Pharma manufacturing news in brief
pharmafile | March 18, 2014 | News story | Manufacturing and Production | Aesica, Alvotech, Codexis/Intrexon, Pluristem, Updates from Bayer
Bayer says it plans to invest more than €500 million to establish additional manufacturing capacity for its haemophilia drugs at its plants in Wuppertal and Leverkusen. The investment is one of the biggest in the drugmaker’s history and will support the roll-out of two recombinant Factor VIII products – BAY 81-8973 and long-acting variant BAY-94-9027 – that are currently in Phase III trials. As part of this investment Bayer HealthCare will create about 500 new jobs at its sites in Leverkusen and Wuppertal by the year 2020.
Iceland’s Alvotech has signed a deal to introduce Finesse Solutions’ disposable production technologies into its commercial-scale manufacturing facility, which started construction last November, as part of a drive into the biosimilars market. Based in California, Finesse specialises in single-use bioprocessing equipment and under the terms of the deal will set up a first manufacturing suite for Alvotech by the end of 2015. Last December, Alvotech said it planned to invest $250 million in the development and manufacturing of a portfolio of biosimilar monoclonal antibodies that should start reaching the market by 2018.
The FDA has granted approval to Israel’s Pluristem Therapeutics to start commercial-scale production of placental stem cells at its facility in Haifa, allowing the firm to support large-scale clinical trials of the cells in a number of clinical indications. Pluristem’s manufacturing process was also backed by Germany’s Paul Ehrlich Institute earlier this year. The Israeli company is already testing placental expanded cells (PLX) in the treatment of peripheral artery disease, pulmonary arterial hypertension and muscle injury.
Biocatalysis specialist Codexis has sold a laboratory in Budapest, Hungary, to US synthetic biology firm Intrexon. The lab will be used by Intrexon’s industrial products division for applications including the bioproduction of active pharmaceutical ingredients for novel anti-infective drugs, said Intrexon in a statement. The acquisition will expand Intrexon’s strain and protein development capabilities, as well as strengthen fermentation process optimisation and scale-up. Having a site in Hungary will strengthen the US firm’s ability to service the European and Asian markets, it added.
Aesica has completed validation of a 10,000 sq. m. expansion of its manufacturing facility in Queenborough, UK, allowing the contract manufacturer to increase commercial production of an unnamed solid dose medicine for type 2 diabetes that is ‘set for worldwide export’. The new facility – built at a cost of $45 million – employs 55 staff and is capable of producing in excess of one billion tablets a year and capacity could be expanded to 2.5 billion tablets if required.
Phil Taylor
Related Content
Alvotech biosimilar receives EC marketing approval
The European Commission (EC) has granted marketing authorisation for Gobivaz, Alvotech’s first-in-market biosimilar of Simponi …
Alvotech and Advanz Pharma announce commercialisation agreement for Eylea biosimilar
Alvotech and Advanz Pharma have announced an exclusive partnership agreement surrounding the supply and commercialisation …
Alvotech and JAMP Pharma’s Jamteki gains marketing authorisation from Health Canada
Alvotech and JAMP Pharma have announced that Health Canada has granted JAMP Pharma marketing authorisation …
