ISPE Breakfast Seminar
January 2008
THE “GMP” CORE LAB –
EXPECTATIONS VS. REALITIES
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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01
02
03
04
05
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Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Presenters
Alan Orton
Principal, NFOE/NXL Architects
Paul Jeanson
Project manager/Compliance Specialist
SNC-Lavalin Pharma
The GMP Core Lab – Expectations vs. Realities
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Presentation structure
• Setting the table – outlining Good
Manufacturing Practice expectations
& regulatory criteria to be addressed
• Looking at four current or recent GMP
laboratories and how they are dealing
with these issues
• Identifying the principal challenges in
planning, designing and constructing,
and operating these facilities
• Lessons learned
The GMP Core Lab – Expectations vs. Realities
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Case studies
• Cell Therapy Centre of Excellence (CETC),
Maisonneuve-Rosemont Hospital, Montreal
• Experimental Tissue Engineering Laboratory
(LOEX), Tissue Engineering & Regenerative
Medicine Centre, CHAUQ / Enfant-Jésus
Hospital, Quebec City
• Veterinary & Food Biotechnology Institute
(LBVA), Faculty of Veterinary Medicine
University of Montreal, St. Hyacinthe
• Connell O’Reilly Cell Manipulation Core
Facility (CMCF), Dana-Farber Cancer
Institute, Boston, Massachusetts
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Why a GMP core lab?
• Upgrading current core lab from
fundamental R&D to GMP safety level
(health risk management)
• Participation in clinical trials – institutional
recognition nationally & internationally
• Absence of alternatives for scale-up or
manufacture of innovative products
• Product commercialization
Allure of benchtop to bedside….
….invention to innovation
The GMP Core Lab – Expectations vs. Realities
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Cultural shift
Moving from the discovery – make
as many errors as fast as you can,
try new methods - mode of
research….
To the delivery - error free,
repeatable, traceable, and highly
documented – mode of product
development & manufacturing
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Changing the way people work
going from flexible & adaptable….
to fixed & restricted….
The GMP Core Lab – Expectations vs. Realities
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01
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03
04
05
06
Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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GMP Means….
• GMP: Good Manufacturing Practices (worldwide)
• « Regulations » which have the force of law in most countries
• Applies to establishments that fabricate, package, label, distribute,
import, wholesale, or test medication. (drugs, blood products &
biologicals). Part of quality assurance which ensure that products,
are consistently produced and controlled to the quality standards
appropriates to their intended use as required by the product
specifications.
• Ensure that products are safe, pure, and effective
• Ensure that drug manufacturing is carried out in safe and
quality processes, to avoid contamination and ensure
repeatability
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Others GxP
• QSR: Quality System Regulation (Medical Devices – FDA).
• MDR: Medical device regulations (HC) and ISO Certification, CE
mark /European Medicines Agency (EMEA)
• GCP: Good Clinical Practices (ICH).
Standard for design, conduct, performance, monitoring, recording,
analyses, and reporting of clinical trials. Provides assurance that the data
and reported results are credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are protected.
GAMP: Good Automated Manufacturing Practices (guidelines)
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Dedicated regulations to core lab compliance…
• GTP: Good Tissue Practices (FDA)
Based on GMP principles applicable to human cells &tissues & cellular &
tissue-based products (HCT/Ps). 21CFR 1270 and 1271.
To prevent the introduction, transmission, or spread of
communicable disease through the use of human cells, tissues,
and cellular and tissues based-products (HCT/Ps).
• CTO: Cells, Tissues and Organs (HC)
Technical requirements to address the safety of Human Cells,
Tissues and Organs for transplantation (Directive and Guidance).
• Laboratory Biosafety Guidelines (PHAC)
• Quality and safety standard for human tissues and cells
(European Parliament and of the Council on ATMPs)
• Guide to safety and quality assurance for organs, tissues and
cells (European Parliament and of the Council on ATMPs)
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Why apply GxP/GMP to an institutional core lab?
