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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HOUSTON METHODIST RESEARCH INSTITUTE

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St. Luke’sHospital

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HeartInstitute

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E. CULLEN ST.

ROSS STERLING AVE.

MemorialHermannHospital

Garage1 LA

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FLEM

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VE.

Ben TaubGeneralHospital

BaylorCollege

of Medicine

Marriot

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Universityof TexasHealth &Science

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HOUSTON METHODIST RESEARCH INSTITUTE

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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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