A
R
ST.
RD .
WI
LK
INS
P Garage 1
UR
P McGovern Commons &
Trevisio
SU
D.
JOHNSON AVE.
MAP LEGEND METRORAIL
OO
ST.
M.D. Anderson Cancer Center
HWY 288
cGMP CORE UNIVERSITY OF HOUSTON
D. BLV
OD
O SW
AE
BR
HOLCOMBE BLVD. SOUTH LOOP 610
A
ACCOMODATIONS
P
PARKING
ST. NIN
at Houston Methodist is designed to provide not only the infrastructure and equipment for cGMP UN
manufacturing and release, but also the expertise
IVE
RICE UNIVERSITY RS
ITY
to guide and implement GMP manufacturing
D.
AIN
protocols for investigators.
HN
Smith Tower
HM
houstonmethodist.org/cores
AT E
A
ST.
RD .
R P Garage 1
Research Institute
WI
LK
INS
SS
EN
NB
LV D.
E.
. ST
C
Baylor College of Medicine MO
UR
P McGovern Commons &
AV E.
L UL
Mary Gibb Jones Building
ST.
ST ER LIN G
SU
ND
ST.
Texas Children’s Neurological Research Institute
BLV
D.
Texas Children’s Texas Hospital Heart St. Luke’s Institute Hospital
SON AVE.
BATES ST. HMRI Communications & External Relations | RICORE-010 | MM | DH | 250 | 04.2016
MA
Trevisio
BERTNER AVE.
houstonmethodist.org/cgmpcore
Houston, TX 77030
HG
Houston Methodist
Marriot
FA NN IN
6670 Bertner Avenue
UT
EN
EE
Scurlock Tower
UT SO
Core Director: Christopher Lincoln, PhD Office: 713.441.7316 cmlincoln@houstonmethodist.org
SO
A
Hilton Houston Plaza/ Medical Center
P
DR YD
FR
P Garage 7
Jones Tower
ST.
Rice Bioscience Research Collaborative
JO P
BLV
RO
University of Texas Health & Science
P Outpatient Center
N
Houston Methodist Research Institute
Memorial Hermann Hospital
FA N
be very costly and time consuming. The cGMP Core
cGMP Core
IDG
HM
DRYDEN/TMC METRORAIL STATION
BR
UT
R
CA M
AIN
HOUSTON METHODIST RESEARCH INSTITUTE
SO
contract manufacturing organizations, which can
ND
Texas Children’s Neurological Research Institute
BATES ST.
companies outsource GMP manufacturing to
Ben Taub General Hospital
BLV
Texas Children’s Texas Hospital Heart St. Luke’s Institute Hospital
Most academic institutions and small biotechnology
HOUSTON METHODIST RESEARCH INSTITUTE
C
Baylor College of Medicine
MO
ST.
Research Institute
E.
Mary Gibb Jones Building
M.D. Anderson Cancer Center
M.D. ANDERSON BLVD.
Houston Methodist
Marriot
LV D.
. ST
L UL
M.D. ANDERSON BLVD.
AT E
P Garage 7
Jones Tower
EN
NB
ST.
HG
MA
Scurlock Tower
NIN
UT
EN
EE
AV E.
SO UT SO
P
FR
NG
Smith Tower
MI
D.
FA N
A
Hilton Houston Plaza/ Medical Center
DR YD
HN
BLV
HM AIN
Rice Bioscience Research Collaborative
JO P
RF LE
ITY
AV E.
MA
RS
ST ER LIN G
LA
IVE
ST.
UN
RICE UNIVERSITY
SS
TA UB L
N
RO
University of Texas Health & Science
P Outpatient Center
P
Hermann Hospital
FA NN I
PARKING
BERTNER AVE.
P
Current Good Manufacturing Practice (cGMP) Core
Manufacturing The facility houses four isolated, independent production rooms, which provide versatility in the manufacturing of a variety of therapeutic drugs (mRNA, nanomaterials and nanoparticles) and devices. Additionally, it houses a dedicated room
The cGMP Core at Houston Methodist is designed to provide internal investigators and external academic or industry partners with a cGMP compliant and cost-effective route to translating novel therapeutics and
for aseptic fill/finish and packaging, prior to transfer of manufactured drugs and devices for release testing, pre-clinical and clinical use.
Quality Control
devices to the clinic. This state-of-the-art
Our on-site quality control laboratory, located on the
facility manufactures therapeutics and novel
11th floor of the Houston Methodist Research Institute,
devices for first-in-human clinical trials.
provides testing and release for manufactured
These therapeutics and devices are produced under tightly controlled and regulated conditions, critical for the translation of novel discoveries from the bench to the clinic. NANOPARTICLE PRODUCTION
products with strict adherence to FDA requirements. These tests confirm the quality, identity, purity and strength of the manufactured drugs in order to ensure that we deliver safe and effective products to our patients.
WET BENCH WAFER PROCESSING
MRNA PRODUCTION/PURIFICATION
Features • ISO 7 certified manufacturing suites to produce therapeutic drugs and devices for both preclinical toxicology studies and phase I/II clinical trials. • Continuous power (generator) for all critical equipment. • Continuous monitoring of critical parameters: temperature, differential pressure and humidity. • Validated monitoring of all equipment, including HVAC. • Provisions for nitrogen and other gases. • I n-house pH neutralization system to process wet bench waste streams. • Key-card-restricted access.