Cytiva_APR21_EarlyProcessDevDecisions - 20

Cell Therapy Manufacturing Tries " Building the Plane While Flying It "

But for cell therapy firms, there are often other

But the situation is changing thanks to tech-

factors at play. For example, according to

nology and process innovation. " Better capitalized

Davies, the granting of early approvals is a major

cell therapy companies are now commissioning

outsourcing driver.

significant in-house manufacturing capability, "

" Partly due to the rapid developmental trajec-

Davies points out. " And some are hedging by

tory of many recent cell therapy approvals, many

utilizing this in combination with outsource

companies have simply not had time, money, or

options. "

expertise to develop in-sourced manufacturing
solutions, " he explains. " A small number of legacy


CMOs, who have been in the field since before its

Iovance Biotherapeutics is an example of a firm

recent tailwinds, have performed a large amount

that maintains in-house cell therapy manufac-

of manufacturing. "

turing capacity. In this case, the firm produces
a range of tumor-infiltrating lymphocyte (TIL)

Automation is, in fact,
becoming more common
in process development and
analytical method

" TIL therapy is a cell therapy treatment that
uses a patient's own cancer-fighting immune cells
to attack solid tumors, " says Arvind Natarajan,
PhD, Iovance's vice president of CMC. " TILs
are extracted from tumor tissue. Once TILs are

Burger also acknowledges the pivotal role that

expanded and infused back into the patient, they

contractors play. " The majority of cell therapy

should be able to seek and enter a tumor, where

manufacturing is outsourced to contract manu-

they recognize, attack, and destroy the tumor. "

facturers at present, " he says. " This is especially

To manufacture TILs, Iovance uses a process

true early in development. There are several

known as Gen 2. The process begins, Natarajan

full-service cell therapy contract manufacturers

points out, when biopsies are removed from

like Lonza, Miltenyi Biotec, Cognate BioServices,

patient tumors. Next, the biopsies are shipped

Oxford Biomedica, Paragon Gene Therapy [part of

to a manufacturing facility, where the TILs are

Catalent Biologics], KBI Biopharma, MaSTherCell,

extracted and expanded. Finally, the TILs are

Brammer Bio [part of Thermo Fisher Scientific],

returned to the patient.

Cobra Biologics, and Hitachi Chemical Advanced
Therapeutics Solutions-to name just a few. "

20 |

" Our rapid Gen 2 manufacturing process allows
us to complete the entire TIL manufacturing process


Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

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