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news.Lonza and Celladon have signed a process transfer and GMP manufacturing agreement for Mydicar, a genetically targeted enzyme replacement therapy.
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Mydicar, intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility, is delivered directly to the heart in a single dose during a routine outpatient cardiac catheterization procedure, similar to an angiogram.
Lonza viral-based therapeutics head David Enloe said, "In particular, this is an exciting project for Lonza in that we will be producing materials for Celladon beginning at the 1,000 liter scale and likely expanding to 2,000 liters, which our recently completed and validated GMP suite was specifically designed to support."
As per the agreement, Lonza will manufacture cGMP-grade Mydicar (AAV1/SERCA2a) for use in future advanced heart failure clinical trials.
Celladon intends to commence commercial scale manufacture of Mydicar, Celladon and Lonza have agreed to discuss a commercial scale supply agreement.
Celladon president and CEO Krisztina Zsebo said, "Lonza’s large scale viral manufacturing expertise will greatly complement and support our future development and commercialization efforts for MYDICAR."