Cytiva_APR21_EarlyProcessDevDecisions - 17

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Although cell therapy firms are starting to build in-house manufacturing capabilities, most of these firms still rely on contract manufacturers. For example, some firms outsource their manufacturing to Lonza, which maintains a cell processing facility in Walkersville, MD.
The facility's manufacturing suites range in size from 275 to 1,000 square feet and may be configured to meet customers' needs. Suites
can meet U.S. or European regulatory standards.

come with potential downsides. For example,

licensure on complex products which have spent

early approvals may give manufacturers little

a relatively short amount of time in pharmaceu-

time to hone their production processes. For

tical development. Approvals out of, effectively,

hard-to-make products such as cell therapies,

Phase II trials are becoming likely for products

commencing large-scale manufacturing sooner

with even less than Phase II-grade chemistry,

rather than later can keep production costs high.

manufacturing, and control (CMC) readiness. "

HIGH COST OF GOODS

According to Davies, underdeveloped processes
increase the cost of goods as a result of the

" In recent years, cell therapy approvals have been

manual steps and the bespoke technologies used.

driven by a tailwind of terrific clinical data, " says

Underdeveloped cell therapy processes also lack

Anthony Davies, PhD, founder and CEO of Dark

scalability, observes Fabio Fachin, PhD, head of cell

Horse Consulting. " This has thrust commercial

therapy engineering and automation, Takeda.

GENengnews.com

| 17


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Cytiva_APR21_EarlyProcessDevDecisions

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