MaSTherCell will be able to manufacture about 1,000 batches a year through the expansion, helping to feed the high demand for cell therapy production. The contract development and manufacturing organization (CDMO) unveiled a 600 m2 wing at its site in Gosselies, Belgium, effectively doubling its cell therapy production capacity through five extra clean rooms. “Each clean room is about 30 m²,†Romain de Rauville, head of Business Development Europe at MaSTherCell, told this publication. “The capability depends on the process…
Tuesday, December 4, 2018 Daily Archives
Amgen on Soliris: Low patient population but high biosimilar potential
The high cost of Alexion’s ultra-orphan disease MAb Soliris (eculizumab) drove Amgen’s decision to develop a biosimilar version, says SVP of Global Development Elliott Levy. Soliris (eculizumab) is an approved treatment for orphan diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (a-HUS) treatment. The monoclonal antibody (MAb) was – until the arrivals of CAR-T and gene therapies Kymriah, Yescarta and Luxturna last year – the most expensive drug in the world, and netted Alexion $3.1 billion (€2.8 billion)…