NSF Site Visit - Northeast Biomanufacturing Collaborative

whipmellificiumBiotechnology

Feb 20, 2013 (4 years and 8 months ago)

194 views

Montgomery County Community College

Blue Bell, PA


Large Pharmaceutical Hub

NBC
2

NVC meeting

February 16, 2007

QC Biochemistry

QC Microbiology

New Advanced Technology Center


Target Open Date: Fall 2007


Square Footage: 62,000


Biotechnology/biomanufacturing
-

1,000
sq. ft. lab and separate tissue culture
suite


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
th

semester)


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

semester capstone at Penn State)


5 Biotechnology
-
specific courses developed


Expanding BIT 230 (Biotechnology
Manufacturing) with NBC
2

curriculum

Biotechnology Industry Board
Members


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


LAL


Bioburden

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
Lenahan)


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
2007


Module # 3, completed January 2007:

Air
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
Collaborators


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
company


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
spectrophotometers.



Objectives Continued


Gain expertise in electrophoresis,
especially polyacrylamide gel
electrophoresis


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
testing


Curriculum Pre
-
Requisites


Math skills: college level algebra


Basic computer skills (Word, Excel,
PowerPoint)


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


Familiar with microbiological terms and
concepts


aseptic technique, gram
-
negative
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


Thermocycler


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
-
PAGE


BioTek 96 well UV/visible plate reader


Air and water filtration systems


API system for microbial identification


Laboratory Exercises for
Microbiology


Endotoxin Testing


Gel clot method


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

endpoint
(completed)

and
kinetic
(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
Biochemistry


Use of common laboratory equipment


Balances


Conductivity meter


Micropipettes


pH Meter


Spectrophotometers


Identity/Purity/Potency Testing


Total DNA


SDS PAGE


ELISA


Western Blot analysis


Concentration Measurement
-

A
280

measurement