gene therapy / cell therapy / stem cells – regulations for the "new biologics"
DESCRIPTION
TRANSCRIPT
WRT&A1
Gene Therapy / Cell Therapy / Stem Cells –
Regulations for the "New Biologics"
William R. Tolbert, Ph.D.AOAC-SCS Regulatory & Compliance
Conference
Friday March 30, 2007 – 10:50 AM
WRT&A2
Applications of FDA Authority Through Product-Centric Centers
WRT&A3
Review of Cell-Based Products
WRT&A4
Products Regulated in OCTGT
Somatic cell therapies
Tumor Vaccines Gene therapies Xenotransplantat
ion Combination
products
Devices used for cell/tissues
Unique assisted reproduction (ooplasmtransfer)
Anti-idiotype antibodies
Tissue and tissue based products
WRT&A5
Somatic cell therapiesGene therapies
Cell therapies are products composed of human or animal cells, or from physical parts of those cells.
Gene therapies introduce genetic material into the body to replace a defective or missing gene, or to treat or cure a disease medical condition.
WRT&A6
Gene Therapy
Ex Vivo
Donor/Recipient
Cell
Cell
DNA
Ex Vivo
Donor/Recipient
Cell
DNA
In Vitro Manipulation
In Vivo
Donor Recipient
Cell DNA
Virus/Vector
In Vivo
Donor Recipient
Cell DNA
Virus/Vector
In Vitro Manipulation
WRT&A7
Vectors for delivery
WRT&A8
Autologous cells transduced with vector
WRT&A9
Somatic Cell TherapyAutologous
Donor/Recipient
Cell
Cell
Cell
In Vitro Manipulation
Allogeneic
Recipient
Cell
Cell
In Vitro ManipulationCord Blood Donor
WRT&A10
Xenotransplantation
Xenotransplantation is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.
WRT&A11
Xenotransplantation – Not Feasible
Recipient
Cell
CellAnimal DonorAnimal Donor
In Vitro Manipulation
WRT&A12
The Pre-2005 Regulatory Environment for Manufacturing
21 CFR PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES [Computer Use]
21 CFR PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES [GLPs]
21 CFR PARTs 210-211—CURRENT GOOD MANUFACTURING PRACTICE [cGMPs]
21 CFR PARTs 600-680—BIOLOGICAL PRODUCTS
21 CFR PART 820—QUALITY SYSTEM REGULATION [Medical Device GMPs]
WRT&A13
How are Cell-Based Products Different?
Potential for adventitious agents in starting material - possible lack of adequate methods for testing or removal.
Requirement for “aseptic processing”
Inability to effectively “sterilize” the product and often implantation must occur before testing is complete.
WRT&A14
FDA Driving Forces & Challenges for Cell Products
Previous approach (pre 1997) fragmented inadequate inadequate
New products (e.g. stem cells, tissue-engineered, etc.)
New manufacturing technologies, degree of manipulation
Increasing public health concern Increasing demand for cells and tissues Public confidence in products - expectation for
expectation for safe & effective product Industry standards not always followed, not
enforceable
WRT&A15
Cell and Tissue Characteristics
Autologous vs. Allogeneic Viable vs. Nonviable Banked vs. Unbanked Homologous vs. Non-homologous function Minimal vs. More than minimal
manipulation Structural vs. Systemic function Combination product– device, biologic or
drug
WRT&A16
FDA Regulation of Cellularand Tissue-based Products
Human cells, tissues, or cellular or tissue-based products based products [HCT/P’s] Articles containing human cells or tissues that
are intended for transplantation, infusion or transfer into a human recipient
Not including vascularized organs, allogeneic bone marrow transplantation, transfusable blood/blood components, xenotransplantation
Provides a unified, comprehensive regulatory framework
Provides a tiered regulatory approach level of regulation proportional to the degree of
risk
WRT&A17
New FDA Regulation 21 CFR 1271: PART 1271— HUMAN CELLS,
TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Subpart A—General Provisions Subpart B—Procedures for Registration and Listing Subpart C—Donor Suitability Subpart D—Current Good Tissue Practice (cGTPs) Subpart E—Additional Requirements for
Establishments Described in § 1271.10 (PHS 361 Products)
Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 (PHS 361 Products)
Final Rule is effective May 25, 2005.
WRT&A18
21 CFR Part 1271“A Line in the Sand”
Regulated As
HCT/P’s under Section 351 of PHS Act
(Biologics or Devices -Must prove safety and
efficacy)
HCT/P’s under Section 361 of PHS Act
(Only for prevention of communicable disease –
No proof of efficacy)
· More than minimally manipulated
· Intended for Non-Homologous Use
· Systemic effect dependent upon metabolic activity (Allogeneic, except close relative)
· Clinical effect is systemic or dependent upon the metabolic activity of the cells for its primary function
· Combined with a device, drug or biologic
· Generally, HCT/P’s recovered, processed, stored, or distributed by methods not intended to change tissue function or characteristics
· Minimally manipulated, homologous use, metabolic tissue for self or close blood relative, or for reproductive use
WRT&A19
Regulatory Requirements for HCT/P’s
“A Line in the Sand”
cGMPs Biologics cGTPs
cGTPs cGTPs cGTPs
QSRs Biologics cGTPs
Tissue CellularTherapeutic
TissueEngineering(Combination of Cells and Device)
Requirements
Premarket Approval
351 PHS Act , FD&CIND, IDE, BLA, PMA
Marketing NotificationFD&C 361 PHS Act
WRT&A20
“361” HCT/Ps (Human cells, tissue and cellular and tissue based products)
Regulated solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 (or 1270)
(“Below the line products”) Traditional: bone, tendons, corneas, Newly regulated: reproductive, autologous cord
blood Part 1271 fully effective May 25, 2005, for all
HCT/Ps recovered after that date Cell based products that meet the Part 1271 limits Human heart valves and dura mater now
regulated solely under 361/1271 if not more than minimally manipulated
No market notification or approval required.
