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• Started as a blood bank 37 years ago
• Transformed from blood banking and therapeutic apheresis services to bioresearch and cell therapy focus
• Leading provider of apheresis products, human blood cells, and apheresis collection services
• Support preclinical research, clinical studies from Phase I to Phase III, and commercialization
we?are
Whowe?
Our History
Founded as a blood bank
Began therapeutic
apheresis operations
Participated in leukapheresis
clinical trial collections and
stem cell collection programs
Partnered with Dendreon to
provide apheresis
materials for test runs and began cellular
therapy clinical trial collections
Began Provenge® patient collections
Created BioResearch Products & Services
Launched Cell Therapy Solutions portfolio
Ability to provide apheresis starting
material for cell therapy process development
1970s 1980s 1990s 2000s 2010s
The HemaCare Advantage
Accreditations• FDA registered donor center with cGMP and cGTP requirements• State of California – Biologics Production and Clinical Lab• AABB and CLIA accredited• Joint Commission, FACT, DHS, and OSHA compliant
A comprehensive research and cellular therapy offering• Variety of healthy and disease state human derived products• Comprehensive cell therapy products and services• Cell manufacturing process development• Customized cell processing projects• Cold chain management• Apheresis consulting
Our Donors Make The Difference
Donors are the critical source for any research project. We have been recruiting and developing our own healthy donor pool since 1978.
Pedigreed Donor DatabaseWe know our donors
Recall donors / repeat collections
They are qualified and tested each donation Qualification, serological and 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, other specific laboratory test results Other specific parameters
All donors are qualified per FDA regulations and IRB-approved informed consent.
Products and Services
HUMAN-DERIVED PRIMARY CELLS
BIOPRESERVATION MEDIA
CELLULAR THERAPY SOLUTIONS
• Peripheral Blood• Mobilized
Peripheral Blood• Bone Marrow• Cord Blood
Leukapheresis collections for:• Process development• Immuno-cellular therapy clinical trials• Commercial immuno-cellular therapy (i.e. PROVENGE®)
• Cryostor CS10®• Hypothermosol®
Human-derived Primary Cells
Peripheral Blood
• Leukopaks• Platelets• Whole Blood• Plasma• Serum• Mononuclear Cells• CD3 Pan T Cells• CD4 Helper T Cells• CD8 Cytotoxic T
Cells• CD14 Monocytes• CD19 B Cells• CD4/CD25
Regulatory T Cells• CD56 NK Cells• Dendritic Cells• Macrophages• Neutrophils
Mobilized Peripheral Blood
• Mononuclear Cells• CD14 Monocytes• CD34 Stem Cells• CD34 Depleted
Mononuclear Cells• CD133 Stem Cells
Bone Marrow
• Unprocessed Bone Marrow
• Mononuclear Cells• Mesenchymal Stem
Cells• CD34 Stem Cells• CD34 Depleted
Mononuclear Cells• CD133 Stem Cells
Cord Blood
• Unprocessed Cord Blood
• Mononuclear Cells• CD3 Pan T Cells• CD4 Helper T Cells• CD8 Cytotoxic T
Cells• CD14 Monocytes• CD19 B Cells• CD34 Stem Cells• CD133 Stem Cells• CD56 NK Cells• Neutrophils• Mesenchymal Stem
Cells• Plasma• Dendritic Cells
(CD34 derived)
Human-derived Primary Cells
Human-derived Primary CellsDisease-state Primary CellsHemaCare provides disease-state biological products from the following
indications:(more indications are continuously added)
Autoimmune Disease• Diabetes Mellitus Type 2• Rheumatoid Arthritis• Systemic Lupus Erythematosus (SLE)
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
Customizable
Targeted Donor RecruitmentOur diverse donor pool enables us to provide the match customers need to successfully complete their study:
• Healthy donors• Disease-state donors and patients• HLA specific (low and high resolution)• CMV negative/positive• Blood type specific• Diverse demographics• Gender and/or age specific• Specific lifestyle characteristics• Ability to provide both repeat and unique donors
All products are collected from donors and patients who are qualified for participation in accordance with Institutional Review Board (IRB)-approved informed consents.
