Devices and Manufacturing Equipment Used for Production of Immune Cell Therapy and Cell Expansion: Scientific/User Issues
|
|
|
- Conrad Snow
- 5 years ago
- Views:
Transcription
1 Devices and Manufacturing Equipment Used for Production of Immune Cell Therapy and Cell Expansion: Scientific/User Issues Bruce Levine, Ph.D. Department of Pathology and Laboratory Medicine University of Pennsylvania
2 Activated T Cell Therapy for Infection or Malignancy Cell Processing 6. Quality Control Reinfuse cells 1. Obtain cells from patient and enrich or isolate particular cells of interest Bead 5. Remove beads and wash cells 2. Stimulate cells to grow 4. Large scale cell expansion 3. Insert potentially therapeutic genes into cells
3 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with anti- CD3/anti-CD28 Dynal Beads, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
4 Patients enrolling in clinical trials or their donors undergo leukapheresis at the Hospital Blood Bank.
5 Particular populations of cells can be enriched or isolated in the laboratory.
6 Gambro Elutra
7 Increasing rate of Buffer Flow
8 Gambro Elutra for Monocyte Isolation
9 Gambro Elutra Procedure modified for optimal lymphocyte collection based on company experience with settings for optimal monocyte collection Company provided: multi-day technical training Feedback on data collected during validation runs Letter of cross-reference to DMF
10 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with anti- CD3/anti-CD28 Dynal Beads, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
11 T Cell Activation with Antibody Coated Beads J Immunol 1997; 159: 5921 Science 1997; 276: 273 Immunol.. Rev. 1997; 160: 43 Mol. Ther. 2004; 9; 9; 902
12 Polyclonal Replicative Potential of Adult CD4 T Cells In Vitro Total Cells 1E+20 1E+19 1E+18 1E+17 1E+16 1E+15 1E+14 1E+13 1E+12 1E+11 1E+10 1E+09 1E+08 1E+07 1E+06 IL-2 Added Day 49 No IL-2 Day 50 Exponential growth (days) Mean log10 growth (fold) 9-12 Mean Pop Doubling Day Nc xls
13 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with cell-based aapc s, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
14 Off-the-Shelf Dendritic Cell Substitute: reagent for the in vitro expansion of T lymphocytes
15 Polyclonal T Cell Stimulation with LV-aAPC 10,000 RADS CD28 28 TCR CD8 CD64 CD3 Polyclonal stimulation CD8 CD8 CD8 CD8 CD8 CD8 Polyclonal Stimulation LV LV library: library: costim costim molecules molecules cytokines cytokines 3 CD64 LV-aAPC (KT64)
16 Next Generation: Cell-Based Artificial APC LV-aAPC T Cell 2 microns Suhoski et al. Molecular Therapy 15:981-8, 2007
17 Baxter Lifecell Flasks- gas permeable bags
18 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with anti- CD3/anti-CD28 Dynal Beads, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
19 WAVE Biotech Bioreactor
20 WAVE Feed and Harvest via Perfusion
21
22 Small (0.1 to 5 liter) Wave Bioreactor SYSTEM 2/10
23 Wave 2/10 perfusion w/pinch valves
24
25 WAVE Parameters Day of seeding after transduction and vector wash Cell concentration Rock rate, rock angle Media perfusion rate Media formulation (ARV, foaming, IL-2, supplements Nutrient usage, metabolite production
26 Small Scale Flask vs WAVE Population Doubling Level Small Scale WAVE PDL Days of Culture
27 Lifecell Static vs WAVE Population Doubling Level PDL C1-Wave C2-Lifecell Day of Culture
28 WAVE Bioreactor Company provided: some technical training Protocols, manuals, references available on website Letter of cross-reference to DMF References directly applicable to CD3/CD28 stimulated T cells Hami LS, Green C, Leshinsky N, Markham E, Miller K, Craig S: GMP production and testing of Xcellerated T Cells for the treatment of patients with CLL. Cytotherapy (2004); 6(6): Hami L, et.al. Comparison of a Static Process and a Bioreactor-based Process for the GMP Manufacture of Autologous Xcellerated T Cells for Clinical Trials. BioProcessing (2003); 2(6):1-10.
29 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with anti- CD3/anti-CD28 Dynal Beads, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
30 Baxter MaxSep The magnetic beads used to grow the T cells must be removed prior to reinfusing the cells to the patient. The cell culture is passed Baxter MaxSep magnets where the beads are retained and the cells flow through.
