Mesoblast to start commercial stem cell production

Melbourne-based Mesoblast (ASX:MSB) has signed a process development and manufacturing agreement with US life sciences company Cambrex Corporation (NYSE:CMB) for the large scale production of Mesoblast's adult stem cells.

Under the agreement, Cambrex will produce clinical grade cells to be used in US-based human clinical trials and meeting Good Manufacturing Practices (GMP).

"It's about reducing costs, being able to scale up, being able to satisfy the FDA [US Food and Drug Administration] that we've got professional capabilities and it satisfies potential corporate partners that we have a process that's ready to not only to move into clinical trials but that's ready to be translated into direct commercialisation," said Mesoblast's chief scientific advisor Prof Silviu Itescu.

Cambrex's facilities are FDA approved and the GMP manufacture of Mesoblast's stem cells will form an important component of Mesoblast's submissions to the FDA for Investigational New Drug (IND) approvals.

"We expect to have our filing in place by some time during the course of next year," said Itescu.

The cells will be produced under the same manufacturing process as that used at the Peter MacCallum Cancer Institute's Cell Therapies.

"The two organisations are already working very closely together," said Itescu. "We have identical protocols for the pilot study in Australia and for the larger trials in the US."

A series of human pilot trials of Mesoblast's stem cells are scheduled to commence in later this year. Mesoblast is investigating the use of its stem cells for the treatment of a range of orthopaedic and cardiovascular conditions.