Annual Report - Northeast Biomanufacturing Collaborative

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

1






Northeast Biomanufacturing Center and Collaborative (NBC
2
)

Large Pharma (PA/NJ and southern NY) Hub Annual Report

September 2005
-
February 2008


Introduction

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

grant
#0501953), the g
oal of the Northeast Biomanufacturing Center and Collaborative (NBC
2
)
is to form a self
-
sustaining alliance of community colleges working in collaboration with
industry, education, state agencies and government to assist in the training of a 21
st

century b
iotechnology 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
) in Montgomery County, PA (suburban Philadelphia) with
over 16,000 credit students. The campuses are home to several technology programs,
including biotechnology, engineering technology, and computer science. The existing
biotechnology programs at MCCC
will 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), an
d A.A.S. in Biotechnology, Nanobiotechnology 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

S
tatistics


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
Studies

(
recently

renamed Ce
ntral

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

2

Montco Technical High School)

and four 4
-
year academic partners (Thomas Jefferson
University, Cabrini College,
Penn State
–

Abington and West Chester University).



Currently
Enrolled
Students

Academic Partner

23

North Montco Technical Career Cente
r

16

Central Montco Technical High School


30

Montgomery County Community College

29

Thomas Jefferson University

30

Penn State
-

Abington

9

Cabrini College

14

West Chester University

151

Total Enrollment 2007
-
08

Academic Year


Large Pharmaceutical H
ub Activities

The PA/NJ (and part of southern NY) hub (known as the large Pharma hub) has been
working towards the development of a Quality Control (QC) curriculum for biochemistry
and microbiology job functions. The following report addresses progress ma
de on the
main objectives of the project, including specific deliverables. When referring to the
NBC
2

website, the site is
www.biomanufacturing.org
.

1.) Establish Sustainable Learning Communities around Com
munity 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, Associate Professor of Physics, Community College of
Philadelphia, Philadelphia, PA



Kathy Webb, Bucks County Community College, Newtown, PA



Melanie Lenahan, Ph.D., Instructor and Pr
ogram Director in Biotechnology,
Raritan Valley Community College, Somerville, 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

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

3



Scott Manz, Biotechnology Instructor,
Central Montco Technical High School,

Plymouth Meeting, PA



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



Sheryl L. Fuller
-
Espie, Ph.D., DIC, Associate Professor of Biology, Cabrini
College, Radnor, PA



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



Stephen Ziminski,
PhD.
, Program Director for Pharmaceutical Product
De
velopment, West Chester University, West Chester, PA


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



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



Peter Lowry, Vice President, Operations
, Orchestra Therapeutics, King of Prussia,
PA



Cynthia Sarnoski, Ph.D., Sr. Vice President, Global Quality Assuranc
e, Wyeth,
Collegeville PA



Richard P. S
chwartz Jr., Ph.D., President,
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 System 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 Februar
y 2006, February 2007,
and February 2008

summarizin
g current activities at the large pharma
hub.


Presentations:



The large p
harma hub director (Dr. Rehfuss) presented updates and progress
reports at the annual advisory board meeting September 26
-
28, 2005

and at the
NVC meeting on March 3, 2006. At these events, a summary of the progress
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 NBC
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



Dr
. Rehfuss gave a presentation
entitled Novel

Approaches to Biotechnology
Training at

Community Colleges

at a session at BIO in May 2007.

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

4


Other important meetings and events during this time period:


1.

Biotechnology and biomanufacturing high school summer

camp, June
2006
and June 2007

2.

NBC
2

leadership team meeting at Wye Conference C
enter
,

June
2006 and

November 2007

3.

BIOMAN conference July 2006
–

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

4.

BIOMAN conference July
2007
-

Linda Rehfuss, Kevin Lampe, Melanie
Lenahan, Laura Anne Roselli and Sheila Byrne conducted a quality
control toolbox workshop.

5.

Linda Rehfuss presented the NBC
2

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

6.

Linda Reh
fuss and Thomas Burkett co
-
chaired a Biomanufacturing
session at the American Chemical Society’s Mid
-
Atlantic Regional
Meeting, May, 2007
.

7.

NBC
2

biomanufacturing teacher workshop, held at MCCC
June,

2007

8.

Linda Rehfuss, Kevin Lampe, Dr. Karen Stout, the Pres
ident of MCCC,
and Dean Foster,
Vice President

and Chief Administrative

Officer

of
MCCC West Campus met with area high school principals to discuss

teacher

training workshops on bringing Biotechnology/Biomanufacturing
int
o high school science courses,

Aug.

2007.

9.

Kevin Lampe has had numerous outreach meetings with teachers and
students at area high schools to introduce them to
Biotechnology/Biomanufacturing.

10.

Opening of MCCC Advanced Technology Center including new
Biotechnology/Biomanufacturing Laboratory an
d Tissue Culture Suite,
September 2008.


Upcoming important dates in the hub through July 2008
:



Fourth annual biotechnology and biomanufacturing camp for high school
students, to be held June , 2008



BIOMAN conference to be held at Montgomery County Communi
ty College
July 13
-
17 2008


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 October
, 2006
and teacher

workshop in June 2
007.

2. Work with Cecil Community College in M
D 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 Pet
er Lowry from

Orchestra Therapeutics

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 districts at al
l grade levels.

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

5

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

Emerson

Resources and in 2007 from

Centocor and Biorexis.

7. Merck & Co., Inc. had

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

As of Jan. 2008 this activity is on hold and a similar activity is being
investigated with Tengion.

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

Labor spoke at the October 20
06

NBC
2

advisory board meeting about establishing apprenticeship programs for
biomanufacturing.



