiologic

air sampling

SOP, to be presented
at the Jun
e teacher workshop and at BIOMAN 2007

Module # 3, completed January 2007:

Air particle

sampling, to be presented at the June
teacher workshop and BIOMAN 2007

Modules near completion (estimated completion April 2
007 (with planned presentations
at the June teacher workshop and BIOMAN 2007)



PCR mycoplasma test



Environmental monitoring

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annual report

Cumulative Sept 05
-
Mar 07

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Bacterial identification

3).
Provide Professional Development Opportunities in Biomanufacturing for
Faculty



Several companies are con
tributing or have already contributed to the
existing

biotechnology program at MCCC
, including equipment and supply procurement.
Contributions
to MCCC’s biotechnology program
from Bristol
-
Myers Squibb,
Aventis
Pharmaceuticals
and Emerson Resources total m
ore than $50,000 of
equipment donations.
In addition, BMS made an equipment donation to North
Montco Technical Career Center, one of MCCC’s secondary education partners.
Other companies
contributing

to the
development of
hub resources include
Merck, Glaxo
SmithKline and Wyeth.



The hub
conduct
ed

a biotech/biomanufacturing high school workshop (paid for by
state
grant
funds

from the PA Dept. of Community and Economic Development
)
in

late June 2006.
The large Pharma hub plans to host faculty workshops during
t
he summers of 2007, 2008 and 2009.



Dr. Rehfuss and
one
of the grant’s
se
nior personnel (Ms. Roselli) have

almost two
decades of work experience in the pharmaceutical setting,
bringing that
knowledge and skill base to the curriculum development.

4).
Collect

and
Disseminate Biomanufacturing Education and Training and
Workforce Information

Much of the dissemination activities are listed under goal #2. Some of the points listed
below give more detail to some of the topics covered under goal #2.



Dr. Rehfuss
pre
sented the project

to the
Pennsylvania
Dept. of Community and
Economic Development’s annual

meeting on March

1, 2006. The audience
included high
school, community college and 4
-
year college faculty and
administration from across PA. Several members were
eager to learn more about
the curriculum as it is developed for adoption into their various programs.



The first module developed for the program will be the Limulus
amebocyte lysate
(LAL)
chromogeni
c end point assay was

field
-
tested at BIOMAN 2006 in July.

The concurrent modules being developed are the Mycoplasma PCR test (Ms.
Roselli) and the microbiological
identification

tests

(Dr. Lenahan). All 3 of these
modules will be tested at the faculty workshop, to b
e held at MCCC during June
2007 and introduce
d into the grant participants


curriculum during the 2006
-
2007
academic year.




Several members of the
NBC
2

group attended
the

BIO 2006 in Chicago
.




Dr. R
ehfuss presented at
the Penn State Education Integration Conference at Penn
State University November
6
-
7.

The presentation topic was entitled

2+2+2
Pipeline in Biotechnology: Building a Network of Education and Industry
Partners from Local to Regional and Beyond
. She will present the work done by
the NBC
2

group.



To find out all the information about the
current programs, courses and
biotechnology facts at MCCC, you can visit
http://faculty.mc3.edu/lrehfuss/lrehfuss.htm


MCCC (Rehfuss) NBC
2

annual report

Cumulative Sept 05
-
Mar 07

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5).
Build Biomanufacturing Infrastructure Capacity and Self
-
Sufficiency



MC
CC has signed and execute
d articulation agreements with two

secondary

schools (North Montco Technical Career Center and Center for Technical Studi
es
of Montgomery County) and three

4
-
year institutio
ns (Thomas Jefferson
University,
Cabrini College

and Penn
State
-
Abington
). In total, there are over
100 s
tudents in the pipeline at the six (6)

participating institutions of the 2+2+2
agreements. At least 15 credits of advanced standing are available from the
secondary level to MCCC, and students transferring f
rom MCCC to the 4
-
year
institutions do so as juniors.
MCCC
is currently pursing a new articulation
partner, West Chester University. West Chester University offers a B.S. degree in
Pharmaceutical Product Development.
The addition of new partners and upd
ating
existing articulation agreements will hel
p sustain the programs over time, building
a strong pipeline of students who are ready to enter the workforce.



The companies where MCCC biotechnology and biomanufacturing students have
either participated in a
n internship or acquired employment include:



Emerson Resources



National Medical Services



Puresyn



The Immune Response Corporation



BioSante Pharmaceuticals



Centocor

RESOURCES TO SUPPORT QC MATERIALS:

__________________________________________________________
______________

General FDA Web Site





________________________________________________________________________

U.S. Pharmacopeia



________________________________________________________________________

Bio
-
link Web Site
-

Curriculum Clearinghouse


MCCC (Rehfuss) NBC
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annual report

Cumulative Sept 05
-
Mar 07

8



LINKS TO SPECIFIC FD
A DOCUMENTS THAT DIS
CUSS QUA
LITY CONTROL:




Guidance for Industry for Phase 1 Trials



Guide for Inspection of Microbiology QC Lab



Inspection Guide for Quality Control
-

General