GMP Facility

Cell Immunotherapy and Gene Therapy (CITGT) Good Manufacturing Practice (GMP) Facility

The Cell Immunotherapy and Gene Therapy GMP facility supports the manufacture of investigational new drug (IND) products for principal investigators under FDA rules and regulations.

The facility consists of 3,000 square feet and is located on the North Campus of Roger Williams Medical Center. The facility was established in 2001 to support the adoptive T-cell therapy program of immunotherapy and also serve as a core for the Roger Williams’ cancer center, surgical immunotherapy, gene therapy, and biotherapeutic development programs. Our specialized GMP facility is one of the eight facilities in nation that support adoptive T-cell therapy based phase I and phase II clinical trials that require gene modified T-cells or bispecific antibody conjugated T-cells.

GMP Facility: Features

Two positive pressure ISO Class 6 Clean rooms with access to an additional suite to extend capacity

Positive pressure ISO Class 7 Ante room

Meet or exceed FDA requirements for air flow

24/7 monitoring, alarm system for critical equipment

In-built sterilization capability in GMP suites and in material quarantine room

Restricted key code access to facility and GMP suites

Separate process development lab for optimization

Highly knowledgeable and trained team to support regulatory, QA, manufacturing and QC functions

Established SOPs for laboratory controls and MBR for manufacturing control and record keeping

GMP Facility: Equipments

Bio-safety Cabinets

Laminar Flow Work Station

CO2 Incubators (reach-in)#

Wave Bioreactors

Liquid Nitrogen Freezers#

4oC refrigerators#

-80oC Freezers#

-20oC Freezers#

Cell Harvester

Sterile Tube Sealer

Sterile Tube Connector

Peristaltic Pump

ELISA plate reader

Radioactivity room

Microscopes

Centrifuge

(# = Equipment on real-time monitoring and alarm system)

GMP Facility: Services and Capabilities

Develop and validate SOPs, MBR, forms etc.

Support CMC section for IND, Quality Assurance, regulatory, audits, review, Quality Control

Produce gene modified T-cell (capacity > 1011 cells/ batch)

Gene Transfer of cells with viral vectors

Bispecific antibodies production by biochemical conjugation

Biochemically conjugated-T cell (capacity > 1011 cells/ batch)

Pre and post treatment cell banking

QC test for gene expression, endotoxin, viability, cytotoxicity

For inquiries regarding clinical trials, research collaborations, and cell production, please contact:

Prajna Guha, PhD

Research Scientist/Production & Compliance Supervisor

401-456-5783

prajna.guha@chartercare.org

Anthony Bais, PhD

Research Scientist/Biologic Product Development Supervisor

401-456-6471

anthony.bais@chartercare.org