2.) Develop Biomanufacturing Curricula and Instructional Materials




An action plan to develop curricula and instructional materials for the large
Pharma hub w
as developed and submitted in February 2006 to the NVC for their
review. The complete action plan can be found on the NBC
2

website. The action
plan is summarized here. The action plan for the development of QC curriculum
has the following 5 objectives
: 1)
.

demonstrate 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).

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

follo
w 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).

gain
expertise in electrophoresis, especially polyacrylamide gel electrop
horesis;
5).

demonstrate hands
-
on expertise in one or more of the following microbiological
tests: proficiency with aseptic technique; gel clot method or chromogenic assay
for endotoxin contamination, API strip microbiological identification and
bioburden
testing. Prerequisites include basic math skills, computer skills, at least
one semester of general chemistry and familiarization with microbiological terms
and concepts. The primary goal for the curriculum development is to package and
refine pre
-
existi
ng 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 endpoint assay (individual tube format and 96 well plate format)



Environmental Monitoring/Bioburden Testing


Air sampling, particle counting and Millipore Air Sampler for ba
cteria


RODAC plates and colony counts



Microbial Identification


Gram stain


API strips



Mycoplasma Testing
–

PCR test





MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

6


QC Biochemistry Planned Modules



Use of common laboratory equipment


Balan
ces

(Note: Some of these modules have been or are


Conductivity meter

being developed with other hubs.)


Micropipettes


p
H

Meter


Spectrophotomete
rs



Identity/Purity/Potency Testing


Total DNA


Total Organic Carbon



HPLC


Concentration Measurement
-

A
280

measurement


PCR test for host cell contamination


Module #1, completed 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
, presented

at the
June 2007
teacher workshop and at BIOMAN 2007

Module # 3, completed January 2007:

Air particle sampling SOP, presented at the June
2007 teacher workshop and BIOMAN 2007

Module # 4, completed MAY 2007:

PCR mycoplasma
test,

presented at the June 2007
teacher workshop.

Endotoxin testing gel clot method presented at BIOMAN 2007.
Bacterial identification Gram stain and API strip SOP presented at June 2007 teacher
workshop and at BIOMAN 2007.


Modules near completion (estimated completion April 2008 (with planned presenta
tions
at and BIOMAN 2008)



Protein Methods (Spectrophotometric, HPLC)


3). Provide Professional Development Opportunities in Biomanufacturing for
Faculty



Several companies are contributing 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 more than $50,000 of
equipment donations. In addition, BMS made an equipment d
onation to North
Montco Technical Career Center, one of MCCC’s secondary education partners.
Centocor and Biorexis have contributed supplies which we are making available
to our secondary education partners. Other companies contributing to the

development
of hub resources include Merck, GlaxoSmithKline and Wyeth.



The hub conducted a biotech/biomanufacturing high school camp (paid for by
state grant funds from the PA Dept. of Community and Economic Development)
in June

2006 and 2007. The large Pharma hub hos
ted a faculty workshop during
the summer of 2007, and plans to host one in 2009.

.

MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

7



Dr. Rehfuss and one of the grant’s senior personnel (Ms. Roselli) have almost two
decades of work experience in the pharmaceutical setting, bringing that
knowledge and skill

base to the curriculum development.



The hub will be hosting BIOMAN in July 2008

4). Collect and Disseminate Biomanufacturing Education and Training and
Workforce Information

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



Dr. Rehfuss
presented 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 d
eveloped for the program,

the Limulus
ameboc
yte lysate (LAL)
chromogenic end point assay
,

was fie
ld
-
tested at BIOMAN 2006
.
The
Mycoplasma

PCR test
module
(Ms. Roselli)

was

tested at the faculty workshop
held at MCCC during June 2007
and the microbiological ide
ntification tests
module (Dr. Lenahan)
were field
-
tested at the 2007 teacher workshop and at
BIOMAN 2007.



Several members of the NBC
2

group attended the BIO 2006 in Chicago and BIO
2007 in Boston.



Dr. Rehfuss presented at the Penn State Education Integration Conference at Penn
State Universi
ty 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 informatio
n about the current programs, courses and
biotechnology facts at MCCC, you can visit
http://faculty.mc3.edu/lrehfuss/lrehfuss.htm


5). Build Biomanufacturing Infrastructure Capacity and Self
-
Su
fficiency



MCCC has signed and executed articulation agreements with two secondary
schools (North Montco Technical Car
eer Center and Central Montco Technical
High School
) and

since 2007 MCCC has students participating in dual
-
credit
enrollment with our seco
ndary partners.
MCCC has signed and executed
articulation agreements with

three 4
-
year institutions (Thomas Jefferson
University, Cabrini College

and Penn State
-
Abington
). In total, there are over
100 students 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 from MCCC to the 4
-
year
institutions do so as juniors. MCCC is
currently completing an

articulation
a
greement with a new partner, West Chester University. West Chester University
offers a B.S. degree in Phar
maceutical Product Development.

The addition of

new partners and updating existing articulation agreements will help sustain the
MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

8

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 an internship or acquired employment include:



Emerson Resources



National Medical
Services



Puresyn



The Immune Response Corporation



BioSante Pharmaceuticals



Centocor



Orthovita



Integral Molecular



Merck & Co.


















MCCC (Rehfuss)
NBC
2

annual report

Cumulative Sept 05
-
Feb 08

9

RESOURCES TO SUPPORT QC MATERIALS:

________________________________________________________________________

General FDA Web Site





________________________________________________________________________

U.S. Pharmacopeia



________________________________________________________________________

Bio
-
link Web Site
-

Curriculum Clearinghouse




LINKS TO SPECIFIC FD
A DOCUMENTS THAT DIS
CUSS QUALITY CONTROL
:




Guidance for Industry for Phase 1 Trials



Guide for Inspection of Microbiology QC Lab



Inspection Guide for Quality Control
-

General