NSF Site Visit - Northeast Biomanufacturing Collaborative


Feb 20, 2013 (5 years and 4 months ago)


Montgomery County Community College

Blue Bell, PA

Large Pharmaceutical Hub


NVC meeting

February 16, 2007

QC Biochemistry

QC Microbiology

New Advanced Technology Center

Target Open Date: Fall 2007

Square Footage: 62,000


sq. ft. lab and separate tissue culture

2nd biotech lab available

looking for
incubator partnership

Diagram of New Advanced
Technology Center

Biotechnology Education

Programs offered since Fall 2002

2 Biotechnology programs

A.S., designed for transfer

A.A.S., career track (internship in 4


A.A.S. in Biotechnology, Nanobiotechnology
option (4

semester capstone at Penn State)

5 Biotechnology
specific courses developed

Expanding BIT 230 (Biotechnology
Manufacturing) with NBC


Biotechnology Industry Board

Dr. Cynthia Sarnoski,
Sr.. VP Quality, Wyeth

Peter Lowry, VP
Operations, IMRC

Dr. Thomas Lavoie,
Section Head, PBL
Biomedical Labs

Joe Lingle, Director of
Facilities, GSK

Tom Moll, Manager of
Manufacturing, Merck

Dr. Rick Schwarz,
President, CV Ventures

Thom Hartnett, Sr..
Director, J&J/McNeil

MCCC Hub Personnel

Linda Rehfuss, Ph.D., co
PI/hub Director

Kevin Lampe, M.S. Assistant Professor of
Biotechnology, MCCC

Sheila Byrne, B.S., Project Assistant, MCCC

Laura Roselli, M.S., Biotechnology Instructor
and Program Consultant, Burlington County
College, NJ

Melanie Lenahan, Ph.D., Biotechnology
Assistant Professor and Program Coordinator,
Raritan Valley Community College, NJ

MCCC Hub Job Cluster

QC Biochemistry/Chemistry

Identity testing

Potency testing

Purity testing

QC Microbiology

Microbiological identification

Endotoxin testing



Hub Activities Through 02/2007

LAL endotoxin endpoint assay

workshop at BIOMAN 2006

Hosted Oct. 5
6 Advisory Board Meeting

Presented at Penn
State Integration
Conference about this project

Several regional teleconferences

Working with NMTCC on dual
enrollment for biotech/biomanufacturing

Hub Activities continued

LAL chromogenic assay (Linda and Sheila)

Mycoplasma test (Laura Roselli)

Microbiological Identification (Melanie

Will include SOPs for basic instrumentation
if needed (e.g. balance SOP in SOP for
Mycoplasma test)

Field test each by May/June ’07

(instructor workshop June 7
8, 2007)

Summary of Modules

Module #1, completed June 2006:
presented at BIOMAN 2006, in Portsmouth,
NH was an LAL endotoxin endpoint assay.

Module #2, completed October 2006:

Microbiology count SOP, to be presented at
the June teacher workshop and at BIOMAN

Module # 3, completed January 2007:

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

Module Development

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

PCR mycoplasma test

Environmental monitoring

Bacterial identification

Education Collaborators

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

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

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

Scott Manz, Biotechnology Instructor and Program Development, Center
for Technical Studies of Montgomery County, Plymouth Meeting, PA

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 Professor of Biology, Science
Department Chair, Cabrini College, Radnor, PA

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

Randy Libros, Associate Professor of Physics, Community College of
Philadelphia, Philadelphia, PA

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

Kathy Webb, Dept. of Science and Technology, Bucks County Community
College, Newtown, PA

Industry and Government

Thomas Hartnett, P.E., Sr. Director, J&J /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 Response
Corporation, King of Prussia, PA

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

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

Richard P. Schwartz Jr., Ph.D., President, CV Ventures, LLC, Blue Bell, PA

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

Dr. Carol Adukaitis, 2+2+2 WLG Program Manager, PA State System of
Higher Education, Harrisburg, PA

Joseph Welsh, Executive Director, Collegiate Consortium, Philadelphia, PA

PA Biotechnology Association, Malvern, PA

Action Plan: Curriculum Objectives

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

Develop, read and follow a Standard
Operating Procedure (SOP)

Follow an SOP to gain proficiency in the
operation of the following basic laboratory
instruments: top loading and analytical
balances, micropipettes, pH meters and

Objectives Continued

Gain expertise in electrophoresis,
especially polyacrylamide gel

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; Bioburden

Curriculum Pre

Math skills: college level algebra

Basic computer skills (Word, Excel,

General Chemistry at the level of at least one
semester College course (includes
concentration expressions, pH, acids, bases,

Familiar with microbiological terms and

aseptic technique, gram
and gram
positive bacteria, culturing bacteria,
staining procedures

Curriculum Approach

Pedagogical approach will utilize a
combination of PowerPoint lectures and
teacher notes

Laboratory activities using SOPs as the
primary format for delivery

Each subtopic in the curriculum will have
didactic instructional materials and a
laboratory SOP for that specific task

Equipment Needs

Analytical and top loading balances

pH meter

UV/visible spectrophotometer

p20, p200, and p1000 micropipettors

UV transilluminator

Multichannel pipettors

Repeat pipettors


Incubating heating blocks (for 96
well plates)

Electrophoresis equipment, including gel boxes (vertical and horizontal),
power supplies, and pre
cast gels

Conductivity meters

Electrophoresis chambers and accessories for SDS

BioTek 96 well UV/visible plate reader

Air and water filtration systems

API system for microbial identification

Laboratory Exercises for

Endotoxin Testing

Gel clot method

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


(in development)

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

Laboratory Exercises for

Use of common laboratory equipment


Conductivity meter


pH Meter


Identity/Purity/Potency Testing

Total DNA



Western Blot analysis

Concentration Measurement