(MENAFN- ProactiveInvestors - Australia) NuSep (ASX: NSP) has completed a lease with Singapore-based Ascendas group for a cGMP facility in Singapore, where NuSep plans to produce around 150,000 litres of human therapeutic products per year.
The company's subsidiary PrIME Biologics, will lease about 2,000 square metres of cGMP production space and an additional 3,000 square metres for the ancillary equipment and air handling services required to operate the facility.
The facility was previously owned by Luye Pharma Group and traded under the name of A-Bio.
PrIME Biologics has reactivated the facility and is now preparing an application to the Health Sciences Authority (HSA) of Singapore for a cGMP license to manufacture human therapeutic plasma products.
Earlier this week, NuSep announced the subsidiary had successfully completed three trial production runs of Human Albumin, therapeutic grade human plasma, in Singapore.
Importantly, the production run helps the company prepare for the cGMP certification required to produce the first batch of therapeutic plasma products for the clinical trials anticipated to start later this year.
PrIME will undertake further replications of this initial trial run before preparing to complete further trial production fractionation runs of Human IVIG.
Ultimately, PrIME Biologics intends to undertake production of Albumin, IVIG, FVIII and FIX from human plasma in its Singapore cGMP facility.
NuSep is planning to spin out its therapeutic plasma fractionation business, PrIME Biologics, to realise the asset's S$60 million (A$46 million) value.
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.