• Only guidelines applicable to all human cells &tissues &
cellular & tissues-based products (HCT/P’s), medications
(drugs, blood products & biologicals), medical devices
• Lack of applicable hospital safety regulations
• Only way to have recognized clinical trials and to be part
of international activities
• Unique way to ensure safety of HCT/P’s treated patients
• Provides a method to standardize treatments
• Best way to achieve product quality (safety, purity,
strength, identity, reliability)
ªTo ensure the health and safety of patients
The GMP Core Lab – Expectations vs. Realities
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GTP means (as GMP)…
Components
Process
Equipment
Validation
Routine Monitoring
QA/QC
Environment
GTP
Personnel
Raw materials
The GMP Core Lab – Expectations vs. Realities
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“Validation”: What does it mean?
• A methodology for demonstrating compliance with GXP
requirements
• Testing of 100% of finished product is not feasible (to assure
product quality, representative sample testing is done)
 Validation
Establishing documented evidence which provides a high
degree of assurance that a specific procedure, process,
equipment, material, activity, or system will consistently
produce a product meeting predetermined specifications
and quality attributes.
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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“Validation”: What does it mean for GTP?
Slightly different from GMP Validation expectations…
• Raw materials are constantly changing (Organs, tissues
infectious profiles, quantities)
• Final products are constantly changing
• Where the results of processing … cannot be fully
verified by subsequent inspection and tests, you must
validate and approve the process according to
established procedures.
• Validation activities and results must be documented,
including the date and signature of the individual(s)
approving the validation.
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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“Validation”: What does it mean?
• Validation documentation:
• Validation Master Plan
• Pre-approved protocols for qualification of installation
(IQ), operation (OQ), performance (PQ) of equipment
• Standard Operating Procedures for all critical aspects
of operations – from raw material receipt to release of
final product
• Execution of those protocols
• Reporting of gathered data and results
• Key component of global Quality Control / Quality
Assurance program
The GMP Core Lab – Expectations vs. Realities
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Documentation Lifecycle
Business Plan
Systems:
SOPs, Training, Operations,
Maintenance, Change Control
Engineering
Documents
Process
Definition
Conceptual
Design
Construction
Documents
Purchasing
Document
Commissioning
Documents
Field Tests
Vendor
Documents
Start-up
P&ID’s
FAT
Specification
Drawing
Operation
Documents
Installation
Documents
Validation
Master Plan
Regulatory
Documents
The GMP Core Lab – Expectations vs. Realities
Validation Protocols
IQ Ö OQ Ö PQ
Execute
Validation
Validation
Reports
ISPE Breakfast Seminar – January 2008
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Benefits of Validations…..
• Compliance with applicable
regulations
• Deliver systems that are fit for purpose
• Decrease downtime
• Reduction in rejections and reworks
• Reduced testing for In-process and
finished goods
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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01
02
03
04
05
06
Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Case Study
Cell Therapy Centre of Excellence
(Centre d’Excellence en Thérapie Cellulaire – CETC),
Maisonneuve-Rosemont Hospital, Montreal
Core Lab Analysis – Case Study 1
The GMP Core Lab – Expectations vs. Realities
Project Description - CETC
Overview
• A new core lab to be a Centre of Excellence for
cell therapy treatments in Québec
• Existing laboratory already a leader in autologous
(re-transplant of treated cells to same patient) &
allogeneic (transplants from a different donor) cell
therapy treatments, serving the Quebec health
care network
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Project Description - CETC
Potential products:
• Autologous & allogeneic cell manipulations
for oncology and hematology treatments
• Cartilage cell cultures for autologous
transplants (orthopedic reconstructions)
• Cell treatments for ocular repairs (retinas,
corneas)
The GMP Core Lab – Expectations vs. Realities
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Facility plan - CETC
GMP cell
manipulation
lab suite
The GMP Core Lab – Expectations vs. Realities
GMP cell
manipulation
lab suite
(CL-2)
Lab support
services
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Facility characteristics - CETC
• Net area: 6,530 sq. ft.; gross departmental area:
8,875 sq. ft. (1.36 factor)
• Estimated construction cost (fit-out): $7.2M,
including GST, PST; excluding scientific equipment,
consultancy fees, etc.
