Cytiva_APR21_EarlyProcessDevDecisions - 35

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Cell and Gene Therapy Sector
Needs to Automate
By Gareth John Macdonald

C

ell and gene therapy firms are not ready

These needs include being able to vary

to fully embrace artificial intelligence

output, he continues, adding that it is harder

(AI) says an official at the US subsidiary

to predict approval timelines and commercial

of Hitachi Chemical, who thinks developers and

demand for cell therapies than for other biophar-

manufacturers must learn to automate produc-

maceuticals. " We have built out our infrastruc-

tion first. The Japanese conglomerate cemented

ture in a modular manner so that we can build

its presence in the cell therapy contract manu-

specific capacity to meet commercial customer

facturing space in January with the opening of

needs as we get a clearer picture of the forecasts

a facility in Allendale, NJ. The facility, which is

and needs. "

operated by Hitachi Chemical Advanced Thera-

Data exchange is also built into the plant's

peutics Solutions (HCATS), is the first designed

design. " Manufacturing Execution Systems and

" to meet the unique needs of commercial

LIMS systems are being implemented to move

cell and gene therapy products, " according to

from paper systems to electronic and enable

Thomas Heathman, PhD, HCATS' business leader

seamless data flow throughout the facility, " he

in North America.

points out.

Cytiva: What we do
We're helping life science researchers and biopharmaceutical
manufacturers evolve how new therapies and precision
medicines are discovered, made, and used. Our goal is to aid
in providing the right treatment to
the right patient in a cost-effective,
Watch the
efficient, and safe way - improving
video
the quality of life for every person.

GENengnews.com

| 35


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