Author Archives: Dan Stanton

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

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The US FDA observed potential mold contamination and deficient aseptic processes during an inspection at Pfizer’s fill/finish facility in McPherson, Kansas. The McPherson facility was one of several manufacturing plants added to Pfizer’s network following the $17 billion (€14.9 billion) acquisition of Hospira in 2015. The plant has been subject to various regulatory issues, resulting in a US Food and Drug Administration (FDA) warning letter in February 2017 citing poor aseptic processing and repeat GMP violations. An October 2017 inspection resulted…

December 10, 2018

Lonza to biomanufacture in China with a little help from GE

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Changing policies in China bring opportunities for foreign CDMOs says Lonza, which is opening a biologics facility in Guangzhou, supported by GE Healthcare. Swiss contract development and manufacturing organization(CDMO) Lonza has announced it is constructing its first biomanufacturing facility in China. The 17,000 m² plant will be based on GE Healthcare’s off-the-shelf modular biologics factory, KUBio platform, and will supply antibody drugs to the local market. “We do have an established presence in China and in theGuangzhou district but this…

December 10, 2018

French staff cuts but Sanofi committed to $800m biomanufacturing plans

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Sanofi will cut 750 jobs in France but says it remains committed to biologic and vaccine manufacturing investments totaling €700 million ($800 million) in the country. With civil unrest breaking out on the streets of Paris as members of the so-called ‘Gilets Jaunes’ demand everything from lower taxes to better job security, France’s largest biopharma firm Sanofi has revealed plans to reduce its domestic workforce by 750, and scrap plans to recruit a further 250 staff. “Sanofi in France informed…

December 7, 2018

Novo Nordisk pumps further $22m into NC drug product site

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Less than a year after beginning a $65 million expansion at its Clayton diabetes finished products plant, Novo Nordisk has announced a further capacity investment. In February 2018, Novo Nordisk announced plans to up capacity at its finished product plant in Clayton, North Carolina through a $65 million (€74 million) aimed at fulfilling the demand for its diabetes and obesity medicines. Ten months on, and the Danish drugmaker has committed a further $22 million to the site and will add…

December 7, 2018

J&J and Merck team with UK gov on $97m vaccine manufacturing center

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The UK government-led Vaccines Manufacturing Innovation Centre will have pilot and medium-scale capacity and the ability to respond to threats of serious infections. The center, to be built in Oxford, UK will focus on the production of vaccines for outbreaks of diseases such as Ebola and Lassa fever, bridging the gap between academia and industry. The project has been funded by the UK government’ Industrial Strategy, a business-backing program from the Department for Business, Energy & Industrial Strategy aimed at…

December 5, 2018

Gilead hopeful for allogeneic IND next year

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Gilead, which has already seen success with an autologous CAR-T therapy, says it hopes to submit an Investigational New Drug (IND) request for an off-the-shelf product in 2019. In August 2017, Gilead Sciences acquired Kite Pharma for $11.9 billion (€10.5 billion). Weeks later, the firm became only the second to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy through the Kite-developed product Yescarta (axicabtagene ciloleucel). Yescarta is an autologous product, meaning it…

December 5, 2018

Belgian CDMO MaSTherCell doubles cell therapy capacity

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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…

December 4, 2018

Amgen on Soliris: Low patient population but high biosimilar potential

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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)…

December 4, 2018

Axovant looks to CDMO Yposkesi for gene therapy scale up

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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…

December 3, 2018

Bayer takes $680m hit on German factor VIII plant

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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…

November 30, 2018