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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.
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.
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
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.
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