WRT&A21
21 CFR 1271.10 (“Below the line”)
HCT/P regulated solely under section 361 of PHS Act and regulations in part 1271 if it meets all of the following criteria:(1) HCT/P is minimally manipulated(2) HCT/P is intended for homologous
use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent
WRT&A22
21 CFR 1271.10 (“Below the line”)
(3) Manufacture of HCT/P does not involve the combination of the cell or tissue with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P
WRT&A23
21 CFR 1271.10 (“Below the line”)
(4) Either:(i) HCT/P does not have a systemic effect and
is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for:(a) Autologous use(b) allogeneic use in a first-degree or second-degree
blood relative, or(c )reproductive use
WRT&A24
Minimal Manipulation
(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and
(2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of the cells or tissues
Guidance for Industry and FDA Staff: Minimal Manipulation for Structural Tissue Jurisdiction Update(www.fda.gov/cber/gdlns/minimaljur.htm)
WRT&A25
Homologous Use
The repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
WRT&A26
“351” HCT/Ps (Human cells, tissue and cellular and tissue based products)
Regulated under sections 361 and 351 of the PHS Act and under the FDC Act “Above the line” – do not meet all Part
1271 definition limits for “361” products Traditional: Cell based products requiring
compliance with Parts 210, 211 and Parts 600
Subject to routine FDA inspections Requires market approval licensing
(IND/BLA)
WRT&A27
21 CFR Part 1271Establishment Registration and Listing
Requires establishments to register with FDA and list HCT/P’s Exclusions for some (e.g., storage,
carriers, contractors engaging only in recovery and transport)
Lists criteria to determine if HCT/P’s regulated solely under 361 PHS Act
WRT&A28
21 CFR Part 1271Donor Eligibility
Screening and testing of most cell and tissue donors for relevant communicable diseases Exception for autologous donor/ sexually intimate
partner Donor must be eligible prior to HCT/P
administration Free of risk factors & clinical evidence of
communicable disease Acceptable test results Limited exception to use when eligibility
determination not completed urgent medical need, w/o other comparable HCTP
available Limited use of HCT/P from an ineligible donor
WRT&A29
21 CFR Part 1271Good Tissue Practices (cGTPs)
Procedures and controls to prevent introduction, transmission and spread of communicable disease by HCT/P’s communicable disease agents – prior to and
during manufacturing Organized around core requirements, with
supporting requirements Follow all GTP requirements applicable to
function performed Requirement for a Quality Program
Flexibility to determine how to meet requirements
WRT&A30
cGTP Basics Methods, facilities, and controls for
manufacturing to prevent infectious disease contamination
Broad goals applicable to the wide range of HCT/Ps
Establishments have the flexibility to determine how to meet goals through their own procedures
Requires a quality program to prevent, detect, and correct deficiencies that could increase communicable disease risk
WRT&A31
21 CFR Part 1271
Inspection and Enforcement Applicability
Above the line (351 HCT/Ps) – Same as for other Biologics and Devices (Clinical, Pre Approval, Post Approval)
Below the line (361 HCT/Ps) – New requirements specified (Any time after registration)
Inspections May include your establishment, facilities, equipment, finished
and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and controls required to be maintained under Part 1271.
May question the personnel of the establishment as necessary to determine compliance
May take samples, may review and copy any records required to be kept under this part, and may use other appropriate means to record evidence of objectionable observations
The inspection may be made with or without prior notification The frequency of inspection will be at the agency’s discretion
WRT&A32
CBER’s Bioresearch Monitoring Branch
Conduct pre-approval data audit inspections Investigate complaints Answer questions about Good Clinical
Practices Help evaluate concerns about data integrity
Clinical investigators Sponsor/Monitor/CROs IRBs GLP/Nonclinical Labs
WRT&A33
CBER is assigning more inspections of
ongoing studies under IND/IDE
Cell therapies Gene transfer Vaccines Blood products Devices
For FY 2005, CBER inspected 50 sites enrolling pediatric subjects
WRT&A34
FY 2006 HCT/P Inspections
Type of HCT/P establishment
Number of
Inspections
Hours/ Inspecti
on
Reproductive tissues
87 45.7
Cord blood stem cells Peripheral blood stem cells
36 42.8
All other HCT/Ps 234 44.1
Total 354
WRT&A35
Human Stem Cells Stem Cell-Based Therapies – Stem
cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases including, spinal cord injury, burns, heart disease “Adult” Stem Cells – Less pluipotent,
immune rejection issues “Embryonic” Stem Cells – More pluipotent,
ethical / political issues
WRT&A36
Bone marrow stroma/Mesenchymal stem cellsFacilitate hematopoietic reconstitution
WRT&A37
WRT&A38
WRT&A39
Human Embryonic Stem Cell Lines
Issues Receiving Attention: Media used for culturing hES cells is routinely
supplemented with bovine serum (concern over BSE/TSE, vCJD) as well as other animal-derived ancillary products.
Characterization of therapies derived from hES cells as xenotransplantation products: use of irradiated murine embryonic fibroblast feeder layers.
Published technical report in Nature Medicine: Human embryonic stem cells express a nonhuman immunogenic sialic acid (Neu5Gc).
Karyotypic / genetic stability of long-term hES cell cultures
WRT&A40
WRT&A41
Human Embryonic Stem Cell Lines Human ES Cell Lines Established on Non-
Human Feeder Cell Layers Fit the definition of xenotransplantation as
defined in CBER Guidance for Industry issued April 2003.
FDA DOES NOT intend xenotransplantation requirements to preclude use of hES cell lines in human clinical trials.