• Unit area construction cost : $1,100 / NSF
• Estimated total consultancy fees: 25% of
construction cost (URS/FTP: $80K, A,M&E: $650K, V:
$1,050K)
• Total project cost: n/a
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Key considerations - CETC
• GMP compliance is not a requirement
for present operations – decision to
validate or not
• Participation in multi-centric clinical
trials will be the primary drivers for
eventual GMP compliance
• Justification of high initial capital and
start-up costs
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Key challenges - CETC
• Higher than average validation and
compliance costs, due to the relative
small size of the facility, multiplicity of
small instruments (lab type, not GMP purpose
built), & preparation of protocols & SOP’s
• Staff cost burden during 4-6 month
start-up & validation period
• Training of hospital support staff to
meet continuous monitoring &
compliance requirements
• Securing long term operational funding
support, with a projected staff of 25
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Case Study
Experimental Tissue Engineering Laboratory
(Laboratoire d’Organogénèse Expérimental - LOEX),
Tissue Engineering & Regenerative Medicine Centre,
CHAUQ - Enfant-Jesus Hospital, Québec City
Core Lab Analysis – Case Study 2
The GMP Core Lab – Expectations vs. Realities
Project Description - LOEX
Overview
• A new core lab for the GMP compliant generation of
reconstructive tissue products (tissue-like structures
incorporating living cells for in-vivo or ex-vivo uses)
• Existing laboratory already unique in Canada for tissue
engineering, serving principally the Quebec health care
network
• Core lab component of an academic research centre
(LOEX) within the CHA/Laval University structure
The GMP Core Lab – Expectations vs. Realities
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Project Description - LOEX
Potential products (in vitro cell culture methods):
• Mucosal & skin equivalents (Cutaneous
system)
• Blood vessels (Vascular system)
• Ligaments (Orthopaedic system)
• Bronchial equivalents (Respiratory system)
• Corneal equivalents (Cornea System)
Current products are primarily skin
equivalents intended for autologous
transplantation of reconstructed
epidermis into extensively burned
patients
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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GMP Facility plan - LOEX
Support services: storage,
washing & sterilization
GMP lab
suite
GMP prep &
support
services
The GMP Core Lab – Expectations vs. Realities
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GMP Facility characteristics – LOEX
• Net area: 1,860 sq. ft.; excludes support services
area; gross departmental area: 2,480 sq. ft. (1.28 factor)
• Estimated construction cost (fit-out): $1.0M,
including taxes; excluding scientific equipment,
consultancy fees, etc.
• Unit area construction cost: $535 / NSF
• Estimated consultancy fees: 11.3% of
construction cost ( Architectural/Mechanical/
Electrical only; no process engineering or validation fees
incurred or projected to date)
• Total project cost: not available
The GMP Core Lab – Expectations vs. Realities
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Key considerations - LOEX
• GMP compliance is not a requirement
for present operations
• Participation in international multicentric clinical trails is the primary
driver for eventual compliance
• Not-for-profit facility; fee for service
within Quebec health care network
• High initial capital & start-up costs;
ongoing operating costs to be partly
mitigated by using Hospital services
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Case Study
Veterinary & Food Biotechnology Laboratory
(Laboratoire de Biotechnologie Vétérinaire et Alimentaire (LBVA),
University of Montreal, St. Hyacinthe
Core Lab Analysis – Case Study 3
The GMP Core Lab – Expectations vs. Realities
Project description - LBVA
Overview
• A new core laboratory intended for
the development & production of
innovative veterinary &human
biotherapeutic products
• Core lab facility was integrated into
a new research annex constructed
on the U of Montreal’s Faculty of
Veterinary Medicine campus in St.
