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MEMPHASYS LIMITED. — Capital/Financing Update 2012
Oct 2, 2012
65314_rns_2012-10-02_9b1c8ed5-c419-4785-91fd-a886960ac7db.pdf
Capital/Financing Update
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FOR IMMEDIATE RELEASE
NuSep achieves Critical Milestone with Installation of PrIME unit in Singapore
Sydney, Australia 3[rd] October 2012 - NuSep (ASX:NSP) wishes to advise the market that it has installed a PrIME unit in its Singapore cGMP facility thus achieving a critical milestone. The unit was shipped from Sydney last week and has now been formally installed in the Singapore facility.
The installation of the pilot PrIME unit allows PrIME Biologics to test run the manufacture of therapeutic plasma proteins paving the way for the delivery of the 250L therapeutic production unit in the next six months.
The PrIME unit that has been installed in Singapore is a 10L cGMP compliant pilot scale unit. This unit is capable of processing 10L batches of plasma in compliance with cGMP and is a single unit of the disposable cartridge system to be installed in Singapore. PrIME will be manufacturing therapeutic plasma products in 250L batches. The 250L therapeutic production unit will consist of 25 single disposable cartridges operated as a single unit. As per the timeline below, PrIME anticipates receiving cGMP approval from the Singapore HSA in 9-12 months’ time.
Based on the 250L batch size the PrIME facility in Singapore will be able to process up to 150,000L of therapeutic plasma products in a full year.
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PrIME unit in Singapore
Postal Address P.O. Box 823 Lane Cove NSW 1595
Contact Details Telephone +61 2 8415 7300 Facsimile +61 2 8415 7399
Email [email protected] Web www.nusep.com ABN 33 120 047 556
NuSep Holdings Ltd 324 Burns Bay Rd Lane Cove NSW 2066
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Once PrIME has received this cGMP approval it will manufacture the therapeutic plasma products for its Singapore clinical trials. PrIME will start processing the currently unprocessable plasma ( CUP ) material for countries such as India once the clinical trial product has been manufactured. This CUP production will produce PrIME’s first sales.
Below is the expected timeline for PrIME Biologics therapeutic plasma products.
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ENDS
For more information please contact:
Contact: Swapna Keskar Company Secretary +61 2 8415 7300 [email protected]
About NuSep
NuSep (ASX: NSP) is a publicly listed life sciences company that sells products into the global BioSeparations market. NuSep recently acquired BioInquire which developed the ProteoIQ software enabling NuSep to offer a total Proteomics solution from Fraction to Function . The company has offices in both Sydney Australia and Atlanta, USA.
With a 30 year heritage in biological separations, NuSep has forged a world class reputation for its innovative yet simple biological separation techniques including the world’s first IVF sperm separation device. In short NuSep has redefined the BioSeparations market through innovation and simplification.
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NuSep’s world renowned research team has developed an extensive portfolio of patented products. In all, NuSep currently manufactures, distributes and sells 55 products to customers in the USA, Europe, Asia and Australia.
NuSep Products:
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- Gels – NuSep manufactures and sells precast gels including the innovative nUView Gels, which can be visualised 2 minutes after use.
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- Separation Instruments – NuSep has developed two unique biological separation instruments. The ProteomeSep was released in 2009 and can separate biological samples into 8 fractions for use in the proteomic market. The SpermSep separates sperm for fertility treatments such as IVF.
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- Proteomics Software – NuSep offers the unique ProteoIQ software for the analysis of complex mass spec samples. This software is also designed to identify bio markers.
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- Biological Products – NuSep supplies research grade biological products manufactured using its unique separation technologies. These products include human IgG and Albumin .
For more information about NuSep please visit the company’s website www.NuSep.com
About PrIME Biologics Pte Ltd
PrIME Biologics is a Singapore based biotech company that has developed a disposable procedure for the processing of plasma proteins. PrIME Biologics is a subsidiary of NuSep Holdings Limited (ASX: NSP). PrIME Biologics process is based on the Pr eparative I solation by M embrane E lectrophoresis (PrIME) technology developed by NuSep. PrIME provides disposable modular processing that is ‘electronically’ driven membrane fractionation.
The PrIME process increases product yields to over 90% relative to the existing process 50% while increasing product safety. The PrIME has been shown to remove virus, bacteria, endotoxins and prions which cause ‘Mad Cow Disease’. Further, PrIME Biologics process can produce multiple plasma products in hours compared to days, which is required by the current manufacturers.
The initial application for the PrIME process will be the Currently Unprocessable Plasma which represents approximately 50% of all the plasma collected in many Asian countries.