NEW YORK, July 24 (Reuters) - Big pharmaceutical

companies that make personalized blood cancer treatments are

working to cut the manufacturing turnaround time by as much as

half in coming years, as they try to deliver them sooner in a

patient's disease course.

These treatments known as CAR-T therapies are used for the

sickest patients for whom standard treatments have failed. They

involve removing a patient's T cells - a key component of the

immune system - after which they are re-engineered to recognize

and attack malignant cells once they are re-infused.

Gilead Sciences ( GILD ), Novartis, Johnson &

Johnson ( JNJ ), and Bristol Myers Squibb ( BMY ) have made

billions from their treatments, which can extend lives by months

or years for patients with aggressive advanced cancers.

Trimming days or weeks from the time it currently takes

between removing and reintroducing the cells to a patient could

open the treatment to those who otherwise would become too sick

during the process, according to three doctors, the companies

and analysts.

Prices for the one-time treatment range from $400,000 to

nearly $600,000, and analysts estimate they currently have

profit margins of about 50%, so expanding the patient population

is not insignificant.

Oppenheimer & Co analyst Hartaj Singh said only around 1 in

5 eligible patients receive CAR-T treatments.

"It's complex manufacturing using the patient's own cells,

but because some of the responses reported are just so long and

durable, physicians will go to it," Singh said. "It's the

biggest gun out there."

Time to treatment, which was as long as 37 days when the

first CAR-T therapy was launched in 2017 by Novartis, are now

down to 14 days at Gilead. Improvements in automation and

regulatory adjustments could help companies further trim that

time.

Singh said physicians suggested to him that a one-week

turnaround could expand these treatments to 2 or 3 out of 5

eligible patients.

Improvements in manufacturing time could be a competitive

edge when therapies are approved for the same cancer or

population and directly compete, and could give companies a leg

up on more quickly available treatments such as antibodies or

antibody drug conjugates, he added.

To make the treatments, a patient's T cells are isolated,

frozen and shipped to manufacturers. Once received, the cells

are purified, modified and expanded to large enough numbers to

treat the patient. They then go through quality control

processes before being re-frozen and shipped back for infusion.

Gilead is testing new technology it hopes can cut two days

from the manufacturing process by using healthier and more

potent younger cells.

The company is also looking to fully automate some parts of

manufacturing that are now semi-automated and gain regulatory

approval to shorten the quality control time.

Novartis is aiming for 10 days or less in the U.S. for its

next generation of treatments through its rapid manufacturing

platform T-Charge. Its treatment, Kymriah, currently takes 3 to

4 weeks with a target of 22 days.

Novartis said the T-Charge system would shorten the

manufacturing time because it allows for the engineered cells to

multiply within the patient, reducing the need for extended cell

expansion before infusion.

'EVERY DAY MATTERS'

Dr. Chijioke Nze of MD Anderson Cancer Center in Houston

said a manufacturing time of a week would be ideal.

Frailer patients can develop kidney or liver dysfunction

while they wait for their therapy to be manufactured or may

become too weak to be able to successfully undergo treatment,

Nze said. He has prescribed Gilead's Yescarta and Tecartus as

well as Bristol Myers' Breyanzi.

"The patient population that needs CAR-T cell therapies

generally have the more aggressive of an already aggressive

disease," he said.

Analysts and drugmakers say using CAR-T drugs earlier before

doctors first prescribe multiple other treatments that fail to

help patients would also expand use. J&J's Carvykti, for

example, was approved in April for patients who did not benefit

from just one other treatment for multiple myeloma.

Some CAR-T approvals require patients to receive three or

four other treatments to fail before using the therapy.

Increasing the number of hospitals and health centers

offering the treatments also will make it feasible for more

patients, they said.

Since 2017, over 42,000 people globally have received CAR-T

treatments. Six are approved in the U.S. for the treatment of

blood cancers, including lymphomas and some forms of leukemia.

Lynelle Hoch, who leads Bristol Myers Squibb's ( BMY ) cell therapy

business, said its current focus is on increasing manufacturing

capacity. Still, it said its time to produce the treatments is

trending lower and will be helped by its collaboration with

Cellares, a development and manufacturing organization with a

fully automated cell therapy production platform.

J&J in a statement said it doubled its CAR-T manufacturing

capacity last year and is striving to double it again in 2024.

It said it is working to further reduce treatment times.

Cindy Perettie, an executive at Gilead's Kite cell therapy

unit, said in an interview that lymphoma patients who have

already tried two treatments generally only have months to

survive and need to get treated as quickly as possible.

"Every day matters for these patients."