For stem cell products derived from hES cell lines raised on non-human feeder layers it may be necessary to demonstrate that the hES cell line is free from infectious agents that may pose a risk for transmission to recipients. (Adventitious agent testing is equally important when feeder layers are comprised of human cells)
WRT&A42
Cell Therapy Product Characterization
Morphologic evaluation Unique biochemical markers Gene and protein expression analysis Cellular impurities profile Biologic activity/Potency Identity: HLA, other unique marker
WRT&A43
Product Safety and Efficacy
Safety Issues: Sterility (bacterial, fungal, mycoplasma) Purity Identity Segregation and tracking
Efficacy Issues: Potency Stability
WRT&A44
Cell Therapy Preclinical Assessment: Activity and Safety
Cell Fate Post Transplant Post transplant survival Cell migration Cell differentiation Cell phenotype expression Anatomic/functional integration into
host physiology Tumorigenic / proliferative potential
WRT&A45
Cell Therapy Preclinical Assessment: Animal Models
Animal Models Use of existing models (i.e., EAE model) to
“predict predict” activity & safety Incorporate activity & toxicity endpoints in an
animal model of disease Comparative anatomy & pathophysiology to humans Consider the route of administration/delivery system Immune tolerance to human cells….or use of analogous cells from animals
Understand abilities & limitations of model(s) used
WRT&A46
Cell Therapies: Characterization Issue: Key questions for safety and
effectiveness What are the critical characteristics to
measure: Genes (30,000 30,000-40,000/cell) Proteins? (40,000/cell) Secreted molecules? (5,000/cell) Microenvironment?
Can Can’t measure everything! How to identify what matters?
WRT&A47
Manufacturing Facilities
Capacity Issues Patient-Specific vs. Allogeneic Processing Time Quarantine Issues
Aseptic Processing for All Steps Labor Intensive High Level of Support Requirements Scheduling Issues
WRT&A48
Open vs. Closed Manufacturing Systems
FDA Cleared or Approved Sterile Tube Connecting Device (STCD) – Tubing Welders Developed for the Blood industry.
STCDs may be used for interconnecting sterile bag systems for cell and gene therapy applications.
WRT&A49
Example Facility
Standard Cell Therapy Unit 150 ft2, 2 Operators Capacity 25 to 100
Products / Year Clinical Facility
6 Units – 5,000 ft2 (18%) Capacity 150 – 600
Products / Year Commercial Facility
24 Units – 25,000 ft2 (15%)
Capacity 600 – 2,400 Products/Year
UnfinishedArea169
16.0' x 39.8'
Women's Toilet154 15.8'x7.2'
Men's Toilet153 15.8'x7.3'
QC Laboratory125
18.0' x 20.5' QC Micro127
13.0' x 10.0'
Media Testing126
13.0' x 10.0'
Pat
ient
/Don
or S
tora
ge
Cor
rido
r 10
0 2
5.0'
x 8
.5'
SurrogateCulture
13417.0' x 29.5'
Gown 1309.5' x 4.0'
ReadySupplies -
KitAssembly
1319.5' x 25.0'
GownDegown
1337.5' x 9.8'
ProductionSupport A 132
15.5' x 9.8'
JanitorCloset 12810.0' x 8.5'
Flow Cytometry129
18.0' x 11.5'
29.5
' x 9
.0'
Mec
h R
oom
A23
.5' x
3.5
'
11210.5' x 8.0'
100A 21.5' x 4.0'
SterilityTesting121R
10.3'x10.0'
Gown1216.0'
x 10.0'
10410.5' x 15.5'
10210.5' x 11.5'
Reception103
13.0' x 9.5'
10813.5'x7.7'
100A
56
.2' x
3.5
'
100C21.5' x 5.7'
Exit100B6.5'
x12.3'
100E 100.5' x 6.0'
2 ft. 6.0 in. x 18 ft. 6.0 in.
BZEm
PT
27.5
' x 8
.0'
Radioisotope Lab123L
15.5' x 10.0'
BlastogensisLab 150
10.5'x10.0'
1236.0'
x 10.0'
Released Materials122
23.0'x10.0'
RetainSamples
121L7.5'x10.0'
MechRm B1205.8'
x11.2'
100D12.5' x 6.2'
1119.0'x12.3'
1109.0'x12.3'
10913.5'x12.3'
10713.5'x11.8'
10613.5'x11.8'
10513.5'x7.5'
5.0'
x1.5
'4.
0'x1
.5'
6.5'
x3.0
'
10110.5' x 11.5'
1199.5' x 9.0'
11811.5' x 9.0'
Women 11615.0' x 6.0'
Men 11515.0' x 6.2'
Res
troo
m 1
1712
.7' x
6.0
'
Break / Conference114
21.5' x 12.3'
11310.5' x 8.0'
PT
Stairs7.5' x 5.0'7.5'
x9.0'
4.5'x6.0'
69.0'x5.3'
K
K
K
BZGown Corridor Rm 162 49.0' x 6.0'
Production Support B 160 52.0' x 8.0'P
rodu
ctio
n D
166
19.
0' x
8.0
'
Pro
duct
ion
E16
7 1
9.0'
x 8
.0'
Pro
duct
ion
C16
5 1
9.0'
x 8
.0'
Pro
duct
ion
B16
4 1
9.0'
x 8
.0'
R
Duc
tR
D
uct
R
Duc
t
R
Duct
Pro
duct
ion
A16
3 1
9.0'
x 8
.0'
R
Duc
t
R
Duct
R
Duc
tR
D
uct
PT PT PT
Pro
duct
ion
F16
8 1
9.0'
x 8
.0'
PT
R
Duc
tR
D
uct
R
Duc
tR
D
uct
PTPT R Duct
PT
K
PT
CellIrradiation
123R7.5'x10.0'
14.0
' x 6
.0'
Degown161
9.0'x6.0'
K
6.0'x13.0'Gown
Toilet
Sin
k ToiletUrinal
Sin
k
Women's Lockers156
15.7'x12.8'
Men's Lockers155
15.8'x12.8'
Toilet
Em
ProductRelease/Package
1589.5'x15.0'
Ship -Receive
1599.5'x13.8'
PT
PT
K
Mechanical Room C151
25.5' x 11.2'
QuarantineStorage
15217.5' x 20.5'
Patient
Receive
Donor
Receive
Clean Closet157 9.5'x4.2'
Em
Room Layout and Dimensions
Total Facility Dimensions 163.0'x80.0'
PT
PT
WRT&A50
UnfinishedArea 169
Women's ToiletMen's Toilet
153
Lab
orat
ory
Cas
ewor
k
FlowCytometer
QC Laboratory125
QC Micro127
Media Testing126
Pat
ient
/Don
or S
tora
ge
Cor
rido
r 10
0
SurrogateCulture
134
Gown 130
ReadySupplies -
KitAssembly
131
GownDegown
133
ProductionSupport A 132
JanitorCloset 128
Flow Cytometry129
Mec
h R
oom
A
112
100A
SterilityTesting121R
Gown121
104
102 Reception103
108
100A
100C
Exit100B
100E
2 ft. 6.0 in. x
18 ft. 6.0 in.
