1. Manufacturing With Insight
PCT: The Cell Therapy
Industry’s Partner
October 2016

2. 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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3. Unprecedented cell therapy expertise
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4. 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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5. 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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6. Unparalleled track record of exclusive
focus on cell and cell-based gene therapy
17+ year track record of excellence in:
cGMP Infrastructure
To deliver operational excellence
cGMP Manufacturing
Technology Transfer
Global Logistics and Storage
Manufacturing and
Technology Development
To define and execute “future state”
cell therapy processes
The Center for
Innovation and Engineering
Consulting
Analytical Development
Process Development
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7. 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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8. 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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9. Partner-of-choice for a who’s who of the industry
range from start-ups to large pharma
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10. Providing complete development and manufacturing
solutions for long-term success
STRATEGIC
MANUFACTURING
ASSESSMENT
02
Provide Systematic Roadmap
MANUFACTURING
DEVELOPMENT
03
Navigate Streamlined Process
CLINICAL &
COMMERCIAL
MANUFACTURING
04
CELL THERAPY
PRODUCT DEFINITION
01
Develop Trusted Partnership
Deliver Operational Excellence
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11. An understanding of the entire
“needle-to-needle” process
Through ProcessingFrom Collection To Infusion
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12. Delivering the capacity you need
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13. 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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14. 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
Advantages
Pay for the capacity you need
regardless of enrollment rate
Project cost accurately within
a range of enrollment rates
Service fees
By manufacturing
process run
By dedicated cleanroom
and staff over time period
Staffing
Non-dedicated;
trained in your process
Dedicated; trained and develop
expertise in your process
cGMP infrastructure Eliminate capital investment Reduce capital investment
Process segregation
Controlled by procedures
and line clearance
Risk mitigated
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Addressing the unique challenges
of cell therapy manufacturing
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16. 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
Goods
SustainabilityRobustness Scalability Quality
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These drivers must be designed into products early in development

17. 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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18. 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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19. 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

20. World-renowned brand,
driving the direction of the industry
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21. 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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22. 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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23. 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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