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HemaCare社 製品概要
- 1. HemaCare® Product Features Comprehensive Products& Services for BioResearch & Cellular Therapy 2017
- 2. HemaCare:HemaCare: Leading Providerof Apheresis Products,Leading Provider of Apheresis Products, Blood Cells, & Apheresis CollectionBlood Cells, & Apheresis Collection ServicesServices • Market leader – 250,000 apheresis procedures – Over 39 years experience in blood collection and banking • Apheresis collections & human-derived blood components – Preclinical & clinical applications • Biologics • Immunotherapy • Cell therapy • Assay development • Medical devices • Support preclinical research, clinical studies from Phase I to Phase III, & commercialization – Recognized by Dendreon as a top apheresis collection performer for PROVENGE® cell therapy Headquarters Los Angeles, California
- 3. HemaCare Quality Advantage:HemaCareQuality Advantage: Our Donors Make the DIFFERENCEOur Donors Make the DIFFERENCE Highly Characterized Donor Database •We know our donors Recall donors / repeat collections •They are qualified & tested for each donation Qualification, serological, & infectious testing performed •We can recruit donors for specific investigator needs Age, gender, height, weight, ethnicity Medical history – vaccinations, diet, family history Lifestyle characteristics HLA type HIV, HepA, HepB, CMV testing All donors are qualified per FDA regulations & IRB-approved informed consent.
- 4. HemaCare Products &ServicesHemaCare Products & Services • Human-derived Primary Cells – Peripheral Blood (healthy & disease state) – Mobilized Peripheral Blood – Bone Marrow – Cord Blood • Tissue Specimens • Preservation Media • Cellular Therapy Solutions – Leukapheresis collections for: • Process development • Immuno-cellular therapy clinical trials • Commercial immuno-cellular therapy (i.e. PROVENGE®)
- 5. Tissue SourcesTissue Sources •Cord Blood – Desirable for high CD34+ cells. – Difficult to obtain, must be obtained <24hours post-delivery – Small volume, up to ~100 ml – Difficult to guarantee cell count/viability • Peripheral Blood (Apheresis or Whole Blood) – Easily acquired from donors – Low CD34+ cells – Includes leukopak, selected cell products – Best for PBMC, mononuclear cells and polynuclear cells • Mobilized Peripheral Blood (Apherisis or Whole Blood) – Very high WBC count, same as peripheral blood profile – Expensive to obtain- cost of treatment, extra donor payment • Bone Marrow – High CD34+ count – Limited volume, 100 ml maximum – Expensive
- 6. Apheresis CollectionApheresis Collection TheHemaCare Advantage •Established collection center •Rapidly add new centers as needed •Standardized protocols & procedures across all sites •24/7/365 support from clinical, logistics, regulatory, & training experts •Single point of contact • Ability to optimize cell collection by controlling & qualifying the apheresis processes based on cGMP & cGTP principles • Use of clinical-grade, serum-free, protein-free preservation media such as HypoThermosol® & CryoStor® enables worldwide shipment of fresh or frozen cellular products, extending shelf-life of cells
- 7. Apheresis Collection-Apheresis Collection- Stateof the art technologyState of the art technology • Based upon unique centrifugal technology • Allows for distinct separation of whole blood plasma-red blood cells-white blood cells • Selected removal of targeted components into collection bag • Return remaining blood components to the donor Terumo Optia COBE Spectra Industry standard >20 years
- 8. Healthy Human-derived PrimaryCellsHealthy Human-derived Primary Cells Peripheral BloodPeripheral Blood Mobilized Peripheral Blood Mobilized Peripheral Blood Bone MarrowBone Marrow Cord BloodCord Blood Cryopreserved and Fresh available for many products. Positive or Negative cell selection protocols
- 9. Disease State PrimaryCellsDisease State Primary Cells Largest Selection of Disease State Cells Available Verified medical diagnosis Largest Selection of Disease State Cells Available Verified medical diagnosis Cancer •Acute Myeloid Leukemia (AML) •Breast Cancer •Chronic Lymphocytic Leukemia (CLL) •Colorectal Cancer •Gastric Cancer •Lung Cancer •Multiple Myeloma •Non-Hodgkin’s Lymphoma •Prostate Cancer Inflammatory Bowel Disease •Crohn's Disease Infectious Disease •Hepatitis B Virus (HBV) •Hepatitis C Virus (HCV) •Herpes Simplex Virus 1 •Herpes Simplex Virus 2 •Human Immunodeficiency Virus (HIV) •Syphilis Autoimmune Disease •Diabetes Mellitus Type 2 •Rheumatoid Arthritis •Systemic Lupus Erythematosus (SLE) Genetic Disease •Sickle Cell Anemia •Beta Thalessemia Don’t see what you need? – Just ask! We are continuously adding donors. This is a product group that is growing very fast- we see increased demand from customers.