BZEm
PT
Radioisotope Lab123L
BlastogensisLab 150
123Released Materials
122
RetainSamples
121L
MechRm B120
100D
111 110 109
107
106
105
101
119 118
Women 116
Men 115
Res
troo
m 1
17
Break / Conference114
113
PT
Stairs
K
K
K
BZ
CO2
Incub
Table
Com
pute
r
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
Gown Corridor Rm 162
Production Support B 160P
rodu
ctio
n D
166
Pro
duct
ion
E16
7
Pro
duct
ion
C16
5
Pro
duct
ion
B16
4
R
Duc
tR
D
uct
R
Duc
t
R
Duct
Pro
duct
ion
A16
3R
D
uct
R
Duct
R
Duc
tR
D
uct
PT PT PT
Pro
duct
ion
F16
8
PT
R
Duc
tR
D
uct
R
Duc
tR
D
uct
PTPT R Duct
Cart
Cell Counte
r
Computer
SS Wire Shelving
Computer
6ft
Bio
safe
ty
Ovr
/Und
C
O2
Incu
bato
rR
ef
CentCent CentCent CentCent Cent
Car
t
CentCentCentCentCent
RefCell
Counter
Com
pute
r6f
tB
iosa
fety
O
vr/U
nd
CO
2 In
cuba
tor
Ref
Com
pute
r6f
tB
iosa
fety
O
vr/U
nd
CO
2 In
cuba
tor
Ref
Com
puter6ft
Biosafety O
vr/Und
CO
2 Incubator
Ref
Com
puter6ft
Biosafety O
vr/Und
CO
2 Incubator
Ref
Com
puter6ft
Biosafety O
vr/Und
CO
2 Incubator
Ref
6ftBiosafety
6ftBiosafety
Table
6ftBiosafety
6ftBiosafety
Cell Counte
r
Fre
ezer
Sta
inle
ssT
able
Com
pute
r
StainlessT
able
Dou
ble
Doo
r R
efri
gera
tor
Stainless S
teel Wire
Shelving
Cart
Flow
Cytom
eter D
ouble Door
Refrigerator
LaboratoryCasework
PT
Computer
Sin
kOvr/UndMicro
Incubator
6ftBiosafety
Computer
Microscop
e
6ftBiosafety
Ovr/Und CO2
Incubator
Microscop
e
Microscop
e
Microscop
e
Dou
ble
Doo
r R
efri
gera
tor
LaboratoryCasework
Table
Fre
ezer
Cent
LaboratoryCasework
Lab
orat
ory
Cas
ewor
k
Sink
Laboratory
Casew
ork
Sink
6ftBiosafety
Ovr/UndMicro
IncubatorComputer
Microscop
e
- 80 C FreezerRetain Samples
- 80
C F
reez
erR
etai
n S
ampl
es
IPA
Bench
MirrorSoiledGowns
Clean
Gow
ns
K
PT
CellIrradiation
123RScintillation
CounterHarvester
6ftBiosafety
Computer
Microscop
e
Computer
Microscope
Ovr/Und CO2
Incubator
Irradiator
Degown161
IPA
Mirror
SoiledGowns
K
Gown
SS
Wire
Shelving
Bench
Toilet
Sin
k ToiletUrinal
Sin
k
Tow
els
Tow
els
Women's Lockers156
Men's Lockers155
Toilet
Cle
an S
crub
s LockersLockers
Lockers
Lockers
Lockers
Lockers
Bench
BenchDir
ty
Scr
ubs
Cle
an S
crub
s LockersLockers
Lockers
Lockers
Lockers
Lockers
Bench
BenchDir
ty
Scr
ubs
Computer
Microscope
Lab
orat
ory
Cas
ewor
k
Em
ProductRelease/Package
158
Ship -Receive
159
Fre
eze
r
StainlessT
able
PT
Cab
inet
Com
puterS
tainless Table
PT
Com
puter
Cab
inet
K
Mechanical Room C151
QuarantineStorage 152D
oubl
e D
oor
Ref
rige
rato
r
Freezer
Dou
ble
Doo
r R
efri
gera
tor
Dou
ble
Doo
r R
efri
gera
tor
Shelving
Shelving
Shelving
Class100 WS
Computer
Double Door Refrigerator
Double Door Refrigerator
She
lvin
g
Freezer
Shelving
ComputerShelving
Double Door Refrigerator
Car
t
Car
t
Cart
Cart
Table
Patient
Receive
Donor
Receive
Double Door Refrigerator
Dou
ble
Doo
r R
efri
gera
tor
Dou
ble
Doo
r R
efri
gera
tor
Com
puterT
ableC
omputer
Bench
Clean
Gow
nsIPA
Mirror
Clean Closet157S
ink
Sink
Cabinet
SoiledGowns
Clean Gowns IPA
Em
Equipment Layout
CO2 CO2N2N2 N2 CO2 CO2N2
BiohazWaste
BiohazWaste
BiohazWaste
BiohazWaste
RadioWaste
RadioWaste
RadioWaste
BiohazWaste
CO2 CO2
PT
CO2
Incub
CO2
Incub
CO2
Incub
PT
Cen
tC
ent
Cen
tC
ent
Com
pute
r
WRT&A51
ReceivingRm 114
18.5' x 10.0'
Media TestingRm 159A10.0' x 9.0'
EnvironmentalMonitoringRm 159B
12.0' x 9.0'
Clean C
orridor BR
m 104 11.5' x 6.0'
Clean C
orridor B R
m 104 46.0' x 6.0'
Administration CubiclesRm 190
14.0' x 20.5'
QA ManagerOffice
Rm 17411.0' x 8.0'
Women's ToiletRm 187
12.0' x 11.7'Toilet Toilet Toilet
Men's ToiletRm 186
12.0' x 11.7'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Gown / DegownRm 170
10.0' x 8.0'
SterilityTesting A Rm 172
10.0' x 23.0'
SterilityTesting B Rm 173
10.0' x 23.0'
Access C
orridor C R
m 102 101.0' x 6.0'
QC Lab 3Flow Cytometer
Rm 16812.0' x 30.0'
QC Lab 1Flow Cytometer
Rm 16212.0' x 30.0'
Patient CellIrradiation
Rm 1579.0' x 9.0'
Clean C
orridor BR
m 104 23.0' x 6.0'
Clean C
orridor B R
m 104 50.0' x 6.0'
Clean C
orridor BR
m 104 12.5' x 6.0'
Personnel Entry Rm 12018.5' x 8.5'
Acc
ess
Cor
rido
r A
Rm
100
59.
