1382634466607 367e7a7d2a980c37c1ed945c8bdfc248

Center for Immunotherapy (CFI) Good Manufacturing Practices (GMP)

Buffalo, New York, US

The Center for Immunotherapy (CFI) Good Manufacturing Practices (GMP): Therapeutic Cell Production Facility is located on the 6th floor of the Gratwick Basic Science Building (GBSB) located on Elm & Carlton Streets. Consultation in the design, construction and operation of the RPCI CFI GMP was provided by the FDA during a Type C pre-facilities meeting.

The GMP cleanroom suite consists of a class 100,000 anteroom (gowning and storage) and class 10,000 cell processing room (manufacture of cell therapy products for Phase I and Phase II clinical trials). Additional space on the 6thfloor of GBSB is dedicated to provide office space, storage space and general secure areas equipped with filing cabinets and shelf space to provide storage capacity for records. Networked computers and printers for access to electronic databases are available. Conference rooms for staff meetings are available through joint departments,... Show more »

The Center for Immunotherapy (CFI) Good Manufacturing Practices (GMP): Therapeutic Cell Production Facility is located on the 6th floor of the Gratwick Basic Science Building (GBSB) located on Elm & Carlton Streets. Consultation in the design, construction and operation of the RPCI CFI GMP was provided by the FDA during a Type C pre-facilities meeting.

The GMP cleanroom suite consists of a class 100,000 anteroom (gowning and storage) and class 10,000 cell processing room (manufacture of cell therapy products for Phase I and Phase II clinical trials). Additional space on the 6thfloor of GBSB is dedicated to provide office space, storage space and general secure areas equipped with filing cabinets and shelf space to provide storage capacity for records. Networked computers and printers for access to electronic databases are available. Conference rooms for staff meetings are available through joint departments, including the Department of Immunology, Department of Gynecologic Oncology and Department of Laboratory Medicine.

Occupying 628 ft2,the CFI GMP Facility cleanroom suite is fully equipped to provide extensive cell processing capabilities required by different investigator-initiated studies. GMP Facility personnel are responsible for maintaining the equipment in the CFI GMP cleanroom suite as required by the FDA.

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Mammalian Cell Culture
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The GMP cleanroom suite consists of a class 100,000 anteroom (gowning and storage) and class 10,000 cell processing room (manufacture of cell therapy products for Phase I and Phase II clinical trials). Additional space on the 6thfloor of GBSB is dedicated to provide office space, storage space and general secure areas equipped... Show more »

The GMP cleanroom suite consists of a class 100,000 anteroom (gowning and storage) and class 10,000 cell processing room (manufacture of cell therapy products for Phase I and Phase II clinical trials). Additional space on the 6thfloor of GBSB is dedicated to provide office space, storage space and general secure areas equipped with filing cabinets and shelf space to provide storage capacity for records. Networked computers and printers for access to electronic databases are available.

New Cell Manufacturing Technology:
The RPCI GMP Facility has a new, one-of-a-kind, barrier isolator incubation technology that provides:
- An improved Class 100 aseptic environment, separating the manufacturing personnel from the product through a physical barrier.
- A controlled atmospheric environment, temperature and humidity allowing cellular manufacture under near physiologic conditions, enabling cells to thrive.
- Continuous real-time monitoring of potential particulate contaminants, temperature, humidity, O2, CO2 and pressure differentials for a well controlled production process.
- ClO2 sterilization technology to eliminate contamination and prevent cross-contamination of products.
This new technology will promote quality production of cellular products and enhance patient safety.

Equipment:
- BioSpherix Xvivo XvivoBarrier Isolator (n=1)
- 4 ftClass 2 Biological Safety Cabinet (n=1)
- Tabletop Centrifuge, Refrigerated (n=2)
- CO2Incubator (n=3)
- Elutra® Cell Separation Device (n=1)
- 37o Waterbath(n=1)
- Inverted Phase Contrast Microscope (n=1)
- Endosafe-PTS Endotoxin Reader (n=1)
- OhausBalance (n=2)
- Terumo Sterile Connecting Device (n=1)
- Luminometer(n=1)
- SebraTube Sealer (n=1)
- 4oC upright refrigerator (n=1)
- ACT10 Cell differential counter (n=1)
- Sanyo -80oC mechanical freezer (n=1)
- -20oC Under-the-counter freezer (n=1)
- Stanley Key Card Access System (n=1)
- IsensixARMS (n=12)
- MagnahelicGauges (n=2)

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Biology
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Cells and Tissues
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