31 Activated T Cell Processing Flow Day 0 Leukocyte Apheresis Gambro Elutra depletion of monocytes Day ~10 Remove Beads (Baxter Maxsep) Day 3 to 5 Seed WAVE Bioreactor Stimulation with anti- CD3/anti-CD28 Dynal Beads, seed Baxter gas permeable culture bag Harvester (Baxter Fenwal) QC Testing QA Review Final Activated T Cell Product
32 Fenwal (former subsidiary of Baxter) Harvester Built on apheresis machine CS3000 frame. Concentrates and washes cells at up to 700mls per minute continuous flow, we run at mls per minute to increase cell yield. cells per minute depends on starting concentration. If static 1E+06/ml = 3-7E+09 cells/minute, not including washes. If 10E+06/ml = 3-7E+09 cells/minute, not including washes. closed system disposable set. Cells concentrated in belt chamber, end volume ~250mls
33 Fenwal Harvester Reservoir set, Manifold set, and Harvester set
34 The volume of the cell culture can be as much as 10 liters (2.5 gallons) or more depending on cell dose. The cells are washed out of culture media, concentrated and resuspended into 250mls (8 oz) infusible solution.
35 Fenwal Harvester Company initially provided: some technical training Repair/PM service Manual Current status No longer manufactured (~10 years) No technical, scientific, regulatory support Kits no longer manufactured (mid-2008?) Absence of comparable devices
36 Autotransfusion devices as an alternative? Different requirements for 351 vs 361? Following validation, submit data in IND annual report or ammendment?
GE Healthcare Cell Therapy Steve Hawthorn September 1st 2011
GE Healthcare Cell Therapy Steve Hawthorn September 1st 2011 In 2007 GE Healthcare Acquired WAVE Biotech Mainly large scale bioprocess and process development applications For cell therapy the cell identity,
True Confessions: Ancillary Materials in a Cell Processing Lab. Cell Processing Section, DTM, CC, NIH David Stroncek, MD Chief, CPS, DTM, CC
True Confessions: Ancillary Materials in a Cell Processing Lab Cell Processing Section, DTM, CC, NIH David Stroncek, MD Chief, CPS, DTM, CC Mission Provide cellular and gene therapy products and services
Quality development considerations - Regulatory perspective
Quality development considerations - Regulatory perspective CAT workshop on cell-based immunotherapies, London 15. 11.2016 Christiane Niederlaender CAT Member, MHRA An agency of the European Union Genetically
Opportunities and Challenges for Manufacturing Scale Up of CAR T Cells. Mark Dudley Institute of Medicine March 1, 2016
Opportunities and Challenges for Manufacturing Scale Up of CAR T Cells Mark Dudley Institute of Medicine March 1, 2016 Disclaimer This document represents proposals for discussion by Management. Strategies/Concepts/Projects
Adoptive cellular therapies are based on the administration of live cells into a patient in order for them to serve a therapeutic purpose.
Adoptive cellular therapies are based on the administration of live cells into a patient in order for them to serve a therapeutic purpose. Pharmaceutical products have been historically made of purified
Challenges associated with supply to larger patients populations: Elements of the CTL019 experience
Cell and Gene Therapy Challenges associated with supply to larger patients populations: Elements of the CTL019 experience Daniel Stark Head External Supply Cell- and Gene Therapies Development and Manufacturing
Integration of work flows for the generation of gene-modified cell products
Integration of work flows for the generation of gene-modified cell products Boro Dropulić, PhD, MBA Chief Science Officer and General Manager Lentigen Technology Inc., A Miltenyi Biotec Company Miltenyi
Taking CAR T-Cells From The Research Laboratory To The GMP Facility
Taking CAR T-Cells From The Research Laboratory To The GMP Facility Cliona Rooney Director of the Translational Research Laboratories (TRL) of The Center for Cell & Gene Therapy Baylor College of Medicine
IDE Submissions for Devices Used to Manufacture Cell Therapy Products
IDE Submissions for Devices Used to Manufacture Cell Therapy Products Janice Davis-Sproul, MAS Johns Hopkins Medicine 7 th Annual Somatic Cell Therapy Symposium 1 Overview Discuss an investigatorsponsored