Customizable
Customized Collections And Cell/Tissue ProcessingFollowing cGMP and cGTP collection guidelines is key to successful research. We provide:
• Protocol-specific collections - Your Way• Fulfillment of specific cell requests• Multiple cell types from same donor• Density separation of white blood cells• Positive or negative immunomagnetic cell selection methods• Custom primary cell cultures• Fresh or frozen cell formats• Custom cell number/volume per unit• Packaging and shipping to customer specifications (i.e. shipping media, buffers,
containers)• Cold chain services for shipments anywhere globally
Count (x106) ± SD
Total Nucleated Cells 14,400 550
Mononuclear Cells 12,100 600
n= 1,202 leukapheresis products
High-quality Leukapheresis Raw Material Collected at HemaCare
Peripheral Blood Mononuclear Cells (PBMCs)
Sources for Mononuclear cells• Peripheral blood• Mobilized peripheral blood• Bone Marrow• Cord blood
n = 20
Best in Class Partners = High Quality Products
HemaCare aligns itself with partners who maintain high quality standards
HypoThermosol® and CryoStor®.
Prodigy®, CliniMACS®, and AutoMACS®
CoolCell®
Cellular Therapy Solutions
Apheresis Collection Network
Cold Chain and Logistics
Cryopreservation and Biopreservation Services
Patient Collections within a Standardized
Apheresis Network
Process Development Clinical Trials
A highly flexible, modularized portfolio of Cellular Therapy Solutions
Customized Apheresis for Process
Development• CAR-T comparability runs• Fresh and frozen• Customized to meet varying
donor specs (e.g. high neutrophils)
CommercializationClinical Trials Process Development
Apheresis Expertise in a Quality Systems Framework
Optimize cell collection by controlling and qualifying the apheresis processes based on cGMP and cGTP requirements• Qualification of donors • Qualification of vendors, equipment, supplies and sites• Monitoring equipment, supplies and environment • Development and maintenance of procedures• Comprehensive staff training and qualification• Documentation and records management• Management of exceptions and deviations• Monitoring quality indicators for process improvement• Internal and external inspections
Apheresis Collection Network
The HemaCare Advantage• Established network of collection centers• Standardized protocols and procedures across
all sites • 24/7/365 support from clinical, logistics,
regulatory, and training experts• Single point of contact
Apheresis Collection Network
Vision: A Global Solution• HemaCare is building partnerships that can be
leveraged to support clinical trials globally • Working toward providing the same level of
standardization on a global scale as you would expect from US based collection centers
• Leverage biopreservation experience and partnerships to maintain product integrity during global transport
Logistics Management
The HemaCare Advantage• Strict oversight of temperature to cold chain
logistics• Complete oversight of samples from
collection to final destination• Best-in-class clinical grade biopreservation
media– Cryostor® CS10– Hypothermosol® FRS
• Global manage transport of collection samples
Cryopreservation and Storage Support
The HemaCare Advantage• Cryopreservation and storage (Cryostor®
CS10) • Just-in-time shipment upon request
• Close cooperation with QA and Operations staff to assure quality, control, and chain of custody
Cryostor®
Clinical grade freeze media made under cGMP to device and
relevant drug standards
At Hemacare, we're not just about the science. We are committed to charting a path of growth by expanding our comprehensive portfolio of research and cell therapy products that will touch the lives of patients everywhere.
We demonstrate this through a compelling value proposition that cannot be easily replicated:
• Vertically integrated supplier to the industry• FDA-registered, cGMP and cGTP clinical collection capabilities• Donor management and apheresis collection expertise spanning• 37 years of performing over 250,000 collections
GROW WITH US!
In Conclusion…