Product Manufacture Begins

04-Oct-2013 Sienna has commenced regulatory compliant manufacturing of an analyte specific reagent that binds to telomerase. The manufacturing, performed under Good Manufacturing Practice (GMP), has been outsourced to a leading US contract manufacturing organisation with extensive experience in the manufacturing of diagnostic reagents. Although the manufacturing process has been outsourced, Sienna retains the status of “Legal Manufacturer”, an important label in commercialisation and value creation. 

In support of these US activities, Sienna has contracted two expert US-based consultants to advise Sienna on all regulatory, quality management and manufacturing matters. Notwithstanding some remaining technological risks, the manufacturing process is expected to conclude in the first half of 2014.


 
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