Hyacinthe, Quebec
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Laboratory objectives - LBVA
• Development, scale-up and pilot
production of innovative viral and
bacterial vaccines
• Validated, compliant GMP facility for
production of clinical materials, licensing
batches, and small scale commercial runs
• Research & development on new
molecular transport technologies
(adjuvants for diverse products)
• Proprietary product development as well
as projects in partnership with the private
sector
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Facility plan - LBVA
Support services: storage, dispensing,
solution, prep, washing & sterilization
Decon
services
(CL-2LS)
Cell culture
suite
Formulation
& filling
QC lab
Bacterial
fermentation
suite (CL-2LS)
Viral culture
suite (CL-2LS)
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Facility characteristics - LBVA
• Net area: 5,385 sq. ft.; Gross departmental area:
6,975 sq. ft. (1.3 factor)
• Construction cost: $6.1M including GST, PST;
including a prorated portion of base building costs (~15%);
excluding scientific equipment, consultancy fees, etc.
• Unit area cost : $1,125 / NSF
• Global consultancy fees: 30% of
construction cost (PM: $200K, URS&FTP: $85K;
Process Engineering: $250K, A,M&E: $530K, V: $560K)
• Total global project cost: $13.7M (taxes incl.)
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Project timeline - LBVA
• Initial planning &
funding request
1999 – 2000
• Facility programming &
design
Q4-2001 – Q2-2002
• Construction
Q3-2002 – Q3-2004
• Operations team
engaged
Q4-2004
• Business development
staff engaged
Q2-2006
• Validation
Q1-2005 – Q1-2007
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Critical process systems - LBVA
• 10 - 100 litre bioreactors
• 10 - 100 litre fermenters
• Lyophilizer
• Roller deck incubators
• Tangential flow filtration system
• Homogeniser
• Chromatography system
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Key challenges - LBVA
• Business case justification limited to initial
capital investment
• Changes in Faculty management
during project development
• Changes to processes & information
shortfall prior to validation start-up
• Securing funding to complete validation
& achieve operational readiness
• Sustaining initial interest from outside
partners during validation effort
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Lessons learned - LBVA
• Expectations of U of M & project’s
promoters differed – for profit, GMP
operations not a core university activity
• Lab status & operational authority limits
were not clear
• Operations / validation staff were
engaged late in the project
• Insufficient funds were available to
complete GMP compliance effort
• Facility mission is now under review
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Case Study
Connell O’Reilly Cell Manipulation Core
Facility (CMCF) ,
Dana Farber Cancer Institute (DFCI), Boston
Core Lab Analysis – Case Study 4
The GMP Core Lab – Expectations vs. Realities
Project Description - CMCF
Overview
• DFCI core lab since 1996; Harvard Cancer Centre core
facility since 2000
• 1996 laboratory activities were “procedurally compliant”
with regulatory expectations; facility operations were too
small and not to GMP standard
• CMCF provides not-for-profit autologous and allogeneic
cell therapy treatments to patients within the Harvard
Medical Centre and Boston area health care networks
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Project Description - CMCF
Manufactures cellular products for clinical
use:
• Stem cells
• Tumour vaccines
• Immune cells
“CMCF currently supports over 30
clinical trials and process approximately
800 stem cell and immunotherapy
products annually for patients at MGH,
BWH, DFCI and BCH.”
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Regulatory parameters - CMCF
• Design reviews held with the FDA and
with NIH (key funding support)
• Class 10,000 established for both cell
production units following design reviews
• Compliance with US FDA regulations
• FDA Establishment registration obtained
• FACT accredited cell processing lab for
adult stem cell transplantation program
at DFCI/BWH & pediatric stem cell
transplant program at BCH /DFCI
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Overall facility plans
GMP Cell Manufacturing,
Gene Therapy
& support labs
Offices
R&D
Cyropreservation
The GMP Core Lab – Expectations vs. Realities
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Facility characteristics - CMCF
• Net laboratory area: 3,990 sq. ft.;
• Construction cost (fit-out): $3.3M USD;
excluding scientific equipment, consultancy fees,
etc.
