Cell Processing at CAGT. Overview. Adrian P. Gee Center for Cell & Gene Therapy. CAGT Introduction

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1 Cell Processing at CAGT Adrian P. Center for Cell & Gene Therapy CAGT Introduction Overview Facility Description Products prepared Flow cytometry Quality Control Quality Assurance 1

2 Center for Cell & Gene Therapy CAGT Component Parts Basic & Translational Research Clinical Treatment & Research 2

3 Feigin Center at TCH 15 th Floor Protocol & Regulatory Affairs 16 th Floor Offices and GMP facilities Primary Location 17 th Floor Translational Research Translational Research 17 th Floor Performs Pre GMP research and translation Performs Pre GMP research and translation ~ 80 staff, graduate students, post docs and PIs Excellent source of new GMP projects 3

4 GMP Facilities GMP History There has been a GMP facility at BCM since 1992 vector manufacturing Expanded on arrival of CAGT in 1998 Construction of GMP Cell Processing Subsequent reconstruction o of Vector Facility Moved to 16 th floor in

5 Construction 16 th Floor Feigin Center 5

6 Cell Processing Main Vector Production Facility 6

7 Special Processing Receiving & Storage 7

8 Cell Banks Quality Assurance & Control 8

9 Offices & Administration HVAC Systems Cell Processing Facility 60 air changes per hour Recirculated air 9

10 CPF Flowpath Cell Processing Facility Single corridor design HVAC Systems Vector Production Facility 60 air changes per hour 100% exhausted air 10

11 VPF Flowpath Vector Production Facility Clean & dirty corridors Quality Control Cell Processing Released Supplies Quality Assurance Quality Control Cell Storage Gowning Freezer Storage Flow Flow Cytometry Gowning Vector Production Materials Management Traffic Pattern Cell Processing Supplies Administration Pass through Offices & Administration QA Materials Management Supplies Gowning Swing Suites Vector Production QA 11

12 Range of Cell & Gene Therapy Products HPC Dendritic Cells Cytotoxic T Cells Natural Killer Cells Mesenchymal Stromal Cells Lymphoblastoid Cells Monocytes Viral Vectors Leukemia Cell Vaccines Products Manufactured Products Manufactured Hematopoietic Progenitor Cells (HPC) HPC, Marrow, Unmanipulated HPC, Marrow, Red cell-depleted HPC, Marrow, Plasma depleted HPC, Marrow, CD34 selected HPC, Apheresis, Plasma-depleted Marrow mononuclear cells (MNC) cardiac repair Marrow CD34-selected cardiac repair Marrow MNC traumatic brain injury Marrow MNC stroke patients HPC - Cord blood AC133-selected, ex vivo expanded For hearing loss & brain injury Lymphoblastoid cell lines +/- genetic modification Intermediate product Donor leukocytes (DLI) Hepatic progenitor cells Pancreatic islet cells allogeneic GMP-grade EBV NK Cells Products Manufactured Cytotoxic T cells (CTLS) CTLs EBV directed CTLs LMP2 directed CTLs LMP1/LMP2-directed CTLs Adenovirus directed CTLs tri-virus directed CTL EBV/Neuroblastoma directed CTL- Genetically modified (TGFβ etc) Genetically-modified allodepleted donor T lymphocytes Tumor vaccines +/- genetic modification TV autologous neuroblastoma-directed TV- allogeneic neuroblastoma-directed TV- autologous CLL-directed Mesenchymal stem/progenitor cells (MSC) Antigen presenting cells (APC) APC dendritic cells Intermediate product APC monocytes intermediate product APC gene modified leukemic cell lines 12

13 Flow Cytometry 4.5 Staff CAP accredited d 2BD Canto II & 1 Canto 6Lyse Wash Assistants Product analysis Mobilization Immune reconstitution Quality Control 7Staff Perform or send out all product testing Endosafe Mycoplasma Bioburden Viral titers EBV (for TCH) Recombinant virus detection Environmental monitoring 13

14 Quality Assurance 3 staff (1 TBA) Review production records Review equipment & environmental records Control documentation Training Proficiency i Competency Master Files Etc.etc. Audits GMP External Customers 14

15 Come & see the real thing! Tours available both afternoons 15