Cytiva_APR21_EarlyProcessDevDecisions - 21

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

in 22 days, " Natarajan asserts. " The cells are cryopre-

Iovance is investing $75 million over three

served at the end of the manufacturing process,

years to build a custom commercial manufac-

allowing flexibility in the timing of the infusion based

turing facility in Philadelphia. According to

on patient requirements. "

Natarajan, the facility has a modular design to

" The original Iovance process is licensed from
the National Cancer Institute, " he notes. " We
have since made significant improvements in
the process. The current Gen 2 process is propri-

allow for scalability of production depending on
necessary volume.

CELL THERAPY PRODUCTION REGULATIONS

etary, so the specific process and applications

Besides technological change, the cell therapy

are protected by the company's intellectual

industry is experiencing regulatory change.

property rights.

According to Davies, regulators are being forced

KEY: CELL THERAPY CAPACITY Some cell therapies make use of tumor-infiltrating lymphocytes (TILs), which may be removed from a
donor's tumor, treated in the laboratory, and reintroduced to the donor's tumor. One company that processes TILs is Iovance Biotherapeutics. The company's technology is designed to target patient-specific antigens, enhance T-cell number and potency, and control the
tumor microenvironment to reduce immune suppression.

GENengnews.com

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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