5' x
6.0
'
Acc
ess
Cor
rido
r A
Rm
100
57.
5' x
6.0
'
Cle
an C
orri
dor
A R
m 1
03 3
1.0'
x 6
.0'
Cle
an C
orri
dor
A R
m 1
03 3
7.0'
x 6
.0'
Cle
an C
orri
dor
A R
m 1
03 4
4.0'
x 6
.0'
Gown Corridor B Rm 107 52.0' x 6.0'
Pro
duct
ion
4R
m 1
29 1
9.0'
x 8
.0'
Pro
duct
ion
5R
m 1
30 1
9.0'
x 8
.0'
Pro
duct
ion
3R
m 1
28 1
9.0'
x 8
.0'
Pro
duct
ion
2R
m 1
27 1
9.0'
x 8
.0'
Production Support A 133 52.0' x 11.0'
Gown Corridor A Rm 106 49.0' x 6.0'
R D
uct
R D
uct
R D
uct
R D
uct
Degown ARm 132
6.0' x 9.0'
Pro
duct
ion
1R
m 1
26 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PT PT PT
Pro
duct
ion
6R
m 1
31 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PTPTPT
Pro
duct
ion
10R
m 1
37 1
9.0'
x 8
.0'
Pro
duct
ion
11R
m 1
38 1
9.0'
x 8
.0'
Pro
duct
ion
9R
m 1
36 1
9.0'
x 8
.0'
Pro
duct
ion
8R
m 1
35 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
DegownB
Rm 1476.0'
x 10.0'
Pro
duct
ion
7R
m 1
34 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PT PT PT
Pro
duct
ion
12R
m 1
39 1
9.0'
x 8
.0'
PT
R D
uct
R D
uct
R D
uct
R D
uct
PTPT R Duct
R Duct
Pro
duct
ion
16R
m 1
44 1
9.0'
x 8
.0'
Pro
duct
ion
17R
m 1
45 1
9.0'
x 8
.0'
Pro
duct
ion
15R
m 1
43 1
9.0'
x 8
.0'
Pro
duct
ion
14R
m 1
42 1
9.0'
x 8
.0'
Production Support B 148 52.0' x 11.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
13R
m 1
41 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
18R
m 1
46 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
22R
m 1
53 1
9.0'
x 8
.0'
Pro
duct
ion
23R
m 1
54 1
9.0'
x 8
.0'
Pro
duct
ion
21R
m 1
52 1
9.0'
x 8
.0'
Pro
duct
ion
20R
m 1
51 1
9.0'
x 8
.0'
Gown Corridor C Rm 108 49.0' x 6.0'
R D
uct
R D
uct
R D
uct
R D
uct
Degown CRm 156
9.0' x 6.0'
Pro
duct
ion
19R
m 1
50 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
24R
m 1
55 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
R Duct
R Duct
Access Corridor B Rm 101 135.5' x 6.0'
Clean Corridor C Rm 105 78.0' x 6.0'
GownC
Rm 1496.0'
x 12.5'
GownB
Rm 1406.0'
x 12.5'
GownA
Rm 1256.0'
x 12.0'
Women's ToiletRm 117
11.5' x 12.5'ToiletToilet Toilet
Men's ToiletRm 115
11.5' x 12.5'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Women's LockerRm 119
18.5' x 24.0'
Men's LockerRm 113
18.5' x 24.0'C
lean
Cor
rido
r A
Rm
103
19.
