Sandoz launches into cell culture synthesis
manufacturing plants in Austria and Slovenia that mark its entry
into the contract manufacture of biopharmaceuticals using mammalian
cell culture.
The company is already active in the use of microbial fermentation to manufacture biopharmaceuticals, but sees the extension of its capabilites into cell culture as essential to allow it to keep pace with the market for biologicals, which is currently growing at a double-digit pace.
The first site, based in Schaftenau in Austria, cost €50 million to set up and allows the company to make products that it could not before, such as monoclonal antibodies. This plant should be ready for contract production in the second half of this year, said Friedrich Nachtmann, head of biotech cooperations at Sandoz.
The new facility comprises a 100-litre line for producing initial batches for clinical trials, and two production-scale fermenters with capacities of 3,000 and 13,000 litres. Both fermentation units can be operated in batch mode and have downstream processing lines with isolation and purification technologies.
"The expansion underscores the strategic importance of Sandoz' new biopharmaceuticals franchise," said the company in a statement. Just a year ago, the company opened a new 13,000 litre fermentation plant for biopharmaceutical production using microbial technology at its neighboring Kundl site.
The second site, located near Ljubljana in Slovenia and operated by Novartis subsidiary Lek Pharmaceuticals, is equipped with two 200 litre perfusion fermenters, used for continuous production. It is the first of its kind inCentral and Eastern Europe, and cost €18 million.
Sandoz has a longstanding expertise in biotechnological pharmaceutical production and was one of the world's first manufacturers toproduce a recombinant protein (interferon) on an industrial scale, in 1981.
The company is also a pathfinder in the embryonic market for biogenerics - or what scientists now prefer to call 'comparable biopharmaceuticals.'
Company spokeswoman Claudia Arthur-Flatz told In-Pharmatechnologist.com that its Omnitrop brand of human growth hormone was recommended for approval by the European Medicines Evalution Agency's Committee for Proprietary Medicinal Products last June, and is awaiting full approval by the the EMEA.
Omnitrop remains the first and only comparable biopharmaceutical going through the regulatory process in Europe, and a dossier for the product has also been submitted - and accepted - by the US Food and Drug Administration.
Sandoz would not be drawn on whether the new cell culture capability would lead to additional activity in the biogeneric sector.
