(MENAFN- ProactiveInvestors - Australia) NuSep (ASX: NSP) has 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 Good Manufacturing Practise (cGMP) certification required to produce the first batch of therapeutic plasma products for the clinical trials anticipated to start later this year.
The initial trial runs, which were undertaken by Singapore subsidiary PrIME Biologics, represent a major milestone as it is the first time the PrIME process has ever been operated in a cGMP facility.
It is also the first trial production run using the pilot scale PrIME plant since it was transported to Singapore.
Since the pilot scale PrIME unit was shipped to Singapore in October 2012, PrIME Biologics has been restarting the cGMP facility which had not been active for several years.
The pilot scale PrIME unit was activated in early December 2012 and was operational from initial start-up.
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.
PrIME Biologics spinout
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.
The move allows NuSep to focus on the development of new PrIME Technology applications while also creating two new highly profitable revenue streams for the company.
PrIME Biologics is using NuSep's PrIME Technology in its therapeutic plasma manufacturing process and is concentrating on opening up the Asian therapeutic plasma market, particularly the untapped Currently Unprocessable Plasma (CUP) market.
By comparison, NuSep's strategy is to develop applications of the PrIME Technology which will generate sales of both equipment and long term supply contracts of the consumables.
By spinning out PrIME Biologics, NuSep can concentrate on commercialising other applications of the PrIME Technology including IVF sperm separation, recombinant proteins and renal dialysis.
NuSep will seek shareholder approval to spinout PrIME Biologics once it has received the necessary approvals from ASIC and the ASX.
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