• Unit area construction cost: $827 USD
/ NSF
• Estimated consultancy fees: 31% of
construction cost ( Architectural /Engineering
/Validation)
• Total project cost: $5.0M USD
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Project timeline - CMCF
• Initial funding request Q1 - 2000
• Funding approval
Q3 - 2000
• Facility programming
& design*
Q3-2000 – Q4-2002
• Construction
Q1-2003 – Q1-2005
• Validation
Q1-2005 – Q2-2005
* Includes time required to find & renovate space for previous
occupants to be relocated; the costs associated with these
moves are not included in this project’s budget
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Key challenges - CMCF
• Finding & fitting into space was primary
challenge in moving the project forward
• Defining regulatory standards to be met;
integrating FDA & NIH recommendations
during design
• Staffing – recruitment of qualified
manufacturing staff, plus a substantial
increase in training requirements
• Dealing with continuing space shortfall;
limited space for expansion
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Keys to success - CMCF
• Primary objective for GMP compliance was improved patient
safety – facilitated buy-in from DFCI/HCC management
• Operations are supported by both clinical activities &
research funding (~50/50)
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Keys to success - CMCF
• Raising the profile of the CMCF
• Part of the Centre for Human Cell Therapy –
assists PI’s in translating novel cell therapies
from animal models to human applications
• Affiliated with the Harvard Stem Cell Institute
• Collaborates with the Translational Cell
Therapy Laboratory
• Developing projects with investigators from
Brigham & Women’s, Mass General, Boston
Children’s hospitals
• Identifying potential new users of the
laboratory – developing a pipeline of projects
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Lessons learned - CMCF
• Project took longer to complete & cost
more than initially anticipated
• A global vision of activities is essential;
beyond initial financing & start-up
• Feedback from FDA & NIH was crucial
• QC/QA effort & documentation
burden underestimated
• Commitment necessary to build &
grow lab operations – raising profile &
building networks
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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01
02
03
04
05
06
Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Comparison – Laboratory structure & objectives
CETC
LOEX
LBVA
CMCF
Independent entity
No
No
No
No
For profit
No
No
Yes
No
Fee-for-service
Yes
Yes
Yes
Yes
Clinical trials /
external contracts
Maybe
Maybe
Yes
Yes
Capital investment
plan
Yes
Yes
Yes
Yes
Ongoing facility
marketing
Planned
No
Yes initiated
Yes
Formal long term
business plan
No
No
No
No
The GMP Core Lab – Expectations vs. Realities
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Comparison – Project status
CETC
LOEX
LBVA
CMCF
Programming
complete
Yes
Yes
Yes
Yes
Design complete
Feasibility
Study
Preliminary
design
Yes
Yes
Construction
complete
No
No
Yes
Yes
Validation
intended
Maybe
Maybe
Yes
Yes
Validation
complete
n/a
n/a
60%
complete
Yes
GMP compliant
operations
(to be
determined)
(to be
determined)
No
Yes
The GMP Core Lab – Expectations vs. Realities
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Comparison – Facility characteristics
CETC
LOEX
LBVA
CMCF
Net Area - NSF
6,530
2,360
5,385
3,990
Construction cost
$7.2M est.
$1.0M est.
