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Isis Manufacturing Site Gains EMA Approval

Will supply Genzyme with Kynamro drug substance

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Isis Pharmaceuticals has successfully completed a preapproval inspection of its manufacturing facility in Carlsbad, CA. The EMA reviewed Isis’ manufacturing facility, processes, and GMP quality systems. The approval allows Isis to supply Genzyme with Kynamro drug substance to support commercial launch in Europe.   “Isis is the leading antisense drug discovery company with a broad pipeline of more than two dozen drugs in development. As we have increased the efficiency of our drug dis...

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