Cell Processing at CAGT. Overview. Adrian P. Gee Center for Cell & Gene Therapy. CAGT Introduction
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 Center for Cell & Gene
Regulatory considerations for manufacturing and testing of investigational chimeric antigen receptor (CAR) T-cell products
Regulatory considerations for manufacturing and testing of investigational chimeric antigen receptor (CAR) T-cell products Xiaobin Victor Lu Product Reviewer Gene Therapies Branch DCGT/OCTGT/CBER/FDA MEASUREMENT
Ancillary Materials for Cell & Tissue Therapies Definitions, US Regulatory Approach, and USP s Risk-Tiered Approach
USP/ISCT Workshop 2012 Seattle, WA, USA Ancillary Materials for Cell & Tissue Therapies Definitions, US Regulatory Approach, and USP s Risk-Tiered Approach Elizabeth Read, MD Head of Product Development
Advancing Manufacturing for Advanced Therapies
Advancing Manufacturing for Advanced Therapies Peter Marks, MD, PhD Center For Biologics Evaluation and Research, FDA CASSS Cell & Gene Therapy Symposium July 10, 2018 Overview Cell and gene therapy products
New Methods of Expanding T Cells. Mark E. Dudley, Ph.D. Surgery Branch National Cancer Institute
New Methods of Expanding T Cells Mark E. Dudley, Ph.D. Surgery Branch National Cancer Institute Autologous T Cell and Gene Therapies Service Product New tools for T cell expansion Early clinical trials
Product Testing & Release. PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 4 th /5 th, 2006
Product Testing & Release PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 4 th /5 th, 2006 Product Testing Used to determine Safety, Purity, Identity, Potency, etc. Suitability of
From regulation to reality challenges in translation of gene therapy and cell-based medicinal products
From regulation to reality challenges in translation of gene therapy and cell-based medicinal products Gene therapy case study: ADA-SCID Alessandro Aiuti Jonathan Appleby HSR-TIGET is focused on the implementation
Assessing and Controlling Potency of Vector and Drug Product for Chimeric Antigen Receptor T Cells
Assessing and Controlling Potency of Vector and Drug Product for Chimeric Antigen Receptor T Cells David M, Hambly, Ph.D. Director, Analytical Development April 4th, 2016 Forward Looking Statements/Safe
GENERATION OF OFF-THE-SHELF TCR-LESS CAR T CELLS FROM RENEWABLE PLURIPOTENT CELLS
GENERATION OF OFF-THE-SHELF TCR-LESS CAR T CELLS FROM RENEWABLE PLURIPOTENT CELLS Bob Valamehr, PhD Vice President, Fate Therapeutics AACR Annual Meeting 2018 Press Program McCormick Place North/South
Current Japanese Regulation for Cell Therapy and NCC strategy
Current Japanese Regulation for Cell Therapy and NCC strategy National Cancer Center Hospital Department of Medical Oncology Division of Cell and Gene Therapy Yuji Heike Today s topics 1)Current Regulation
ISCT Telegraft Column: Mesenchymal Stromal Cell (MSC) Product Characterization and Potency Assay Development
ISCT Telegraft Column: Mesenchymal Stromal Cell (MSC) Product Characterization and Potency Assay Development University of Wisconsin-Madison, Production Assistance for Cellular Therapies (PACT) Over the
PRIME-XV T CELL CDM. Chemically-defined, animal component-free medium for T cell culture
T CELL CDM Chemically-defined, animal component-free medium for T cell culture Chemically-defined, animal component-free formula delivers optimal performance Optimized to support vigorous growth while
Comparability Studies for Autologous Cell Therapy Products. Chris Shen July, 2017
Comparability Studies for Autologous Cell Therapy Products Chris Shen July, 2017 Forward Looking Statements/Safe Harbor To the extent statements contained in this presentation are not descriptions of historical
COGS by Design: a systems approach to achieving commercially viable cellular therapy products. Tim Oldham 27 May 2016 ISCT 16 - Singapore
COGS by Design: a systems approach to achieving commercially viable cellular therapy products Tim Oldham 27 May 2016 ISCT 16 - Singapore Summary Identifying the total needle-to-needle cost of therapy to
Interplay of Cells involved in Therapeutic Agent Immunogenicity. Robert G. Hamilton, Ph.D., D.ABMLI Professor of Medicine and Pathology