- 10. Key ApplicationsKey Applications NormalPeripheral Blood (Leukopaks, PBMCs)Normal Peripheral Blood (Leukopaks, PBMCs) Mononuclear Cells (primarily lymphocytes and monocytes) •Immunology and immunotherapy R&D – Cancer – Autoimmune disease – Diabetes – HIV, Viral response – Other •Drug Discovery and Validation – Mixed lymphocyte reactions – ADME-Toxicity – Antigen presentation testing – SCID Mice •Cell analytics/assay instruments – Development – Qualification Lymphocytes Specifically •Regulatory T-cell immunotherapy •CAR T-cell immunotherapy •Drug response (mixed lymphocyte reaction) Monocytes Specifically •Generate dendritic cells for dendritic cell vaccines (see our white paper on PBMC applications)
- 11. Peripheral Blood MononuclearCells (PBMC)Peripheral Blood Mononuclear Cells (PBMC) Extracted from whole blood using ficoll gradient Any PB cell with round nucleus Lymphocytes + Monocytes
- 12. Applications for PBMCin Drug Discovery and DevelopmentApplications for PBMC in Drug Discovery and Development • Screen for genetic variation, inflammation response – Test drug effect on different donor’s cells for immune response • Antibody-mediated cellular cytotoxicity (ADCC) assays – Drug discovery for regulation of cytotoxic T cells • Mixed lymphocyte reactions • Adverse drug reactions related to immune response – Testing for ADR for drug before release • Humanized mice models for drug effectiveness and toxicity – Transplant human immune system into mice using PBMC Sources for mononuclear cells •Peripheral blood •Mobilized peripheral blood •Bone marrow •Cord blood
- 13. T-Lymphocytes (T-cells)T-Lymphocytes (T-cells) 13 CD3+,CD56-, T Cell Markers: CD4+ -Helper T Cell CD8+ -Cytotoxic T Cell CD4,CD25, - T Regulatory Cell CD16, CD56, CD3-, CD31, CD30 n = 6 Effector- actively respond to stimulation –helper, killer, regulatory cells. Helper (TH)- assist B cell maturation, activate cytotoxic T cells, and macrophages Cytotoxic (killer)- bind to virus-infected cells and tumor cells and destroy them Memory – previously stimulated by foreign antigen, retain activity to that antigen, are long-lived, and propagate to form effector cells Regulatory (suppressor)
- 14. Natural Killer (NK)CellsNatural Killer (NK) Cells 14 Sources for NK Cells •Peripheral blood •Cord blood n = % Purity 96.3% 93.0% Cytotoxic Lymphocytes- provide rapid response to viral infection. Recognize cells presenting foreign antigen, bind to infected (or tumor) cells and destroy them. CD16+, CD56+
- 15. B Lymphocytes (B-Cells)BLymphocytes (B-Cells) 15 Sources for B-cells •Peripheral blood •Cord blood • Secrete antibodies that bind to foreign antigen, stimulate immune response to infected or tumor cells • Present foreign antigen on their surface for activation of T lymphocytes • CD19+
- 16. MonocytesMonocytes 16 Sources for Monocytes •Peripheralblood •Mobilized peripheral blood •Cord blood n = 6 • Largest white blood cells, can differentiate into macrophages, and myeloid dendritic cells. • CD14+, CD16+, CD64 • Produce cytokines that stimulate inflammation
- 17. MacrophagesMacrophages (M1 andM2, monocyte derived)(M1 and M2, monocyte derived) 17 n = 5 White blood cell that engulfs and digests cell debris, microbes Present antigen to T cells, stimulate T cell response M1 increase inflammation M2 decrease inflammation CD11b, CD68, CD163
- 18. Dendritic CellsDendritic Cells 18 Sourcesfor Dendritic Cells •Peripheral blood •Cord blood Dendritic Cells (DC) are derived from purified CD14+ Monocytes which are cultured in the presence of GM-CSF and IL-4 for 7 days and then harvested. CD1c+, CD83+, CD141+ • Primary function of dendritic cells is to present antigen to T cells and stimulate an immune response. • Highly present in tissue exposed to external environment- skin, nose, lungs, digestive tract. • They are used in vaccine research and developent to identify specific antigen that stimulates immune response.
- 19. NeutrophilsNeutrophils 19 Sources for Neutrophils •Peripheralblood •Cord blood Most abundant white blood cell in human blood Phagocytic cells, kill foreign cells Recruited to sites of injury, acute inflammation CD16a+, CD16b+
- 20. Stem/Progenitor Cell ProductsStem/ProgenitorCell Products 20 Sources for Stem/Progenitor Cells (CD34+/CD133+) •Mobilized peripheral blood •Bone Marrow •Cord blood n = 5 Multi-potent cells, source of lymphoid and myeloid (hematopoietic) cells (white paper to be released in October, 2017)
- 21. Biopreservation MediaBiopreservation Media Successin the regenerative medicine, biobanking, and drug discovery industries depends on the shelf life and viability of cells, tissues, and organs designated for research or clinical applications. CryoStor® Pre-formulated with 2, 5, 10%, or a custom volume of USP- grade DMSO, CryoStor yields superior post-thaw cell viability, recovery, and function. Serum- free and protein-free! HypoThermosol® Protein-free, serum-free hypothermic storage media are designed for maximum shelf life and shipping stability at 2-8°C.
- 22. HemaCare High QualityLeukapheresis Raw MaterialHemaCare High Quality Leukapheresis Raw Material Full Leukopak Count (x106 ) ± SD Total Nucleated Cells 14,400 550 Mononuclear Cells 12,100 600 n= 1,202 leukapheresis products
- 23. Fresh or FrozenLeukopak- unique offeringFresh or Frozen Leukopak- unique offering • HemaCare is the only provider of cryopreserved leukopak – Use on demand – Multiple portions for use at different times – High recovery and viability – Desirable for allogeneic cell therapy development, or cell expansion protocols
- 24. Thank You! Visit usat www.hemacare.com
Editor's Notes
- #16 Positively selected viable CD19 B cells via immuno-magnetic separation. The CD19 marker becomes saturated during the process. The CD20 or CD22 B cell marker can be used for a purity check.
- #20 The light blue line represents: neutrophil only The red line represents: neutrophil with non-opsonized E. coli-FITC particles The black line represents: neutrophil with opsonized E. coli-FITC particles The light blue line represents: neutrophil only The red line represents: neutrophil with DHR The black line represents: PMA activated neutrophil with DHR