Caladrius, PCT and TrakCel to Drive Cell Therapy Manufacturing Excellence

CARDIFF, Wales–(BUSINESS WIRE)–TrakCel Ltd. today announced a collaboration agreement with Caladrius
Biosciences, Inc. (Nasdaq:CLBS)
and its subsidiary PCT, a Caladrius Company (PCT) to implement its cell
therapy process management and supply chain integration technology.

TrakCel’s technology integrates and automates the entire cell therapy
process end-to-end while providing real-time audit logs and
chain-of-custody records to stakeholders. It further reduces the
implementation risks associated with disparate, paper-based systems as
TrakCel technology accelerates scale up and scale out of cell therapy
processes through immediate access to data for validation and regulatory

Dr. Robert A. Preti, President of PCT and Senior Vice President,
Development and Technical Operations and Chief Technology Officer of
Caladrius Biosciences said: “We’re
committed to providing our clients with industry-leading cell therapy
manufacturing founded on exceptional facilities, processes and people.
TrakCel’s innovative technology holds significant potential and we are
looking forward to realizing its benefits in the near future.”

PCT and TrakCel will undertake in Q4 2015 a design specification stage
prior to implementing a customized cell therapy process management
solution based on TrakCel’s technology.

“PCT has an unparalleled pedigree in contract manufacturing with over 16
years’ industry experience and over 30,000 products created,” said Kevin
Smith, Director, TrakCel. “We’re looking forward to collaborating with
PCT as it strives to provide innovative solutions to its clients.”

PCT has full-scale cGMP/GLP operations in New Jersey and California,
thousands of square feet of Class 10,000 clean rooms, and full QA/QC
support. The company has had over 100 clients whose products have
treated over 6,000 patients.

The collaboration agreement supports UK-based TrakCel’s strategy to
expand into the US market, and comes ahead of the company’s plan to
establish US offices in 2015.

  • ENDS –

Notes to Editors

About TrakCel

TrakCel’s cell therapy process management solution improves clinical
study efficacy and accelerates product scale-up/scale-out by
implementing communications technology to integrate the supply chain
from end-to-end. The technology provides interactive instructions to
professionals within the cell therapy supply chain and gives
stakeholders on-demand visibility of procedural results and
chain-of-custody data for immediate traceability, validation and
compliance audits. Founded in 2012, TrakCel technology has been adopted
by GlaxoSmithKline and other leaders in the cell therapy industry.
TrakCel is based in Cardiff, Wales, UK.

TrakCel Ltd.

11 Raleigh Walk

Brigantine Place

Cardiff, UK, CF10 4LN

About Caladrius Biosciences

Caladrius Biosciences, Inc. is among the first of a new breed of
immunotherapy companies with proven expertise and unique experience in
cell process optimization, development, and manufacturing. Caladrius is
a cell therapy leader with late-stage clinical programs based on a
proprietary platform technology for immuno-oncology, as well as
additional platform technologies for ischemic repair and
immunomodulation, and capabilities that support other cell therapy
developers. This integrated approach supports the industry in bringing
significant life-improving medical treatments to market.


Iain Wood, Public Relations
+44 (0)2920 483729
Biosciences, Inc.

Eric Powers
Manager of Communications
and Marketing
Phone: +1-212-584-4173

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