Interplay of Cells involved in Therapeutic Agent Immunogenicity Robert G. Hamilton, Ph.D., D.ABMLI Professor of Medicine and Pathology Disclosure The author works with Amicus on an immunogenicity project
Flow Cytometric Preparation of CD34 + CD90 + Hematopoietic Stem Cells for Transplantation
Flow Cytometric Preparation of CD34 + CD9 + Hematopoietic Stem Cells for Transplantation B R YA N F OX S TA N F O R D L A B O R AT O R Y F O R C ELL & G ENE M E D I C I N E ISCT Regional Meeting Memphis,TN
Workflow for primary human NK cell isolation, xeno free expansion, harvest, and cryopreservation
Workflow for primary human NK cell isolation, xeno free expansion, harvest, and cryopreservation Many studies are evaluating natural killer (NK) cells as potential cancer treatments. However, it is challenging
Lifecycle Management: Challenges and Lessons Learned from Kymriah (CD19 CAR T)
Lifecycle Management: Challenges and Lessons Learned from Kymriah (CD19 CAR T) Anthony Thatcher, Site Head MS&T Novartis Pharmaceuticals Cell and Gene Technical Development and Manufacturing July, 2018
Update from the Center for Biologics Evaluation and Research (CBER) Peter Marks, M.D., Ph.D. GMP By The Sea 2017
Update from the Center for Biologics Evaluation and Research (CBER) Peter Marks, M.D., Ph.D. GMP By The Sea 2017 Outline Products regulated Significance of complex biologics Product and process Cutting
Strategies for Assessment of Immunotoxicology in Preclinical Drug Development
Strategies for Assessment of Immunotoxicology in Preclinical Drug Development Rebecca Brunette, PhD Scientist, Analytical Biology SNBL USA Preclinical Immunotoxicology The study of evaluating adverse effects
Cytomics in Action: Cytokine Network Cytometry
Cytomics in Action: Cytokine Network Cytometry Jonni S. Moore, Ph.D. Director, Clinical and Research Flow Cytometry and PathBioResource Associate Professor of Pathology & Laboratory Medicine University
Flow Cytometry SOP: Monocytes from Frozen Cells
Flow Cytometry SOP: Monocytes from Frozen Cells Purpose This SOP standardizes the procedure for measuring immune cells using flow cytometry in ACTG Immunology Laboratories. Materials 1. 12x75mm flow tubes
Current SCID Gene Transfer Experience
Current Perspectives on Gene Transfer for X-SCID Recombinant DNA Advisory Committee Safety Symposium March 15, 2005 Discussion Questions Current SCID Gene Transfer Experience 1. What data is available
Data Sheet ICOS/NFAT Reporter-Jurkat Recombinant Cell Line Catalog #: 79668
Data Sheet ICOS/NFAT Reporter-Jurkat Recombinant Cell Line Catalog #: 79668 Product Description Recombinant Jurkat T cell expressing firefly luciferase gene under the control of NFAT response elements
Scaling Microcarrier-based Expansion Processes for Production of High Quality Cells
Scaling Microcarrier-based Expansion Processes for Production of High Quality Cells Mark S. Szczypka BioTech 2016, Wädenswil Switzerland September 5 th 2016 This presentation is the work product of Pall
Data Sheet HVEM/NF-κB Reporter Jurkat Recombinant Cell Line Catalog # 79310
Data Sheet HVEM/NF-κB Reporter Jurkat Recombinant Cell Line Catalog # 79310 Product Description Recombinant clonal stable Jurkat T cell line expressing firefly luciferase gene under the control of 4 copies
The promise of T cell engineering CD19 CAR therapy A prologue to immune regenerative medicine Vast potential, patience, public education
The promise of T cell engineering CD19 CAR therapy A prologue to immune regenerative medicine Vast potential, patience, public education Academies Cell Therapy Workshop Washington, October 13, 2016 Michel
Challenges for Product Evaluation by Flow Cytometry for Cellular Therapy Product Processing Laboratories
Challenges for Product Evaluation by Flow Cytometry for Cellular Therapy Product Processing Laboratories C A R O LY N A. K E E V E R - TAY L O R, P H D M E D I C A L C O L L E G E O F W I S C O N S I N
An Overview of Chimeric Antigen Receptor T-cells: CAR-T-ing Away Cancer
An Overview of Chimeric Antigen Receptor T-cells: CAR-T-ing Away Cancer Maxwell Brown, PharmD Clinical Pharmacy Manager, Hematopoietic Stem Cell Transplantation NewYork-Presbyterian/Weill Cornell Medical
Hollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing.
