Northern New England Hub
Job Focus on Facilities, Metrology
and Process Development
NH BET at
NHCTC and NBC
Elizabeth Ehrenfeld, Southern Maine CC at
South Portland, MA
Shahira Badran, Bunker Hill CC at Boston, MA
Mount Wachusetts CC and Bristol
Squibb at Devens, MA
Libby Handel, Palm Beach CC, Palm Beach, FL
Shengyong Lee, Ivy Tech CC, Bloomington, IN
Jim Amara, Dover HS, Dover, NH
BET at NHCTC and NBC
Elaine Johnson, Ph.D., Executive Director of the
NSF ATE Center, Bio
Link, Community College of
San Francisco, San Francisco, CA
Russ Read, Executive Director of the DOL ETA
National Center for the Biotechnology
Workforce, Forsyth Technical Community
John Balchunas and Kathleen Kennedy, Ph.D.,
North Carolina Biotechnology Center, Research
Triangle Park, NC
NH BET at NHCTC
Three Dover HS students took BTEC 223:
Externship in the NH BET Center under the tutelage of
Wilson, Ph.D. After learning basic
biotechniques with our lab assistants, the students
worked on our sea lamprey gonadotropin process
development project for UNH academic researcher,
Stacia Sower, and her graduate student, Geoff Bushold.
Continuation of BTEC 223 with Dover HS
Continuation of BTEC 223 with Dover HS plus
the beginning of a 5 year collaboration with Dover HS
where we will offer a junior and a senior course leading
to a 10 college credit Biomanufacturing Certificate.
NH BET at NHCTC
The junior year course, offered for the first time in
2009 in the NH BET Center at NHCTC, will be the
Northeast Biomanufacturing Center and
Collaborative’s BIOMAN Overview prepared by Co
and Hub Director, Mary Jane Kurtz and faculty and
teachers from Middlesex CC in Lowell, Mass Bay CC in
Newton and Minuteman Regional HS. NHCTC will
pilot the course and provide feed back to the Metro
Boston/Cambridge MA/CT Hub. Dr. Kurtz has
promised to provide guidance in person and on
re: Simultaneous Enrollment
We are working with the new Dean of the
College of Life Sciences and Agriculture to
develop a simultaneous enrollment plan where
NHCTC Biotechnology Associate in Science
degree graduates, with a certain GPA, would
automatically be granted junior status at UNH
and would move seamlessly to UNH from NHCTC.
The plan is to have the agreement in place by Fall
2008 and much publicity surrounding the signing
of the agreement by the two presidents.
Simultaneous Enrollment, continued
Reminder: UNH COLSA and Chemical Engineering
majors already reverse articulate into our Industrial
Biotechnology cornerstone courses, BTEC 210:
Discovery Research and BTEC 220: Biomanufacturing.
NHCTC’s BTEC 210 = UNH’s MICRO 655 and ANSCI
655; NHCTC’s BTEC 220 = UNH’s MICRO 651 and
This collaboration will do much to create the
infrastructure for biomanufacturing education and
training and the workforce for New Hampshire and
can act as a model for other locales.
Relationship between NHCTC’s
Biotechnology program and Lonza
continues to be a great model:
Lonza will pay a $1500 finders fee for NHCTC student hired at
Lonza (after three months at Lonza).
Lonza will hire 2
3 Apprentices each summer (apprentices are
from high schools with biotechnology programs and courses).
Lonza will interview graduates for jobs at NHCTC in
November/December and April/May.
Lonza worked with NHCTC Biotechnology faculty and staff to
create the popular Aseptic Techniques course and we have put
236 Lonza technicians and others through the course to date.
Lonza has used our Biomanufacturing Seminar, as well. The
Northeast Biomanufacturing Institute is a model for self
NHCTC’s Biotechnology program and Lonza
continues to be a great model:
We tried alternative scheduling of BTEC 220:
Biomanufacturing for Lonza employees with out
We have quite a few technicians from Lonza
taking our cornerstone courses and either a
Biotechnology Certificate or Associate in Science
Harmonization of Skill Standards
Focus on Upstream and Downstream Processing and Quality
Control Microbiology and Biochemistry instructional
materials/jobs = Core Production System.
Integrate EH&S and
(QA) knowledge and skills into Core
Integrate Validation knowledge and skills into Core Production
Integrate Facilities/Metrology knowledge and skills into Core
Create separate course in Maintenance/Instrumentation to
cover knowledge and skills for Facilities and Metrology jobs.
Create Process Development short course for incumbent
workers and students in our programs.
Maintenance and Instrumentation
Key Job Functions:
Work in compliance with EH&S
Work in compliance with
Monitor, maintain and repair process or laboratory
Monitor, maintain and repair plant utility systems
Calibrate control system components
Maintain control systems, equipment and
General engineering technology and maintenance skills
Create a Biopharmaceutical Manufacturing Facility
Life for the purpose of introducing
students to the layout of such a facility.
Understand how equipment and personnel flow
and the requirements for moving from one area
Practice transferring equipment and personnel
from one area to another as per requirements.
Identify plant utilities to major equipment.
March 13, 2006 Thirty percent of liquid delivery
devices are operating out of specification at any
given moment. resulting in false data, wasted
compliance and costly remedial action.
July 17, 2007 Pipettes deliver volumes inaccurate by up
to 37 percent when handling fluids at temperatures
different from the pipettes.
Called thermal disequilibrium, this source of error is
prevalent in today’s laboratories.
ARTEL: LDQA Service Suite to Improve Liquid Handling Accuracy
ARTEL Study Shows that Pipetting Warm and Cold Liquids
Causes Error of up to 37 Percent
Example Operation SOP (12)
21 CFR Part 58 : Good Laboratory Practices (GLP)
21 CFR Part 211: Good Manufacturing Practices
(GMP) for pharmaceuticals
21CFR Part 606: Good Manufacturing Practices for
21 CFR Part 820 : Quality Systems Regulations
Failed or irreproducible trials
Risk of citations
Shut down for regulatory violations
Poor calibration management
Minimizing Calibration Risk in complex Biotech Environmants
Monitor Verify Validate
The Real Problem
Hands on component
Calibration of pH meter
Calibration of the balance scale
Calibration of pipette
Calibration Air sampler
Production of Pre
Clinical Animal Trial Material
Scale Production of Increasing Amounts of
Phase I, II, and III Clinical Human Trial Material
Launch Process Development of
Short course focused on the parameters used in
up, both for upstream and downstream
secreting Human Serum Albumin
to demonstrate these parameters.
We already scale
to a 3 liter process
controlled New Brunswick Scientific bioreactor .
Centrifuge and TFF the 3 liter batch.
up parameters using 25ml and 2
liter columns already on hand plus SDS
Write up procedure for a two day short course (total
of 16 hours for lecture and hands
Resources for Purification Design
Lecture and Virtual Lab
Lab", by A.G. Booth,
School of Biochemistry
, University of Leeds, Leeds,
Real Process Development Scenarios from
Stacia Sower, UNH Researcher, Sea Lamprey
Tech Transfer of project from UNH to NH BET at
Description of CHO cell scale
up to 2 liter
working volume in
Description of purification scale
evaluation using SDS
Overview of results.