Northern New England Hub - Northeast Regional Biomanufacturing ...

jamaicanabsorbingBiotechnology

Dec 5, 2012 (4 years and 11 months ago)

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Northern New England Hub

Job Focus on Facilities, Metrology
and Process Development

New Collaborators


NH BET at
NHCTC and NBC
2


Elizabeth Ehrenfeld, Southern Maine CC at
South Portland, MA


Shahira Badran, Bunker Hill CC at Boston, MA


Mount Wachusetts CC and Bristol
-
Myers
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


Continuing Collaborations


NH
BET at NHCTC and NBC
2


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
College, Winston
-
Salem, NC


John Balchunas and Kathleen Kennedy, Ph.D.,
North Carolina Biotechnology Center, Research
Triangle Park, NC


Dover HS


NH BET at NHCTC
Collaboration


Fall 2007


Three Dover HS students took BTEC 223:
Externship in the NH BET Center under the tutelage of
Eszter Birck
-
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.


Spring 2008


Continuation of BTEC 223 with Dover HS


Fall 2008


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.



Dover HS


NH BET at NHCTC
Collaboration, continued


The junior year course, offered for the first time in
2008
-
2009 in the NH BET Center at NHCTC, will be the
Northeast Biomanufacturing Center and
Collaborative’s BIOMAN Overview prepared by Co
-
PI
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
-
line or
by telephone.

UNH COLSA
-

NHCTC Collaboration
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.

UNH COLSA
-

NHCTC Collaboration


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
ANSCI 651.


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
-
sustainability.




Relationship between

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
much success.


We have quite a few technicians from Lonza
taking our cornerstone courses and either a
Biotechnology Certificate or Associate in Science
degree.

Harmonization of Skill Standards

Indianapolis, Indiana


Focus on Upstream and Downstream Processing and Quality
Control Microbiology and Biochemistry instructional
materials/jobs = Core Production System.


Integrate EH&S and
cGMP

(QA) knowledge and skills into Core
Production System.


Integrate Validation knowledge and skills into Core Production
System.


Integrate Facilities/Metrology knowledge and skills into Core
Production System.


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
cGMPs


Monitor, maintain and repair process or laboratory
equipment


Monitor, maintain and repair plant utility systems


Calibrate control system components


Maintain control systems, equipment and
instrumentation


General engineering technology and maintenance skills


Facilities

Create a Biopharmaceutical Manufacturing Facility
on 2
nd

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
to another.


Practice transferring equipment and personnel
from one area to another as per requirements.


Identify plant utilities to major equipment.



Metrology

March 13, 2006 Thirty percent of liquid delivery
devices are operating out of specification at any
given moment. resulting in false data, wasted
reagents, non
-
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

and Precision

ARTEL Study Shows that Pipetting Warm and Cold Liquids

Causes Error of up to 37 Percent

Example Operation SOP (12)

Calibration


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
biologics


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

Calibration Metrology


System approach


Monitor Verify Validate


Periodic maintenance


Periodic calibration


SOP


Documentation


Traceability


The Real Problem


Wear


Misuse


Hands on component


Calibration of pH meter


Calibration of the balance scale


Calibration of pipette


Calibration Air sampler



Process Development


Process Research


Production of Pre
-
Clinical Animal Trial Material


Large
-
Scale Production of Increasing Amounts of
Phase I, II, and III Clinical Human Trial Material


Post
-
Launch Process Development of
Commercial Material

Process Development


Short course focused on the parameters used in
scale
-
up, both for upstream and downstream
processing.


Use
Pichia pastoris
secreting Human Serum Albumin
to demonstrate these parameters.


We already scale
-
up
Pichia
to a 3 liter process
-
controlled New Brunswick Scientific bioreactor .


Centrifuge and TFF the 3 liter batch.


Demonstrate scale
-
up parameters using 25ml and 2
liter columns already on hand plus SDS
-
PAGE.


Write up procedure for a two day short course (total
of 16 hours for lecture and hands
-
on activities).


Downstream Processing


Purification
Design

Resources for Purification Design
:



Lecture and Virtual Lab


"
Protein

Lab", by A.G. Booth,
School of Biochemistry
and Biotechnology
, University of Leeds, Leeds,
United Kingdom.




Real Process Development Scenarios from
our “
InnovaBIO
” Projects

Stacia Sower, UNH Researcher, Sea Lamprey
Gonadotropin

Scale
-
Up Project:

1.
Tech Transfer of project from UNH to NH BET at
NHCTC.

2.
Description of CHO cell scale
-
up to 2 liter
working volume in
Applikon

process
-
controlled
bioreactors.

3.
Description of purification scale
-
up and
evaluation using SDS
-
PAGE.

4.
Overview of results.