GMP Facilities
The GMP Core Facility
Our space consists of a 1,500 square foot facility consisting of six rooms (pictured below), labeled A through F, including class 10,000 (ISO 7) rooms (C and D) and gowning and de-gowning rooms.
The GMP Core follows a set of standard operating procedures for the use, cleaning and validation of all fixed equipment, and for the purchase, tracking and storage of supplies and for training personnel.
Access is restricted to authorized personnel only.
Room A
The gowning area with negative atmospheric pressure and at Class 100,000 (ISO 8). It contains personal protective equipment (e.g. sterile gowns, gloves, shoe covers, etc.), trashcan and disinfectants (e.g. 70% ethanol).
Room B
A vestibule area with positive atmospheric pressure. It contains a refrigerator (+2-8oC) and shelving units for equipment, reagent, and instrument storage.
Room C
A cell processing area with positive atmospheric pressure (ISO 7). It contains one biological safety cabinet, one incubator unit, one centrifuge, one microscope, and various instruments (e.g. pipette, pipet aid).
Room D
A cell processing area with positive atmospheric pressure (ISO 7). It contains one biological safety cabinet, one incubator unit, one centrifuge, one microscope, two water baths, one balance, and various instruments (e.g. pipette, pipet aid).
Room E
A vestibule area with positive atmospheric pressure. Room E contains a COBE cell separator, one freezer (-20oC), one deep freezer (-80oC), shelving unit for storage, and one Sebra tube sealer.
Room F
The gown out area with negative atmospheric pressure at Class 100,000 (ISO8). It contains trashcans for personal protective equipment disposal and gown collection.
Room 105
A GMP Core office space where operational SOPs are stored.
Open Clinical Trial and GMP Publications
Induction of alloanergy in human donor T cells without loss of pathogen or tumor immunity.
Davies JK, Yuk D, Nadler LM, Guinan EC. Transplantation. 2008 Sep 27;86(6):854-64.