Canadian manufacturer Dalton Pharma Services has bagged a new contract with Affectis Pharmaceuticals for the production of preclinical toxicology material with potential for cGMP manufacture of the German firm's new antidepressant drug.
This is the first contract the contract manufacturing organisation (CMO) has signed since it was given the green light to start offering sterile and commercial manufacturing services to its customers.
The go ahead was given after the CMO received a compliant rating from the Canadian regulator for its plant located in Toronto.
"Our relationship with Affectis was solidified upon the successful completion of Health Canada's audit of our manufacturing facilities," said Peter Pekos, president and CEO of Dalton Pharma Services.
"We are confident the Establishment License we have recently attained will attract and fulfil other commercial pharmaceutical manufacturing relationships within the EU."
Meanwhile, Granules India has signed an outsourcing deal with Australian drugmaker Matchland to manufacture several of its finished dosage products aimed at the Australian market.
Five of Matchland's products have been identified for initial manufacturing and the list is anticipated to grow as the relationship progresses, the companies said.
They added that the manufacturing process is expected to start as soon as possible.
This latest deal represents Matchland's first outsourcing agreement with an Indian company.
It also complements Granules' strategy of expansion into lesser explored markets like Australia and New Zealand.
In other contract manufacturing news, Swiss CMO Lonza has successfully completed the manufacture of Athersys's clinical-grade master cell bank and initial product doses intended to support its clinical trial activity in 2007 and 2008.
US-based Athesys is currently developing Multistem - a multipotent adult progenitor cell (MAPC)-based product - to treat patients for certain cardiovascular disorders, stroke, bone marrow transplantation, and oncology support.
The stem cells are isolated from the bone marrow and other nonembryonic tissue sources that have the potential to develop into a range of cell types and can be expanded ex vivo while retaining their potency, according to Athersys.
The company picked Lonza to help it in the scale-up and manufacturing of its product, using Athersys's production processes.
"We are excited about this relationship and our role in supporting Athersys's entry into the clinic with its MultiStem product," said David Smith, vice president of Cell Therapy Bioservices at Lonza.
"Athersys's production process has proven to be robust and scalable, providing a strong foundation for conducting clinical development."