0' x
6.0
'
Product ReleasePackagingRm 124
18.5' x 15.0'
CleanCloset
Rm 1225.8' x 10.0'
Janitor'sCloset
Rm 1215.8' x 10.0'
Ready Supplies AKit Assembly
Rm 110 18.5' x 20.0'Release Supplies Rm 109 18.5' x 25.5'
Quarantine Supplies Rm 111 18.5' x 18.5'
Truck DockRm 116
18.5' x 20.0'
ShippingRm 118
18.5' x 10.0'
Mechanical AreaRm 123
18.5' x 24.5'
Cold Room112
9.0' x 14.0'
Car
tP
ass
Th
ru
Car
tP
ass
Th
ru
Women's ToiletRm 165
12.5' x 11.7'ToiletToilet Toilet
Men's ToiletRm 164
12.5' x 11.7'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Surrogate Culture 1Rm 161 19.5' x 12.0'
PT
Surrogate Culture 2Rm 163 19.5' x 12.0'
Surrogate Culture 3Rm 167 19.5' x 12.0'
PT
Surrogate Culture 4Rm 169 19.5' x 12.0'
PT
QC Lab 2Blastogenesis
Rm 16612.0' x 12.0'
QC MicrobiologyRm 160
25.5' x 11.5'
Radio Isotope LabRm 171
21.5' x 8.0'
K
K
K
K
K
K
K
K
K
K
K
QA DocumentVault
Rm 17511.0' x 14.5'
PurchasingManagerOffice
Rm 19711.0' x 8.0'
QA / RA / Purchasing CubiclesRm 196
27.0' x 31.5'
Medical DirectorOffice
Rm 20111.0' x 9.0'
QA ManagerOffice
Rm 19811.0' x 8.0'
Copy / FaxRm 199
11.0' x 5.0'
Production / QC / EngineeringCubiclesRm 179
29.0' x 26.0'
FacilitiesDirectorOffice
Rm 1809.0' x 10.0'
Production DirectorOffice
Rm 17814.5' x 8.5'
Copy / FaxRm 181
9.0' x 5.0'
ProductionMangersOffice
Rm 17611.5' x 8.5'
ProductionMangersOffice
Rm 17711.5' x 8.5'
QC DirectorOffice
Rm 1829.0' x 10.0'
Training / ConferenceRm 193
20.5' x 15.5'
BreakroomRm 183
22.5' x 19.5'
HR ManagerOffice
Rm 19511.0' x 8.0'
HR AssistantOffice
Rm 19411.0' x 7.0'
IMS ManagerOffice
Rm 1849.0' x 10.0'
ComputerCenter
Rm 1859.0' x 9.0'
Plant ManagerOffice
Rm 19211.0' x 12.0'
ExecutiveAssistantOfficeRm 19111.0' x 8.0'
ReceptionRm 188
19.0' x 8.5'
Janitor's ClosetRm 189
12.5' x 6.0'
QA DirectorOffice
Rm 20011.0' x 9.0'
6.0'
x 9
.0'
6.0'
x 1
6.0'
K
K
K
E
K
6.0'
x 1
9.5'
K
K
Facility Room Layout - Total Dimensions 188.5' x 134.0'E
E
E E
R D
uct
R D
uct
PT PT PT PT PT PT
PT PT PT PT PT PT
PT
CartPassThru
RetainSamplesRm 158
6.0' x12.0'
Access Corridor A Rm 100 31.0' x 6.0'
K
PT
WRT&A52
ReceivingRm 114
18.5' x 10.0'
Media TestingRm 159A10.0' x 9.0'
EnvironmentalMonitoringRm 159B12.0' x 9.0'
Clean C
orridor BR
m 104 11.5' x 6.0'
Clean C
orridor B R
m 104 46.0' x 6.0'C
omputer
Com
puterCom
pute
rCom
puterCom
pute
r
Com
puterCom
pute
rCom
puterCom
pute
rCom
puterCom
pute
r
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
StainlessTable
Flo
wC
ytom
eter
Administration CubiclesRm 190
14.0' x 20.5'
QA ManagerOffice
Rm 17411.0' x 8.0'
Women's ToiletRm 187
12.0' x 11.7'Toilet Toilet Toilet
Men's ToiletRm 186
12.0' x 11.7'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Gown / DegownRm 170
10.0' x 8.0'
SterilityTesting A Rm 172
10.0' x 23.0'
SterilityTesting B Rm 173
10.0' x 23.0'
Access C
orridor C R
m 102 101.0' x 6.0'
QC Lab 3Flow Cytometer
Rm 16812.0' x 30.0'
QC Lab 1Flow Cytometer
Rm 16212.0' x 30.0'
Patient CellIrradiation
Rm 1579.0' x 9.0'
Clean C
orridor BR
m 104 23.0' x 6.0'
Clean C
orridor B R
m 104 50.0' x 6.0'
Clean C
orridor BR
m 104 12.5' x 6.0'
Personnel Entry Rm 12018.5' x 8.5'
Acc
ess
Cor
rido
r A
Rm
100
59.
5' x
6.0
'
Acc
ess
Cor
rido
r A
Rm
100
57.
5' x
6.0
'
Cle
an C
orri
dor
A R
m 1
03 3
1.0'
x 6
.0'
Cle
an C
orri
dor
A R
m 1
03 3
7.0'
x 6
.0'
Cle
an C
orri
dor
A R
m 1
03 4
4.0'
x 6
.0'
Gown Corridor B Rm 107 52.0' x 6.0'
Pro
duct
ion
4R
m 1
29 1
9.0'
x 8
.0'
Pro
duct
ion
5R
m 1
30 1
9.0'
x 8
.0'
Pro
duct
ion
3R
m 1
28 1
9.0'
x 8
.0'
Pro
duct
ion
2R
m 1
27 1
9.0'
x 8
.0'
Production Support A 133 52.0' x 11.0'
Gown Corridor A Rm 106 49.0' x 6.0'
R D
uct
R D
uct
R D
uct
R D
uct
Degown ARm 132
6.0' x 9.0'
Pro
duct
ion
1R
m 1
26 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PT PT PT
Pro
duct
ion
6R
m 1
31 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PTPTPT
Pro
duct
ion
10R
m 1
37 1
9.0'
x 8
.0'
Pro
duct
ion
11R
m 1
38 1
9.0'
x 8
.0'
Pro
duct
ion
9R
m 1
36 1
9.0'
x 8
.0'
Pro
duct
ion
8R
m 1
35 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
DegownB
Rm 1476.0'
x 10.0'
Pro
duct
ion
7R
m 1
34 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
PT PT PT
Pro
duct
ion
12R
m 1
39 1
9.0'
x 8
.0'
PT
R D
uct
R D
uct
R D
uct
R D
uct
PTPT R Duct
R Duct
Pro
duct
ion
16R
m 1
44 1
9.0'
x 8
.0'
Pro
duct
ion
17R
m 1
45 1
9.0'
x 8
.0'
Pro
duct
ion
15R
m 1
43 1
9.0'
x 8
.0'
Pro
duct
ion
14R
m 1
42 1
9.0'
x 8
.0'