Bioreactors and BioServices for the Life of your Proteins Hollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing. Presented by: Scott Waniger Vice President, BioServices BPI
Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies
Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies ISCT 2011 Annual Meeting Rotterdam, The Netherlands May 18 21, 2011 BioProcess Technology Consultants www.bptc.com
Comparability for Advanced Therapy Medicinal Products. Christopher A Bravery
Comparability for Advanced Therapy Medicinal Products Christopher A Bravery cbravery@advbiols.com 1 Introduction Taster for the preconference workshop Hypothetical case study to illustrate the principles
Linker p. 177 Helper Lipid p. 178 Delivery to Target Cells p. 180 Cell Entry p. 182 Receptor-Mediated Uptake p. 182 Endosomai Release p.
Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials Introduction p. 1 Roles of Regulatory Scientists p. 2 Product Development and Availability p. 2 Data Requirements
colorimetric sandwich ELISA kit datasheet
colorimetric sandwich ELISA kit datasheet For the quantitative detection of human IL6 in serum, plasma, cell culture supernatants and urine. general information Catalogue Number Product Name Species cross-reactivity
CMC Considerations for Manufacturing of CAR T-Cell Product
CMC Considerations for Manufacturing of CAR T-Cell Product November 14, 2017 Joann M. Parker, R.Ph, M.S. Regulatory Global CMC; Pfizer Inc Session: New Modalities for Cancer Moonshot: Unique Regulatory,
Data Sheet CD137/NF-κB Reporter - HEK293 Recombinant Cell Line Catalog # 79289
Data Sheet CD137/NF-κB Reporter - HEK293 Recombinant Cell Line Catalog # 79289 Background Human CD137 (4-1BB; TNFRS9) is an inducible co-stimulatory molecule that activates T cells. CD137:CD137L-mediated
Addressing Variability in Cell and Gene Therapy Manufacturing Carl Burke
Addressing Variability in Cell and Gene Therapy Manufacturing Carl Burke Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products A Workshop National Academies
Regulatory Approval of Modern Gene-Based Cancer Immunotherapies CAR T Cells A product perspective
Regulatory Approval of Modern Gene-Based Cancer Immunotherapies CAR T Cells A product perspective ASQ509 Biomed/Biotech SIG 2/1/18 Xiaobin Victor Lu Division of Cellular and Gene Therapies Office of Tissues
G-Rex Instructions for Use
WILSON WOLF MANUFACTURING CORPORATION G-Rex Instructions for Use NOTE: This document is for guidance only. You should optimize G- Rex for your particular application. APPENDIX 1: What is the key to the
ABOUT GLYCOSTEM. Company Overview
ABOUT GLYCOSTEM The company is a clinical stage biotech company established in the Netherlands in 2007. The company s headquarters and new state-of-the-art lab and production facilities are based at Pivot
Academic and Industry Partnerships
Academic and Industry Partnerships Technology Transfer and Scale-Up Stewart Abbot 8 th June 2017 Disclosure Stewart Abbot is an employee and share holder of Fate Therapeutics Inc. Fate Therapeutics Inc.
Hematopoietic Progenitor Cell Product Characterization
Hematopoietic Progenitor Cell Product Characterization Carolyn A. Taylor, Ph.D. Professor of Medicine Director of BMT Program Cell Processing Laboratory Product Testing and Characterization Goals Required
MD Anderson Cancer Center Department of Blood and Marrow Transplantation Cell Therapy Laboratory
MD Anderson Cancer Center Department of Blood and Marrow Transplantation Cell Therapy Laboratory PRODUCTS AND PROCEDURES ~ 1500 products processed per year ~ 700 products infused per year ~ > 800 Cord
Implementation of a Micro Bioreactor System for Platform Cell Culture Process Development at Cobra Biologics
Implementation of a Micro Bioreactor System for Platform Cell Culture Process Development at Cobra Biologics Kristina Lae, Scientist, Cell Culture Cobra Biologics, Södertälje, Sweden Cobra Biologics and
The Early Chimeric Antigen Receptor (CAR) T-cell Experience From An Academic Perspective. CARs: LEARNING TO DRIVE
The Early Chimeric Antigen Receptor (CAR) T-cell Experience From An Academic Perspective CARs: LEARNING TO DRIVE Jakub Svoboda, MD University of Pennsylvania Philadelphia, PA Cancer Drug Development Forum
Flow Cytometry Immune Activation SOP
Flow Cytometry Immune Activation SOP Purpose This SOP standardizes the procedure for measuring immune activation of T cells using flow cytometry in ACTG Immunology Laboratories. Materials 1. 12x75mm flow
PLATELET GUIDANCE DOCUMENT
Government of Newfoundland and Labrador Department of Health and Community Services Provincial Blood Coordinating Program PLATELET GUIDANCE DOCUMENT Office of Administrative Responsibility Director, Regional
BD MOSAIC h MSC CELL CULTURE ENVIRONMENT DEFINED SERUM FREE
BD MOSAIC h MSC CELL CULTURE ENVIRONMENT DEFINED SERUM FREE As the promise of stem cell therapy grows, so does the need for reliable tools for cell expansion in both research and clinical applications.
