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HemaCare®
Product Features
Comprehensive Products & Services
for BioResearch & Cellular Therapy
2017
HemaCare:HemaCare: Leading Provider of 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
HemaCare Quality Advantage:HemaCare Quality 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.
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®)
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
Apheresis CollectionApheresis Collection
The HemaCare 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
Apheresis Collection-Apheresis Collection-
State of 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
Healthy Human-derived Primary CellsHealthy 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
Disease State Primary CellsDisease 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.
Key ApplicationsKey Applications
Normal Peripheral 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)
Peripheral Blood Mononuclear Cells (PBMC)Peripheral Blood Mononuclear Cells (PBMC)
Extracted from whole blood using ficoll gradient
Any PB cell with round nucleus
Lymphocytes + Monocytes
Applications for PBMC in 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
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)
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+
B Lymphocytes (B-Cells)B Lymphocytes (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+
MonocytesMonocytes
16
Sources for Monocytes
•Peripheral blood
•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
MacrophagesMacrophages (M1 and M2, 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
Dendritic CellsDendritic Cells
18
Sources for 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.
NeutrophilsNeutrophils
19
Sources for Neutrophils
•Peripheral blood
•Cord blood
Most abundant white blood cell in human blood
Phagocytic cells, kill foreign cells
Recruited to sites of injury, acute inflammation
CD16a+, CD16b+
Stem/Progenitor Cell ProductsStem/Progenitor Cell 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)
Biopreservation MediaBiopreservation Media
Success in 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.
HemaCare High Quality Leukapheresis 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
Fresh or Frozen Leukopak- 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
Thank You!
Visit us at www.hemacare.com

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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 Provider of 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:HemaCare Quality 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 The HemaCare 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- State of 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 Primary CellsHealthy 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 Primary CellsDisease 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 Normal Peripheral 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 Mononuclear Cells (PBMC)Peripheral Blood Mononuclear Cells (PBMC) Extracted from whole blood using ficoll gradient Any PB cell with round nucleus Lymphocytes + Monocytes
  • 12. Applications for PBMC in 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)B Lymphocytes (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 •Peripheral blood •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 and M2, 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 Sources for 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 •Peripheral blood •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/Progenitor Cell 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 Success in 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 Quality Leukapheresis 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 Frozen Leukopak- 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 us at www.hemacare.com

Editor's Notes

  1. 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.
  2. 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