Pharma Focus Asia

Novo Nordisk to Establish Manufacturing Site in California

Introduction:

Novo Nordisk announced the establishment of a manufacturing site in Fremont, California, US to develop and produce stem cell-based therapies.

Features:

The site will develop stem-cell-based therapies within type 1 diabetes and other serious chronic diseases.

The announcement follows the signing of a long-term lease on a Good Manufacturing Practice (GMP) facility, previously operated by Asterias Biotherapeutics.

The manufacturing site will fulfill the supply of stem cell-based therapies for Novo Nordisk's clinical trial programmes.

It will be operational in 2019 providing stem cell-based therapies for a range of serious chronic diseases.

The facility will be capable to the large-scale supply of therapies.

Novo Nordisk has secured a two-year non-exclusive license on Asterias' intellectual property relating to stem cell manufacturing technology.

Novo Nordisk will sublease laboratory, manufacturing and office space within the facility back to Asterias until the end of 2021, to facilitate collaboration between the two parties.

The establishment of the production site enables the generation of GMP compliant human Embryonic Stem Cell (hESC) lines in addition to the rights to develop these into future regenerative medicine therapies.

The partners are deriving cell lines that are defining a new quality standard in the production of stem cell-based therapies.

The new production facility will enable the future expansion of Novo Nordisk's stem cell research portfolio into the clinic.

Specifications:

NameNovo Nordisk
TypeConstruction
Parties InvolvedNovo Nordisk and GMP
ScheduleScheduled to be operational in 2019
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