"From Bedside to Bench and Back: regulatory requirements for collaborations between pharma industry and academia
"From Bedside to Bench and Back: regulatory requirements for collaborations between pharma industry and academia Damir Hamamdžić D.V.M., Ph.D. Office of Research Regulatory Affairs Rutgers University RWJMS
Cell and gene therapy: scaling up and moving to mass production
EDITORIAL Cell and gene therapy: scaling up and moving to mass production Nigel Whittle In order to fulfil the promise of cell therapy, it is important that manufacture of these therapies can be industrialized
colorimetric sandwich ELISA kit datasheet
colorimetric sandwich ELISA kit datasheet For the quantitative detection of mouse Interleukin 6 (IL6) concentrations in serum, plasma and cell culture supernatants. general information Catalogue Number
Beth Hutchins, PhD PhRMA ICH Gene Therapy Discussion Group
ICH Considerations on General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors and Current Topics on Gene Therapy in USA Beth Hutchins, PhD PhRMA ICH Gene Therapy
PRIME-XV Hematopoietic Cell Basal XSFM
PRIME-XV Hematopoietic Cell Basal XSFM Xeno-free, serum-free basal medium for human hematopoietic progenitor cell culture Optimized to support vigorous expansion of hematopoietic progenitor cells while
Considerations in Product Development with Advanced Therapies and Cancer Vaccines
Considerations in Product Development with Advanced Therapies and Cancer Vaccines Thomas Hinz Head of Section Therapeutic Vaccines Paul-Ehrlich-Institut hinth@pei.de Thomas Hinz, October 29, 2008, San
FDA Perspective on the Preclinical Development of Cancer Vaccines
FDA Perspective on the Preclinical Development of Cancer Vaccines Richard D. McFarland Ph.D., M.D. Medical Officer CBER/OCTGT/DCEPT mcfarlandr@cber.fda.gov Cancer Vaccine Clinical Trials Workshop Alexandria,
ATPlite Assay Performance in Human Primary Cells
A P P L I C AT I O N N O T E Cell Viability Assays Author: Verena Brucklacher-Waldert Crescendo Biologics Cambridge, UK Assay Performance in Human Primary Cells Introduction In vitro assays using primary
Current Considerations on Chemistry, Manufacturing and Control of Cell Therapy Products (CTPs)
Current Considerations on Chemistry, Manufacturing and Control of Cell Therapy Products (CTPs) Wei Wei Ph.D Center for Drug Evaluation, National Medical Products Administration (CDE,NMPA) 2018/12/04 Tokyo
IsoFluxTM. System. The next generation of CTC Analysis is here
IsoFluxTM System The next generation of CTC Analysis is here Product Overview IsoFlux System The next generation of circulating tumor cell analysis is here The IsoFlux System enriches intact rare cells
Flow Cytometry SOP: 14 color flow for immune activation, senescence, and exhaustion
Flow Cytometry SOP: 14 color flow for immune activation, senescence, and exhaustion Purpose This SOP standardizes the procedure for measuring immune cells using flow cytometry in ACTG Immunology Laboratories.
Immunogenicity Prediction Where are we?