Production Support B 148 52.0' x 11.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
13R
m 1
41 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
18R
m 1
46 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
22R
m 1
53 1
9.0'
x 8
.0'
Pro
duct
ion
23R
m 1
54 1
9.0'
x 8
.0'
Pro
duct
ion
21R
m 1
52 1
9.0'
x 8
.0'
Pro
duct
ion
20R
m 1
51 1
9.0'
x 8
.0'
Gown Corridor C Rm 108 49.0' x 6.0'
R D
uct
R D
uct
R D
uct
R D
uct
Degown CRm 156
9.0' x 6.0'
Pro
duct
ion
19R
m 1
50 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
Pro
duct
ion
24R
m 1
55 1
9.0'
x 8
.0'
R D
uct
R D
uct
R D
uct
R D
uct
R Duct
R Duct
Access Corridor B Rm 101 135.5' x 6.0'
Clean Corridor C Rm 105 78.0' x 6.0'
GownC
Rm 1496.0'
x 12.5'
GownB
Rm 1406.0'
x 12.5'
GownA
Rm 1256.0'
x 12.0'
Women's ToiletRm 117
11.5' x 12.5'ToiletToilet Toilet
Men's ToiletRm 115
11.5' x 12.5'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Women's LockerRm 119
18.5' x 24.0'
Men's LockerRm 113
18.5' x 24.0'
Cle
an C
orri
dor
AR
m 1
03 1
9.0'
x 6
.0'
Product ReleasePackagingRm 124
18.5' x 15.0'
CleanCloset
Rm 1225.8' x 10.0'
Janitor'sCloset
Rm 1215.8' x 10.0'
Ready Supplies AKit Assembly
Rm 110 18.5' x 20.0'Release Supplies Rm 109 18.5' x 25.5'
Quarantine Supplies Rm 111 18.5' x 18.5'
Truck DockRm 116
18.5' x 20.0'
ShippingRm 118
18.5' x 10.0'
Mechanical AreaRm 123
18.5' x 24.5'
Cold Room112
9.0' x 14.0'
Car
tP
ass
Th
ru
Car
tP
ass
Th
ru
Women's ToiletRm 165
12.5' x 11.7'ToiletToilet Toilet
Men's ToiletRm 164
12.5' x 11.7'
Sink
ToiletUrinal Urinal
Sink
SinkSink
Surrogate Culture 1Rm 161 19.5' x 12.0'
PT
Surrogate Culture 2Rm 163 19.5' x 12.0'
Surrogate Culture 3Rm 167 19.5' x 12.0'
PT
Surrogate Culture 4Rm 169 19.5' x 12.0'
PT
QC Lab 2Blastogenesis
Rm 16612.0' x 12.0'
QC MicrobiologyRm 160
25.5' x 11.5'
Radio Isotope LabRm 171
21.5' x 8.0'
K
K
K
K
K
K
K
K
K
K
K
QA DocumentVault
Rm 17511.0' x 14.5'
PurchasingManagerOffice
Rm 19711.0' x 8.0'
QA / RA / Purchasing CubiclesRm 196
27.0' x 31.5'
Medical DirectorOffice
Rm 20111.0' x 9.0'
QA ManagerOffice
Rm 19811.0' x 8.0'
Copy / FaxRm 199
11.0' x 5.0'
Production / QC / EngineeringCubiclesRm 179
29.0' x 26.0'
FacilitiesDirectorOffice
Rm 1809.0' x 10.0'
Production DirectorOffice
Rm 17814.5' x 8.5'
Copy / FaxRm 181
9.0' x 5.0'
ProductionMangersOffice
Rm 17611.5' x 8.5'
ProductionMangersOffice
Rm 17711.5' x 8.5'
QC DirectorOffice
Rm 1829.0' x 10.0'
Training / ConferenceRm 193
20.5' x 15.5'
BreakroomRm 183
22.5' x 19.5'
HR ManagerOffice
Rm 19511.0' x 8.0'
HR AssistantOffice
Rm 19411.0' x 7.0'
IMS ManagerOffice
Rm 1849.0' x 10.0'
ComputerCenter
Rm 1859.0' x 9.0'
Plant ManagerOffice
Rm 19211.0' x 12.0'
ExecutiveAssistantOfficeRm 19111.0' x 8.0'
ReceptionRm 188
19.0' x 8.5'
Janitor's ClosetRm 189
12.5' x 6.0'
QA DirectorOffice
Rm 20011.0' x 9.0'
6.0'
x 9
.0'
6.0'
x 1
6.0'
K
K
K
E
K
6.0'
x 1
9.5'
K
K
Facility Equipment Layout - Total Dimensions 188.5' x 134.0'E
E
E E
Towels
Towels
LaboratoryCasework
Flow
Cytom
eter L
aboratoryC
asework
Flow
Cytom
eter
LaboratoryCasework
Flo
wC
ytom
eter
S
ink
Double D
oor R
efrigerator
LaboratoryCasework
SS Wire Shelving
Computer
SS Wire Shelving
IPAWash
SoiledGowns
6ft
Bio
safe
ty
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent
R D
uct
Cart
Cent
6ft
Bio
safe
ty
Cent
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent
6ft
Bio
safe
ty
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent Cent
6ftB
iosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
CentCent
6ft
Bio
safe
ty
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent Cent
6ftB
iosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
Cent Cent
Cell Counter
Computer
SS Wire Shelving
Computer
IPAWash
SoiledGowns
6ft
Bio
safe
ty
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
CentCent
6ftB
iosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
CentCent
6ft
Bio
safe
ty
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
CentCent
6ft
Bio
safe
ty
Cent
Ovr/U
ndC
O2
Incubator
Refrig
erator
Car
t
Cent
Com
pute
r6f
tB
iosa
fety
Cent
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent
6ftB
iosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
CentCent
Cell Counter
Cell Counter
Cell Counter
SS Wire Shelving
SS Wire Shelving
Computer
SS Wire Shelving
Com
pute
r6f
tB
iosa
fety
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
StainlessTable Cent
R D
uct
Cart
Cent
Com
puter
StainlessTable
6ft
Bio
safe
ty
