Author Archives: Dan Stanton

Belgian CDMO MaSTherCell doubles cell therapy capacity

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…

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)…

Axovant looks to CDMO Yposkesi for gene therapy scale up

Axovant Sciences has selected French CDMO Yposkesi as a strategic partner to help bring its neurologic and neuromuscular gene therapy candidates through the clinic. Contract development and manufacturing organization (CDMO) Yposkesi will utilize its adeno-associated virus (AAV) and lentiviral vector production capabilities to service the strategic agreement with Axovant. Swiss biotech Axovant has a pipeline of gene therapies targeting neurological and neuromuscular diseases. Financial details have not been divulged, but Alain Lamproye, CEO of Yposkesi, said it is a straight…

Bayer takes $680m hit on German factor VIII plant

Bayer is abandoning a facility in Germany in plans to concentrate all hemophilia factor VIII protein production at its plant in Berkeley, California. The decision comes as part of a full business restructure, which will axe 12,000 jobs. In 2014, Bayer invested more than €500 million ($568 million) into its recombinant factor VIII (rFVIII) hemophilia manufacturing network, including establishing additional capacity at a plant in Wuppertal, Germany. But as part of a significant business shake-up announced yesterday, the German drugmaker…

Teva settles with Roche to launch first Rituxan biosimilar in US

Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…

Aji Bio enters ‘rapidly growing’ ADC space

Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times. According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached. “The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,” Jason…

Boehringer Ingelheim abandons biosimilars outside the US

German drugmaker Boehringer Ingelheim will not commercialize its approved adalimumab product Cyltezo in Europe and is discontinuing all biosimilar development activities outside the US. Earlier this month, an article published in Bioprocess Insider considering the impending exit of Big Pharma from the biosimilars space brought a lot of attention from industry and investors. The piece drew on Merck KGaA’s abandonment of its biosimilars programs in 2017 as an example, and now fellow German Big Pharma firm Boehringer Ingelheim is contemplating…

GE plans purification platform production plant post Puridify purchase

GE Healthcare will open a biomanufacturing center in Stevenage, UK to support production of its fiber-based purification platform, which it acquired last year. In November 2017, bioprocessing equipment and consumables vendor GE Healthcare acquired Puridify – a spin-out from University College London, UK – for an undisclosed fee. The deal added early-stage tech platform FibroSelect, consisting of a nanofiber-based material to which ligands are attached to activate the platform for purification of biologics. A year on and the firm has…

Continuous gene therapy production targeted in UK collaboration

Cobra Biologics and the Cell and Gene Therapy (CGT) Catapult have teamed with Pall to explore continuous manufacturing of gene therapies. The project builds on a concurrent collaboration which looks to reduce the cost of adeno-associated virus (AAV) vectors. The collaboration received a £1.5 million ($1.9 million) shared grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications. “The project is a joint collaboration between Cobra, Pall and the…

WuXi building twelfth plant as biologics contracts ramp up

With a portfolio approaching 200 products, CDMO WuXi Biologics has begun constructing a 1.6 million square-foot facility in Shanghai, China. Contract development and manufacturing organization (CDMO) WuXi Biologics is building what it calls a ‘Biologics Innovation Center’ in Fengxian, Shanghai. The 1.6 million square-foot facility will include biologics discovery and development laboratories, as well as GMP manufacturing, CEO Chris Chen told BioProcessing Insider. He added the labs will open in 2019, while the GMP plant will open its doors in…