News and Announcements
PrIME Completes First Three Trial Production Runs of Albumin in Singapore GMP Facility
- Published January 02, 2013 3:32AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Sydney, Australia 8th January 2013-NuSep (ASX:NSP) wishes to advise the market that staff at its Singapore subsidiary PrIME Biologics has successfully completed three trial production runs of Human Albumin using its pilot production unit in Singapore current Good Manufacturing Practice (cGMP) production facility. These trial production runs were completed in a cGMP environment using human plasma kindly provided by the Health Sciences Authority (HSA) of Singapore in association with Defense Medical and Environmental Research Institute. Scientists from the HAS and the Defense Science Organization (DSO) viewed the 3rd Human Albumin PrIME production run while visiting PrIME Biologics cGMP production facility in Singapore. A report on these 3 trial production runs has been submitted to the HSA.
These initial trial run of Human Albumin represent a major milestone as it is the first time that 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, the PrIME Biologics personnel have 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. This also validates the robustness of the PrIME process, an important feature as this process will be replicated throughout Asia.
——-
To view the full article, please click the link below.