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HOUSTON METHODISTRESEARCH INSTITUTE
cGMP Manufacturing Core
Core Director: Glenn Winnier, PhDOffice: 713.441.2049gewinnier@houstonmethodist.org
houstonmethodist.org/cgmpmanufacturing
Houston Methodist Research Institute
6670 Bertner Avenue
Houston, TX 77030
houstonmethodist.org/research
HMRI Communications & External Relations | RICORE-010 | MM | DH | 500 | 08.2014
The cGMP Facility is available to Houston Methodist,
affiliated partner institutions, and collaborators to
produce novel therapies for a range of diseases.
The facility supports moving basic preclinical
discoveries into the clinical phase of development
with technology to manufacture a wide range of
molecular, nanotech, and cellular therapies.
cGMP MANUFACTURINGCORE
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Texas Children’sHospital Texas
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MemorialHermannHospital
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BaylorCollege
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Universityof TexasHealth &Science
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HOUSTON METHODIST RESEARCH INSTITUTE
ACCOMODATIONS
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A
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Houston Methodist
SOUTH
MAIN
ST.
CAMBRIDGE ST.
M.D
. AN
DER
SON
BLV
D.
MOURSUND ST.
M.D. AndersonCancer Center
BERT
NER
AVE
.
BATES ST.
JOH
NSO
N A
VE.
McGovernCommons & Trevisio
UNIVERSITY BLVD.
DRYDEN RD.
JOHN FREEMAN BLVD.
St. Luke’sHospital
Texas Children’sHospital Texas
HeartInstitute
WILKINS ST.
E. CULLEN ST.
ROSS STERLING AVE.
MemorialHermannHospital
Garage1 LA
MAR
FLEM
ING A
VE.
Ben TaubGeneralHospital
BaylorCollege
of Medicine
Marriot
Garage7
Universityof TexasHealth &Science
HWY 288
HOLCOMBE BLVD.
BRAESWOOD BLVD.
SOUTHLOOP610
TAUB
LOOP
P
P
P
P
JonesTower
OutpatientCenter
P
P
FANNIN
ST.
FANNIN
ST.
RICEUNIVERSITY
SOUTH
MAIN
ST.
SOUTHGATE BLVD.
UNIVERSITYOF HOUSTON
N
R
SmithTower
ScurlockTower
MaryGibb Jones
Building
RiceBioscienceResearch
Collaborative
Texas Children’s Neurological
Research Institute
HiltonHoustonPlaza/
MedicalCenterA
A
METRORAIL
DRYDEN/TMC METRORAIL STATION
P PARKING
MAP LEGEND
HOUSTON METHODIST RESEARCH INSTITUTE
ACCOMODATIONS
R
A
ResearchInstitute
Houston Methodist
The Houston Methodist Research Institute cGMP facility was created in 2011 to be a flexible foundry, offering industrial trial and cleanroom space. The facility is designed with architectural features and finishes in accordance with the US Food and Drug Administration (FDA) guidances and regulations, as well as international requirements for controlled cleanroom manufacturing environments, and aseptic processing.
Special Features
• Exposed surfaces and floors designed to withstand rigorous cleaning and sanitation standards which ensures product purity and patient safety.
• The HEPA filter and air-handling units that provide particulate-free air at a positive air pressure. The air quality meets class 10,000 (ISO class 7) standards.
• Continuous monitoring of critical parameters like temperature, pressure, and humidity.
• In-house high capacity ultra-pure water system and environmental monitoring to assure microbiological control.
• In-house waste treatment system to neutralize wet bench waste streams.
• All manufacturing equipment and utilities validated to meet biopharmaceutical standards (IQ/OQ/PQ). Standard operating procedures followed to ensure that all systems are functional and properly maintained.
• Controlled access facility with designated gowning areas, preparatory labs, shipping and receiving stations, storage areas, in addition to the clean rooms.
• Robust sample identification and traceability systems as well as electronic document control systems used as part of a centralized quality infrastructure.
Available Equipment
• Wet bench
• RIE-1700 Plasma Etcher
• Wafer spin rinse dryers
• Biological safety cabinets (class 1,000)
• CO2 incubators
• Tissue Culture hoods
• Room temperature and cold storage (4 °C, - 20 °C and - 80 °C)
• Auxiliary equipment including centrifuges and microscopes
• Stainless steel work surfaces
cGMP Manufacturing Core
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