Cent
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent
Com
pute
r6f
tB
iosa
fety
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
StainlessTableCent Cent
Com
puter6ft
Biosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
StainlessTable CentCent
Com
pute
r6f
tB
iosa
fety
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
StainlessTableCent Cent
Com
puter6ft
Biosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
StainlessTableCent Cent
Cell Counter
Computer
SS Wire Shelving
Computer
Com
pute
r6f
tB
iosa
fety
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
StainlessTable CentCent
Com
puter6ft
Biosafety
Ovr/U
ndC
O2
Incubator
Refrig
erator
StainlessTable CentCent
Com
pute
r6f
tB
iosa
fety
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
StainlessTable CentCent
Com
puter
StainlessTable
6ft
Bio
safe
ty
Cent
Ovr/U
ndC
O2
Incubator
Refrig
erator
Car
t
Cent
Com
pute
r
StainlessTable
6ft
Bio
safe
ty
Cent
Ovr
/Und
CO
2In
cuba
tor
Ref
rig
erat
or
Cent
Com
puter6ft
Biosafety
Ovr/U
ndC
O2
Incubator
Refrig
eratorStainless
Table CentCent
Cell Counter
Cell Counter
Cell Counter
SS Wire Shelving
Bench
Mirror
IPAW
ash
Wir
e
She
lvin
g Bench
Mirror
IPA
Was
h
Wir
e
She
lvin
g
Bench
Mirror
Towels
Towels
IPAW
ash
Wir
e
She
lvin
g
Stainless Steel Wire Shelving
Sta
inle
ssT
able
Double Door Refrigerator
Fre
ezer Cart
Cart
Loc
kers
Clean Scrubs
Lockers
Bench
Lockers
Ben
ch
Bench
Storage
Cabinet
Sink Sink
Sto
rage
Cab
inet
Com
pute
r
Computer
Computer
Com
puter
Shelving
ShelvingTab
le
Ste
el S
helv
ing S
teel Shelving
Shelving
Shelving
Freezer
Com
puterF
reezer
Pack
age
Was
teT
able
Cart
Cart
Car
tC
art
Sta
inle
ssT
able
StorageCabinet
Storage Cabinet
StainlessTable
Shelving
Car
t
Microscope
Microscope
Microscope
Microscope
Microscope
Microscope
Microscope
Microscope
Double Door Refrigerator
Fre
ezer
Stainless Steel Wire Shelving
StainlessTable
Sta
inle
ssT
able
Com
pute
rCart
Coat Storage
CellIrradia
tor
Towels
Towels
6ftBiosafety
Ovr/UndCO2
Incubator6ft
Biosafety
6ftBiosafety
Ovr/UndCO2
Incubator
6ftBiosafety
6ftBiosafety
Ovr/UndCO2
Incubator6ft
Biosafety
6ftBiosafety
Ovr/UndCO2
Incubator
6ftBiosafety
6ftBiosafety
Ovr/UndCO2
Incubator6ft
Biosafety
6ftBiosafety
Ovr/UndCO2
Incubator
6ftBiosafety
6ftBiosafety
Ovr/UndCO2
Incubator6ft
Biosafety
6ftBiosafety
Ovr/UndCO2
Incubator
6ftBiosafety
Flow
Cytom
eter L
aboratoryC
asework
Flow
Cytom
eter
LaboratoryCasework
Flo
wC
ytom
eter
F
low
Cyt
omet
er
Sin
k
Double D
oor R
efrigerator
LaboratoryCasework
LaboratoryCasework
Mic
rosc
ope
Mic
rosc
ope
Com
pute
r
Computer
Computer
6ftBiosafety
6ftBiosafety
Ovr/UndCO2
Incubator
Ovr/UndMirco
Incubator
Microscope
Microscope
Computer
Microscope
6ftB
iosafety
6ftBiosafety
Ovr/U
ndM
ircoIncubator
IPAWash
Bench
Mirror
Micro
scope
Wir
e S
helv
ing
Wire Shelving
6ftBiosafety
Ovr/UndCO2
Incubator
ScintillationCounter
Harvester
Microscope
Refrigerator
Refrigerator
- 80 C F
reezerR
etain Sam
ples
Ref
rige
rato
r
Freezer
LaboratoryCasework
Laboratory
Casew
ork
Class 100
Sampling
StorageCabinet
Sin
k
PT PT PT PT PT PT
PT PT PT PT PT PT
PT
Loc
kers
Clean Scrubs
Lockers
Bench
Lockers
Ben
ch
Bench
IPAWash
SoiledGowns
Computer
Computer
Computer
Computer
Computer
Computer
Computer
Computer
CartPassThru
RetainSamplesRm 158
6.0' x12.0'
Ovr
/Und
Mir
coIn
cuba
tor
Microscope
Com
pute
r
6ftB
iosafety
6ftBiosafety
Ovr/U
ndM
ircoIncubator
Micro
scope
Wir
e S
helv
ing
Ovr/U
ndM
ircoIncubator
Microscope
Com
pute
r
SoiledGowns
Computer
- 80 C FreezerRetain Samples
- 80 C F
reezerR
etain Sam
ples
Computer
Microscope
Computer
LaboratoryCasework
Stainless Table
SoiledScrubs
SoiledScrubs
Access Corridor A Rm 100 31.0' x 6.0'
K
SoiledScrubs
SoiledScrubs
LockersLockers
Lockers Lockers
PT
WRT&A53
WRT&A54
Paradigm for Delivery of Patient-Specific Products
Massive Single Plant Problems with In-coming Patient Cells/Tissue Problems with Product Distribution No Real Economy of Scale
Production Units in Major Hospitals Optimum for Patient-Specific Transportation Issues Problems with Quality Oversight and Technical
Expertise; Facility Issues Multiple Regionally Located Plants
Concentrate Expertise and Quality Oversight Feasible Receiving and Shipping of Cells/Products
WRT&A55
WR Tolbert & AssociatesConsultants to the
Biopharmaceutical Industry
11483 Cypress Woods DriveSan Diego, CA 92131-3535
858-693-8163
[email protected] / www.wrtolbert.com