HemaCare BioResearch: Capabilities and

Applications Marjorie Smithhisler, Business Development

Executive, EastGeorge Eastwood, Regional Vice President – East

Coast SalesLou Juliano, SVP – Global Sales and Business

DevelopmentTrish Hollenbeck, Field Sales Liaison

June 1st, 2015

HemaCare Corporation

• Market leader • 250,000 apheresis procedures • 30 years

• Provides apheresis collections and human-derived blood components for • preclinical and clinical applications in

• biologics • immunotherapy• cell therapy• assay development, and • medical devices

• Support preclinical research, clinical studies from Phase I to Phase III, and commercialization • Recognized three years in a row by Dendreon as a top apheresis collection performer

for PROVENGE®, the only FDA-approved cellular immunotherapy product

Leading provider of apheresis products, human blood cells, and

apheresis collection services.

Our History

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Founded as a blood bank

Began therapeutic

apheresis operations

Participated in

leukapheresis clinical trial collections

and stem cell collections programs

Partnered with

Dendreon to provide

apheresis materials for test runs and

began cellular therapy

clinical trial collections

Began Provenge®

patient collections

Expanded the BioResearch Products and

Services Division

1970’s

1980’s

1990’s

2000’s

2010’s

The HemaCare Advantage

Accreditations• FDA registered with cGMP and cGTP requirements• State of California – Biologics Production and Clinical Lab• AABB and CLIA accredited• Joint Commission, FACT, DHS, and OSHA compliant

World Class Scientific Advisory Board• Scott Burger, M.D. – Chairman; Advanced Cell & Gene

Therapy, LLC• Mahendra Rao, M.D., Ph.D. – The New York Stem Cell

Foundation• Aby Mathew, Ph.D. – CTO; BioLife Solutions, Inc.• Stephen Minger, Ph.D. – Global Head of Research; GE

Healthcare

A comprehensive research and cellular therapy offering

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HemaCare Strengths and Capabilities

• Comprehensive apheresis expertise and leadership– Over 250,000 apheresis procedures successfully performed– Over two decades of experience operating the Cobe Spectra for

apheresis collections– Scientific Advisory Board comprised of diverse international cell

therapy and cryopreservation/cold chain management experience

• Extensive repeat “normal” donor registry– Various demographics and ethnicities– Supports repeat requests for desirable donor isolated cell products

• Cell isolation and cryopreservation expertise – Various positive and negative magnetic selection– Cryopreservation using state of the art equipment and best in

class products• Controlled rate freezing• Cryostor cryopreservation media (BioLife Solutions)

HemaCare Strengths and Capabilities

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.

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HemaCare Strengths and Capabilities

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

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HemaCare BioResearch Laboratory• Research applications include basic biologics,

immunotherapy, cell therapy, assay development, and medical devices

• Utilizing HemaCare’s long-standing, well-controlled donor pool as starting material, our cell isolation/processing lab is able to manufacture the following products:

Raw Blood Materials

− Apheresis Collections (10 x 109 TNC

− Whole blood

− Plasma, serum

− Bone marrow

− Cord blood

− G-CSF-mobilized PBSC

Processed Blood Derived Materials

− PBMCs

− Purified Cell subpopulations• CD3, CD4, CD8, CD19, CD56,

etc.

− Cultured Cells• Macrophages, Dendritic cells,

T reg

− Stem Cells• CD34, CD133, MSC

ProductsHuman-derived Primary Cells• Human-derived biological products (healthy and

disease state)– Peripheral Blood– Mobilized Peripheral Blood– Bone Marrow– Cord Blood

Tissue Specimens• FFPE blocks• Fine needle aspirates

Biopreservation MediaCustom Services

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Human-derived Primary Cells

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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)

Disease-state Primary Cells

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HemaCare 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

Successful Customer Projects• Dendritic Cells (DC’s)

- Customer expresses interest in large lots of DC’s- HemaCare works with requestor) to optimize characterization of

DC’s- Creation and purchase of original 100 vial lot- Successful application of cells results in recalling donor to

produce additional lot- Further optimized DC culture conditions to generate larger batch

sizes (~200 vials per lot)- Proactively scheduled future collections from donor to increase inventory

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Successful Customer Projects Cont’d

• CD4+ T Cells- Customer inquires in regards to availability of CD4+ T cells

- 2 large inventory lots are selected and 4 vials of each lot are purchased

- Remaining vials for each lot are placed on temporary hold

- Upon successful evaluation in assay remaining vials from each lot are purchased and shipped

- Donor recalled for CD4+ specific isolation, which results in ~140 million CD4+ T Cells

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Successful Customer Projects Cont’d

• Custom Leukopak Separations

-CD8 T Cells, CD56NK Cells, and monocyte-derived DC’s from a single collection

- Custom splitting of apheresis collection in order to cryopreserve PBMC’s at requested custom aliquot size for half of a collection, with other half of collection utilized for dendritic cell generation

- Full apheresis collection with additional volume drawn for generation of DC’s for donor specific evaluation

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