Thursday, 20 June 2019

Biostar, RNL Bio make stem cell lab FDA compliant

22 November 2012 | Regulatory | By BioSpectrum Bureau

Human Biostar and RNL Bio overhaul stem cell lab to make it FDA compliant

Human Biostar and RNL Bio overhaul stem cell lab to make it FDA compliant

Singapore: US-based Human Biostar and South Korea-based RNL Bio have completed the revision and supplementation of the formers stem cell laboratory (GTP Center I) to be compliant with FDA regulation.

Human Biostar is engaged in the contract service for stem cell banking, producing and supplying to CellTex. The construction of its first GTP Center was initially finished on October 11, 2011, with processing capacity of up to 3,000 customers per annum.

It has been working on complementing and satisfying the FDA's comments and recommendations regarding compartmentalization, efficient management systems and additional forms and documentation. During revision, the lab was temporarily closed but it is now open and is back to its normal operations. Customers can now place a service order and enjoy the state-of-the-art banking service with the stem cell center.

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