Read more \u00bb<\/a>[\/vc_column_text][vc_separator type=”transparent” thickness=”1″ up=”0″ down=”20″][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_column_text]We provide both manufacturing and regulatory support needed by clinical research investigators to navigate the challenges of Phase I\/II clinical trials. To ensure patient safety and compliance with current Good Manufacturing Practices, we operate under a comprehensive Quality Assurance program.[\/vc_column_text][vc_separator type=”transparent” thickness=”1″ up=”0″ down=”20″][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_accordion collapsible=”yes” style=”boxed_toggle”][vc_accordion_tab title=”Facilities” background_color=”#f6f6f6″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner][vc_column_text]<\/p>\nFacilities<\/h3>\n
The GCTL is a 2,200 sq.ft clean room facility located in the UW TRU. It has four separate ISO class 7 BL2 suites (with two suites under negative pressure).<\/p>\n
Each suite is equipped with biosafety cabinets, incubators, centrifuges and refrigerators. It has a CliniMACS\u00ae<\/sup>\u00a0cell selection system for cell enrichment and \/or cell depletion.<\/p>\nThe facility is also equipped with a controlled rate freezer and LN2 vapor storage system. The equipment is continuously monitored by a validated Reese Centron\u00ae<\/sup>\u00a0monitoring system.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab title=”Services” background_color=”#f6f6f6″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner][vc_column_text]<\/p>\nServices<\/h3>\n
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<\/p>\n
\n- Trained GCTL scientific staff<\/li>\n
- Training of investigator staff in cGMP<\/li>\n
- Pre-clinical studies consultation and Process development<\/li>\n
- Assistance in writing CMC section of IND<\/li>\n
- Development of SOPs<\/li>\n
- Documentation and regulatory filling support<\/li>\n
- Secure archiving of study samples<\/li>\n
- Quality Assurance oversight<\/li>\n<\/ul>\n
<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab title=”How researchers use this resource” background_color=”#f6f6f6″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner][vc_column_text]<\/p>\n
How researchers use this resource<\/h3>\n
The GCTL\u00a0 has manufactured clinical cell products for a number of diverse investigator INDs.[\/vc_column_text]
<\/p>\n
\n- A Phase I Study of HER-2\/neu Specific T Cells in Patients with Advanced Stage HER-2\/neu Expressing Cancers who Have Received a HER-2\/neu Vaccine.<\/li>\n
- Production and Testing of a new Lot of Bacteriophage PhiX174 antigen (FDA BBIND 714) for Clinical Use.<\/li>\n
- A Phase I Study to Evaluate the Safety and Feasibility of Cellular Immunotherapy Using Genetically Modified Autologous CD20-Specific T cells for Patients with Relapsed or Refractory Mantle Cell and Indolent B cell Lymphomas<\/li>\n
- A Phase I Study of Dose-Intensive Chemotherapy in Combination with Chemoprotected Autologous Stem Cells for Patients with Malignant Gliomas<\/li>\n
- Bone Marrow-Derived Stem Cells for End-Stage Ischemic Cardiomyopathy<\/li>\n<\/ul>\n
<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab title=”Fees” background_color=”#f6f6f6″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner][vc_column_text]<\/p>\n
Fees<\/h3>\n
We are a fee for service program. Investigators planning to use our services must work with the GCT Lab Manager to plan a budget for any grant proposal.<\/p>\n
Manufacturing done in a cGMP-compliant clean room facility is decidedly more labor intensive and expensive than the preclinical bench top work. Hence, developing a protocol budget with the GCTL prior to submitting grant proposal is strongly recommended.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab title=”Contact Us” background_color=”#f6f6f6″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner][vc_column_text]<\/p>\n
Contact Us<\/h3>\n
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