Manufacturing With Insight

PCT: The Cell Therapy

Industry’s Partner

October 2016

Our Vision

A world in which transformative cell-based therapeutics are accessible to all.

Our Mission

To provide our clients with high quality, scalable, innovative,

reliable, and cost-efficient manufacturing platforms and services

to advance commercialization of cellular therapies.

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Unprecedented cell therapy expertise

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Leading the evolving cell therapy industry

Early

Development

Trailblazing

Manufacturing

Business

Expansion

Innovation and

Commercialization

1990 - 2000 2001 - 2010 2011 - 2015 2016 forward

Research by Robert

Preti, PhD leads to

Dermagraft, early tissue

product

PCT co-founded by

Robert Preti, PhD,

Hackensack UMC stem

cell laboratory acquired

George S. Goldberger

joins as Chief Business

and Financial Officer to

oversee business

operations

Dendreon contract

secured to manufacture

Provenge

Dendreon’s facility in

CA acquired and NJ

facility opened

Dendreon submits

Provenge BLA based

on eight years of PCT

manufacturing

Brian Hampson (now

PCT VP) develops

Aastrom Replicell

System

Multiple client

partnerships

established; many still

active today

PCT acquired by

Caladrius

Multiple client

partnerships

established; many still

active today

PCT’s Center

for Innovation and

Engineering launched

Global collaboration

with Hitachi Chemical

Co. launched

Seamless 60%

cleanroom capacity

expansion underway at

NJ facility

Planned establishment

of new commercial

facility in US to meet

demand

Asian and European

manufacturing launch

announced

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Creating a global commercial enterprise

with deep engineering expertise

Allendale, NJMountain View, CA

March 2016 Hitachi

purchased 19.9% equity

stake in PCT US operation

Intention to

pursue PCT/Hitachi

European joint venture

Hitachi licensed PCT

technology and know-how

to create Hitachi-PCT

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Unparalleled track record of exclusive

focus on cell and cell-based gene therapy

17+ year track record of excellence in:

cGMP InfrastructureTo deliver operational excellence

cGMP Manufacturing

Technology Transfer

Global Logistics and Storage

Manufacturing and

Technology DevelopmentTo define and execute “future state”

cell therapy processes

The Center for

Innovation and Engineering

Consulting

Analytical Development

Process Development

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Extensive expertise in multiple

therapeutic applications and cell types

Immunotherapy

Dendritic cells

T cells (CAR, TCR, Treg)

Tumor cells

Natural killer cells

Donor lymphocyte infusion

Macrophages

B cells

Neuro/endocrine

Neural stem cells

Porcine islets

Stem cells

CD34+ gene edited cells

Hematopoietic progenitor cells

Connective/dermal/

stromal tissue cells

Mesenchymal stromal cells

Fibroblasts

Keratinocytes

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Unprecedented results in meeting client milestones

and a patient-focused mindset

Products

Manufactured

more than

20,000

Technology

Transfers

more than

30

Patients

Treated

more than

6,000

Clients

Served

more than

100

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Partner-of-choice for a who’s who of the industry

range from start-ups to large pharma

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Providing complete development and manufacturing

solutions for long-term success

STRATEGIC

MANUFACTURING

ASSESSMENT

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Provide Systematic Roadmap

MANUFACTURING

DEVELOPMENT

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Navigate Streamlined Process

CLINICAL &

COMMERCIAL

MANUFACTURING

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CELL THERAPY

PRODUCT DEFINITION

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Develop Trusted Partnership

Deliver Operational Excellence

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An understanding of the entire

“needle-to-needle” process

Through ProcessingFrom Collection To Infusion

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Delivering the capacity you need

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Bicoastal facilities offer flexibility and mitigate risk

PCT East PCT West

Location Allendale, NJ Mountain View, CA

Airport proximity EWR, JFK, LGA SFO, SJC, OAK

Facility capacity 30,000 sq. ft. 25,000 sq. ft.

ISO 7 cleanrooms 3* 7

EU grade B/ISO 6 cleanrooms 5* -

Quality control Extensive Extensive

Manufacturing, process

and analytical development Extensive Extensive

Cryostorage facility Yes Yes

*by second quarter 2017- upgrade in progress

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Offering capacity utilization models to

match your development phase

Shared Capacity Dedicated Capacity

Appropriate client Low volume/early phase High volume/late phase or commercial

AdvantagesPay for the capacity you need

regardless of enrollment rate

Project cost accurately within

a range of enrollment rates

Service feesBy manufacturing

process run

By dedicated cleanroom

and staff over time period

StaffingNon-dedicated;

trained in your process

Dedicated; trained and develop

expertise in your process

cGMP infrastructure Eliminate capital investment Reduce capital investment

Process segregationControlled by procedures

and line clearanceRisk mitigated

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Addressing the unique challenges

of cell therapy manufacturing

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Focusing on deliverability and its key drivers

from the earliest stages of development

Development by Design

At our Center for Innovation and Engineering,

we explore and evaluate technologies to enable commercial success

Cost of

GoodsSustainabilityRobustness Scalability Quality

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These drivers must be designed into products early in development

Guide your process development efforts

with a Strategic Manufacturing Assessment

Structured, disciplined, independent review of

client process and/or technology by our experts

- Strategic optimization recommendations

- Suitability/gap assessment for tech transfer and clinical readiness

- Technology landscape analysis to guide decision making

- 6 - 8 week engagement, ~$50,000 cost

Guided by:

QbD (Quality by Design), DbD (Development by Design), QTPP (Quality Target Product Profile)

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Case Study: Major biotech leveraging PCT’s experience

to optimize and manufacture their cell-based gene therapy

STRATEGIC MANUFACTURING

ASSESSMENT

MANUFACTURING

DEVELOPMENT

CLINICAL

MANUFACTURING

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Developing the cell therapy factory of the future

Highly mitigated cost impact of idle capacity

Concurrent adjacent processing of patient lots

Highly mitigated risk of human error

Manufacturing in controlled, non-classified (CNC) spaces

Minimal set of unit operations to execute process

Very low failure-to-deliver-therapy rate

Robust, secure supply chain

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Ongoing initiative of the Center for Innovation and Engineering

World-renowned brand,

driving the direction of the industry

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World-renowned brand, leading cell therapy discourse

PCT-authored

publications

Conference

presentations and panels

By industry organizations

and scientific media outlets

50+ 25+ Highly Regarded

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Driving cell therapy technology forward

Developing closed and automated

cell therapy manufacturing technology

Actively engaged by

technology developers

to evaluate new devices

Moving clients to

automated solutions and

end-to-end closed systems

The Center for

Innovation and

Engineering

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Manufacturing With Insight

Contact

PCT East

4 Pearl Court, Suite C

Allendale, NJ 07401

(201) 883-5300

PCT West

291 Bernardo Avenue

Mountain View, CA 94043

(650) 964-6744

Caladrius Biosciences, Inc.

106 Allen Road, Fourth Floor

Basking Ridge, NJ 07920

(949) 725-1750

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