Pharma&Biotech Immunogenicity Prediction Where are we? European Immunogenicity Platform, 24th February 2016 Immunogenicity of Biopharmaceuticals Potential causes 2 Pre-clinical Immunogenicity Prediction
Orchard Therapeutics. Overcoming the complex challenges associated with ex vivo gene therapies. Adrien Lemoine VP Business Development & Operations
Orchard Therapeutics Overcoming the complex challenges associated with ex vivo gene therapies Adrien Lemoine VP Business Development & Operations Orchard at a glance Who we are Our mission Team Academic
For the preparation of purified mononuclear immune cells directly from whole blood PACKAGE INSERT. For In Vitro Diagnostic Use PI-TS-IVD-UK-V3
For the preparation of purified mononuclear immune cells directly from whole blood PACKAGE INSERT For In Vitro Diagnostic Use Intended Use The T-Cell Select kit is intended for the isolation of mononuclear
BalanCD HEK293 SYSTEM
BalanCD HEK293 SYSTEM Maximize productivity in suspension cultures Versatile formulation supports transfection and production including: - Rapid, scalable production of viral vectors - Use the same system
Cellular and Gene Therapy Products - CBER Update
DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTER FOR BIOLOGICS EVALUATION and RESEARCH Cellular and Gene Therapy Products - CBER Update Well Characterized Biological Products January 12-14, 2009 Kimberly
Data Sheet. TCR activator / PD-L1 - CHO Recombinant Cell line Cat. #: 60536
Data Sheet TCR activator / PD-L1 - CHO Recombinant Cell line Cat. #: 60536 Product Description Recombinant CHO-K1 cells constitutively expressing human PD-L1 (Programmed Cell Death 1 Ligand 1, CD274, B7
Immuno-Oncology Program
Immuno-Oncology Program 2018 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform
For the quantitative detection of human IL6 in serum, plasma, cell culture supernatants and urine.
m andw da a For the quantitative detection of human IL6 in serum, plasma, cell culture supernatants and urine. general information Catalogue Number Product Name Species cross-reactivity Range (calibration
Clinical Applications of Mesenchymal Stromal Cells
Clinical Applications of Mesenchymal Stromal Cells John Girdlestone PhD Head of Laboratory Cellular and Molecular Therapies NHSBT Oxford Cellular and Molecular Therapies 7 HTA-licensed Cell Therapy Laboratories
Data Sheet PD-1 / NFAT - Reporter - Jurkat Recombinant Cell Line Catalog #: 60535
Data Sheet PD-1 / NFAT - Reporter - Jurkat Recombinant Cell Line Catalog #: 60535 Product Description Recombinant Jurkat T cell expressing firefly luciferase gene under the control of NFAT response elements
For the preparation of purified mononuclear immune cells directly from whole blood PACKAGE INSERT. For In Vitro Diagnostic Use PI-TS-IVD-UK-V4
For the preparation of purified mononuclear immune cells directly from whole blood PACKAGE INSERT For In Vitro Diagnostic Use Intended Use The T-Cell Select kit is intended for the isolation of mononuclear
BalanCD HEK293 SYSTEM
BalanCD HEK293 SYSTEM Maximize productivity in suspension cultures Versatile formulation supports transfection and production including: - Rapid, scalable production of viral vectors - Use the same system
BD Resurge Media Supplements Chemically Defined. Protein Free. Animal Free.