$6.1M*
$3.3M USD
% M&E cost
70%
68%
59%*
n/a
Unit cost $ / NSF
$1,100
$535
$1,125
$827 USD
Consultancy fees %
25%
11%
29%
31%
Total project cost
n/a
n/a
$13.7M
$5.0M USD
Net to building
gross area ratio
0.467
0.542
0.49
n/a
NSF to Building GSF
gross-up factor
2.14
1.85
2.05
n/a
* Includes ~15% allowance for base building costs; % M&E based on global cost
The GMP Core Lab – Expectations vs. Realities
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Comparison – Technical characteristics – building systems
CETC
LOEX
LBVA
CMCF
Environmental
classifications
ISO 8 & 7
ISO 8 & 7
ISO 8 & 7
(ISO 5 Filling)
ISO 7(Class
10,000)
Biosafety
containment level
CL-2
none
CL-2LS
CL-2
Independent
HVAC
Yes
Yes
Yes
Yes
Air change rate
per hour
30-35
30
30 (60 in ISO
5 area)
30
Air circulation
strategy
30-100% nonrecirculated
30% nonrecirculated
15% min.
fresh air
100% nonrecirculated
Air filtration
strategy
Terminal
HEPA filters
Terminal
HEPA filters
Terminal
HEPA filters
Terminal
HEPA filters
Independent BAS
Yes
No-module
of main BAS
No-module
of main BAS
Yes
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Comparison – Technical characteristics - utilities
CETC
LOEX
LBVA
USP water
x
WFI water
x
Clean compressed air
x
CMCF
x
x
Clean steam
x
Laboratory vacuum
CO² distribution
x
x
x
Liquid nitrogen distribution
x
x
x
x
CIP / SIP systems
x
Sterilization autoclave
Decontamination autoclave
The GMP Core Lab – Expectations vs. Realities
x
x
x
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Comparison – Regulatory approach
CETC
LOEX
LBVA
CMCF
URS / Technical
program
Yes
Yes
Yes
Yes
Process flow
diagrams
Yes
No
Yes
Outside validation
consultants
To be
determined
No
Yes
Yes
Validation Master
Plan
To be
determined
To be
determined
Yes
Yes
New SOP’s
prepared
Yes - Existing
modified
SOP’s (Standard
Operating Procedures)
Existing to be
Existing to
modified
be modified
Yes (existing
updated)
Facility validation
To be
determined
To be
determined
Yes - 90%
complete
Yes
Process validation
To be
determined
To be
determined
Yes – 50%
complete
Yes
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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Comparison – Operations
CETC
LOEX
LBVA
CMCF
Anticipated total
staff
25
10
15-30
25-26
Scientific director
Yes
Yes
Yes
Yes
Technical director
To be
determined
To be
determined
Yes
Yes
QC/QA staff
1 currently
1 currently
3
3
Housekeeping
Hospital
services
Hospital
services
In-house lab
staff (start-up)
Outsourced
Building systems
technical support
Hospital
services
Hospital
services
University
services
Institute
services
Metered rates
or by area
Not
charged
Energy costs
Not currently Not currently
charged
charged
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
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01
02
03
04
05
06
Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
The GMP Core Lab – Expectations vs. Realities
ISPE Breakfast Seminar – January 2008
62
Lessons learned – Challenges to aspiring institutions
1. Judging the need to be GMP compliant
- understanding the implications
2. Justifying higher initial costs
3. Managing the paradigm shift in work –
moving from an innovative research to
routine production operations
4. Committing to raising the lab’s profile &
market its services
5. Securing long term funding to maintain
compliant operations
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Why do these labs matter…
1. Help address the invention to innovation
gap in Canada
2. Build bridges between academia and
industry
3. Provides another source to industry for
new products, for trained staff, for pilot
scale or small market production
4. Industry has specific experience &
expertise that academic core labs need
5. Cross fertilization of research activities
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01
02
03
04
05
06
Introduction
GMP & regulatory parameters
Case studies - analysis
Case studies - comparison
Lesson learned
Q&A
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Thank-you
© 2007 NFOE et associés architectes, NXL Architects & SNC-Lavalin Pharma
www.nfoe.com
The GMP Core Lab – Expectations vs. Realities
www.nxl.ca
www.snclavalin.com
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