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news.Isis Pharmaceuticals has received Good Manufacturing Practices (GMP) certification to its manufacturing facility located in Carlsbad, California, US, from the EMA for the production to support Kynamro commercial launch.
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The approval of the manufacturing facility allows Isis to supply Genzyme with Kynamro drug substance to support its commercial launch in Europe.
Isis chief operating officer, chief financial officer and secretary Lynne Parshall said the company has reduced the cost of manufacturing and increased its capacity, which will support the numerous potential commercial products that could be coming out of its pipeline in the near-term.
"The European regulatory approval of our manufacturing facility is an important milestone for Isis and a validation of our high standards and excellence in manufacturing antisense drugs," Parshall added.
Isis is a manufacturer of oligonucleotide drugs and discovers proprietary inventions that support different aspects of oligonucleotide drug manufacturing, including improving manufacturing efficiency and capacity.