D Resurge Media Supplements Chemically Defined. Protein Free. nimal Free. Overview Cell-based production of active pharmaceutical ingredients generally requires supplementation of cell culture media to
Corporate Tutorial IBA T-CATCH. Cell isolation in pipette tips. ISCT, Paris Lothar Germeroth
Corporate Tutorial IBA T-CATCH Cell isolation in pipette tips ISCT, Paris 2014 Lothar Germeroth Workshop IBA Introduction of the Streptamer technology Staining with Streptamers off rate assay T-CATCH Cell
Cell Characterization: Developing Assays to Address the Biological Parameters of Identity and Potency
Cell Characterization: Developing Assays to Address the Biological Parameters of Identity and Potency Jessica Carmen Ph.D and Jon Rowley Ph.D., LBS-TCS, May 2011 Disclaimer Certain matters discussed in
Human IL10RB ELISA Pair Set ( CRFB4 )
Human IL10RB ELISA Pair Set ( CRFB4 ) Catalog Number : SEK10945 To achieve the best assay results, this manual must be read carefully before using this product and the assay is run as summarized in the
G-Rex Instructions for Use
WILSON WOLF MANUFACTURING CORPORATION G-Rex Instructions for Use NOTE: This document is for guidance only. You should optimize G- Rex for your particular application. 10/30/2013 Frequently Asked Questions
T-cell engineering for adoptive immunotherapy using TALeffector. Sophie Derniame PhD Project Leader, CellectisTherapeutics
T-cell engineering for adoptive immunotherapy using TALeffector nucleases (TALEN ) Sophie Derniame PhD Project Leader, CellectisTherapeutics FORWARD LOOKING STATEMENT This communication expressly or implicitly
Engage with us on Twitter: #Molecule2Miracle
Engage with us on Twitter: #Molecule2Miracle Kassy Perry President & CEO Perry Communications Group PhRMA Alliance Development Consultant.@kassyperry Emily Burke, Ph.D. Director of Curriculum BioTech
GSI Canine IL-12 ELISA Kit DataSheet
Interleukin 12 (IL12) is the founding member of the IL12 family of heterodimeric cytokines, which have important immunological functions. IL12 is composed of two disulfidelinked subunits of 35 kda and
Precigen Company Update
Precigen Company Update Helen Sabzevari, PhD President, Precigen 9 January 2019 JP Morgan 37 th Annual Healthcare Conference Forward-looking statements Precigen, Inc. is a subsidiary of Intrexon Corporation
Investigations in Immune Suppression for Monoclonal Antibody Therapeutics
Investigations in Immune Suppression for Monoclonal Antibody Therapeutics Vibha Jawa Principal Scientist AAPS NBC Meeting, May 2016 Clinical Immunology, Medical Sciences, Amgen Background Therapeutic proteins
Whitepaper. Small Molecule Vs Cell Therapy Clinical Trial Supply Chain. Martin Lamb, Executive Vice President for Sales and Marketing
Small Molecule Vs Cell Therapy Clinical Trial Supply Chain Page 1 Whitepaper Small Molecule Vs Cell Therapy Clinical Trial Supply Chain Martin Lamb, Executive Vice President for Sales and Marketing Small
Webinar Series. Don't get lost in translation: How smart design and technology are enabling benchto-bedside in translational research
Don't get lost in translation: How smart design and technology are enabling benchto-bedside in translational research October 14, 2015 Webinar Series Brought to you by the Science/ AAAS Custom Publishing
Thermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production
Thermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production May/June 2013 1 The world leader in serving science Agenda
Update from the Center for Biologics Evaluation and Research (CBER): Advancing the Development of Complex Biologic Products
Update from the Center for Biologics Evaluation and Research (CBER): Advancing the Development of Complex Biologic Products Peter Marks, M.D., Ph.D. FDLI 2017 Outline Products regulated Significance of
Comparison of three cytokine release assays (CRA) for hazard. syndrome potential of monoclonal
Comparison of three cytokine release assays (CRA) for hazard identification of cytokine release syndrome potential of monoclonal antibody (mab) therapeutics ti Madeline Fort HESI ITC Cytokine Release Assay
Cancer Research. Peptide Innovations in. Neo-Epitope Analysis Immunotherapy Cancer Proteomics Enzyme Profiling Epigenetics
Peptide Innovations in Cancer Research Neo-Epitope Analysis Immunotherapy Cancer Proteomics Enzyme Profiling Epigenetics Innovative Peptide Solutions Neo-Epitope Analysis Neo-epitopes encoded by the mutanome
Designing Technologies to Meet the Manufacturing Needs of New Regenerative Therapies
National Academy of Science Engineering Medicine 2017 RM workshop Designing Technologies to Meet the Manufacturing Needs of New Regenerative Therapies Isabelle Rivière, PhD Director, Michael G. Harris
PRIME-XV Cell Therapy Products by
PRIME-XV Cell Therapy Products by Product List 2017 TRINOVA BIOCHEM now distributes the PRIME-XV Cell Therapy line by Irvine Scientific in Germany, Austria and Switzerland. Irvine Scientific is a worldwide
Good Manufacturing Practice Production of Human Stem Cells for Somatic Cell and Gene Therapy
Good Manufacturing Practice Production of Human Stem Cells for Somatic Cell and Gene Therapy ROLAND BOSSE, MONIKA SINGHOFER-WOWRA, FELICIA ROSENTHAL, GREGOR SCHULZ CellGenix Technologie Transfer AG, Freiburg,
Nature Biotechnology: doi: /nbt.4086
Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3 p815 p815-hcd2 Ag (-) anti-cd3