HemaCare CorporationHemaCare CorporationCompany OverviewCompany Overview

Comprehensive Product and Service Solutions for

BioResearch and Cellular Therapy

2015

HemaCare CorporationHemaCare 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 HistoryOur 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 AdvantageThe 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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The HemaCare AdvantageThe HemaCare AdvantageOur Donors Make The DifferenceOur Donors Make The Difference

Donors are the critical source for any research project.Recruited and developed our own healthy donor pool since 1978

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Pedigreed Donor Database•We 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.

How HemaCare Participates in the How HemaCare Participates in the Research and Cellular Therapy Value Research and Cellular Therapy Value

Chain ContinuumChain Continuum

• Pre-trial studies• Research and development

using cells• Cell manufacturing process

development• Cell processing• Cell isolation/purification• Testing (development &

qualifying analytical devices & equipment)

• Apheresis collection• CRO/consulting• Cell manufacturing process

development• Testing (development &

qualifying analytical devices & equipment)

• Apheresis collection• Cell manufacturing process

development• Testing (development &

qualifying analytical devices & equipment)

• Apheresis products (normal & mobilized)• PBMCs (fresh & frozen)• Purified cells (fresh & frozen)

• Bone marrow products• Cord blood products• Disease state cells & plasma• Characterized PBMCs• Customized cell processing

projects• Contract laboratory services• Cryopreservation/biobanking• Global sourcing and distribution

• Apheresis collection• National Network

• Apheresis consulting• Consulting services• Logistics• Distribution• Cold chain management

• Contract laboratory services

• Apheresis collection• National Network

• Apheresis consulting• Consulting services• Logistics• Distribution• Cold chain management

• Contract laboratory services

• Disease state tissues• Contract cell manufacturing

services

• Contract cell manufacturing services

• CRO partnerships & alliances

• Contract cell manufacturing services

Value Chain Activities

Current HemaCare Product and Services

Future Vision for HemaCare Product and Services

HemaCare BioResearch CustomersHemaCare BioResearch Customers - -

ConfidentialConfidential

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Products and ServicesProducts and Services

Human-derived Primary Cells (healthy and disease state)•Peripheral Blood

•Mobilized Peripheral Blood

•Bone Marrow

•Cord Blood

Tissue Specimens

Biopreservation Media

Cellular Therapy Solutions• Leukapheresis collections for:

– Process development

– Immuno-cellular therapy clinical trials

– Commercial immuno-cellular therapy (i.e. PROVENGE®)

Human-derived Primary CellsHuman-derived Primary Cells

Human-derived Primary CellsHuman-derived Primary Cells

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Peripheral BloodPeripheral Blood Mobilized Peripheral Blood

Mobilized Peripheral Blood Bone MarrowBone Marrow Cord BloodCord Blood

Disease-state Primary CellsDisease-state Primary Cells

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HemaCare provides disease-state biological products from the following indications:

(more indications are continuously added)

HemaCare provides disease-state biological products from the following indications:

(more indications are continuously added)

CustomizableCustomizable

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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CustomizableCustomizable

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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Human Cells: Standardizing Living Human Cells: Standardizing Living Biological Raw Material Through Biological Raw Material Through

Quality ProcessesQuality Processes

The quality and consistency of Human blood-derived cells are critical to enable research for cell therapy, tissue-engineered products, and ex vivo gene therapy products.

Controlling cell collections

Training

Experienced staff

Quality Systems

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Best In Class Partners = High Best In Class Partners = High Quality Products Quality Products

HemaCare aligns itself with partners with high quality standards

•BioLife Solutions: HypoThermosol® and CryoStor®.

•Miltenyi Biotec: Prodigy®, CliniMACS®, and AutoMACS®

•BioCision: CoolCell®

High-quality Leukapheresis Raw High-quality Leukapheresis Raw Material Collected at HemaCareMaterial Collected at HemaCare

Count (x106)

± SD

Total Nucleated Cells

14,400 550

Mononuclear Cells 12,100 600

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n= 1,202 leukapheresis products

Longevity Study - LeukoPakLongevity Study - LeukoPak

Actual Viable Cell Count in Autologous Plasma

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Peripheral Blood Mononuclear Cells Peripheral Blood Mononuclear Cells (PBMCs)(PBMCs)

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Sources for Mononuclear cells•Peripheral blood•Mobilized peripheral blood•Bone Marrow•Cord blood

n = 20

Cryopreserved PBMC Functional Cryopreserved PBMC Functional Assay: Assay:

CMV CultureCMV Culture

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INF-γ and TNF-α intracellular staining on day 6 PBMCs stimulated with CMV peptide

Cellular Therapy SolutionsCellular Therapy Solutions

Cellular Therapy SolutionsCellular Therapy Solutions

Customized Apheresis for

Process Development

Apheresis Collection Network

Cold Chain and Logistics

Cryopreservation and

Biopreservation Services

Patient Collections within a

Standardized Apheresis Network

A highly flexible, modularized portfolio of Cellular Therapy Solutions

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Apheresis Expertise in a Apheresis Expertise in a Quality Systems FrameworkQuality 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 NetworkApheresis Collection Network

The HemaCare Advantage•Established network of collection centers•Rapidly add new centers as needed•Standardized protocols and procedures across all sites • 24/7/365 support from clinical,

logistics, regulatory, and training experts

• Single point of contact

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Logistics ManagementLogistics Management

The HemaCare Advantage•Complete HemaCare oversight of all controlled room temperature to cold chain logistics•Oversight of samples (apheresis materials) from collection to final destination•HemaCare owned, maintained, and validated shipping containers (shippers)•“Best in class” biopreservation media

– Cryostor® CS10

– Hypothermosol® FRS

•Transport of global samples to US

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Controlled Room Temperature to Controlled Room Temperature to Cold Chain LogisticsCold Chain Logistics

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HemaCare owned, maintained, and validated room temperature, cold, and cryopreservation containers for all sample types

1.Cryopreserved materials

– LN2 transport dewars

2.Frozen materials (-800 Celsius)

– Proprietary containers

3.Fresh materials (2-80 or 20-240 Celsius)

– Proprietary containers

Cryopreservation SupportCryopreservation Support

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Short Term

Support cryopreservation

consistency during process development

Medium Term

Support validation of

cryopreservation process for

clinical trials

Long Term(Commercialization)

Provide a centralized

solution for ALL cryopreservation

of patient apheresis collection material

“Cellular Therapy Solutions”

In Conclusion…In Conclusion…• Collecting blood-based cellular products in a manner that minimizes variability

brings a higher degree of reproducibility to the research project or manufacturing effort

• Quality-based controls such as standardized SOPs, staff training and competency assessments, equipment management, and monitoring of quality indicators reduce this variability

• Relationships with other best in class organizations allows for consistent product development and collaborations focused in improving the cell manufacturing process.

• Use of cGMP, serum-free, protein-free biopreservation media such as HypoThermosol and CryoStor shows great promise to enable worldwide shipment of fresh or frozen cellular products, extending shelf-life of cell therapy products.

• HemaCare has the knowledge, experience, and capability to provide total apheresis, room temperature to cold chain, and cryopreservation and storage solution

• Complete in-house control of the entire process from collection to final destination

• Just-in-time delivery of viable, high quality apheresis materials to any location globally

• The only supplier with true, validated, global reach

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Thank You!Thank You!

Visit us at Visit us at www.hemacare.comwww.hemacare.com

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