Avid seals manufacturing contract
The agreement will see Avid manufacture supplies of the drug in its current good manufacturing practice (cGMP) compliant facility.
In addition it will provide cell bank preparation, process development and prepare the manufacturing section of the US Food and Drug Administration’s (FDA) Investigational New Drug Application (INDA). Financial details of the deal have not been disclosed.
Steven King, president of Avid, said: "This agreement with Catalyst Biosciences for their lead clinical candidate is the most recent example of the traction we are gaining as a trusted provider of cGMP manufacturing services, as well as our broad capabilities as a provider of valuable ancillary services."
Catalyst’s CB 813 is intended to be an improved version of factor VIIa, for treating acute bleeding in haemophilia patients. It is anticipated that an INDA will be filed for the candidate early in 2009.
Manufacture of CN 813 will take place at Avid’s facility in Tustin, California, which has been designed to produce monoclonal antibodies and therapeutic proteins derived from mammalian cell culture.
The facility contains stirred tank bioreactor systems, which can be operated in batch, fed-batch or perfusion mode to provide flexibility to clients.
Avid’s bioreactors are computer controlled to monitor and maintain growth and productivity parameters, with this information available for record keeping after completion of the run.
The deal with Catalyst follows Avid’s contract with Crucell to manufacture PER.C6 for the west coast of the US. Avid’s success in securing manufacturing contracts has led to it drafting expansion plans to provide additional capacity.
