Lonza to manufacture Mydicar for Celladon
The firms have signed a process transfer and GMP manufacturing agreement
Swiss industry supplier Lonza and cardiovascular disease specialist Celladon Corporation have signed a process transfer and GMP manufacturing agreement under which Lonza will manufacture cGMP-grade Mydicar for use in future clinical trials. If Celladon, a biopharmaceutical firm based in La Jolla, CA, US, later decides to start commercial-scale manufacture of the heart failure treatment the firms will negotiate a supply agreement.
David Enloe, Lonza’s head of Viral-based therapeutics, said: ‘We will be producing materials for Celladon beginning at the 1,000 litre scale and likely expanding to 2,000 litres, which our recently completed and validated GMP suite was specifically designed to support.’
Lonza will provide process development, product quality testing, product storage, and distribution.
‘This is an important milestone in the Mydicar development programme,’ said Krisztina Zsebo, president and ceo of Celladon.
‘Lonza’s large-scale viral manufacturing expertise will greatly complement and support our future development and commercialisation efforts for Mydicar.’
