Novo Nordisk spent $1.5 billion on CapEx in 2018 and expects to pay a further $1.4 billion in 2019 driven by investment in drug substance at its North Carolina site. Danish drugmaker Novo Nordisk had a flat year in 2018, pulling in sales of DKK 112 billion ($17 billion). Net profit remained relatively constant too, with the firm reporting DKK 39 billion ($6 billion). According to CFO Karsten Munk Knudsen, “manufacturing had a fantastic year in 2018. He told stakeholder:…
Three months after production began at its 180,000 L facility, CDMO Samsung BioLogics says it has filled 25% of its capacity. In October 2018, South Korean contract development and manufacturing organization (CDMO) Samsung BioLogics started commercial production at its third facility located at its Songdo, Incheon site. The plant has been touted as the world’s largest single biomanufacturing facility, boasting 180,000 L of capacity from 12 15,000 L stainless steel tanks, and according to Samsung BioLogics’ 2018 results, it is…
Amgen’s commitment to next generation biomanufacturing has led to a reduction in its facility footprint of nearly a quarter since 2013. In 2013, Amgen commenced a “company-wide re-engineering process†aimed at transforming its business to prepare for long-term growth. The restructure included significant job cuts and plans to reduce facility footprint by 23%, while ensuring increased bulk production through next-generation biomanufacturing platforms. Five years on, and David Meline, Amgen’s CFO, said the firm has successfully transformed “the business “to achieve…
Commercial production by CDMO Lonza follows the recent US FDA nod for Portola’s Prior Approval Supplement (PAS) for recombinant factor Xa product Andexxa. FDA approval of Portola Pharmaceuticals, Inc.’s Prior Approval Supplement (PAS) for second-generation Andexxa follows collaboration with Lonza Pharma & Biotech to develop the manufacturing process The production of this second-generation Andexxa [coagulation factor Xa (recombinant), inactivated] has now begun, with Swiss contract development and manufacturing organization (CDMO) Lonza supplying the recombinant coagulation factor from its Porriño, Spain…
GE Healthcare will equip G-CON’s prefabricated cleanrooms with its cell therapy and viral vector technologies in the latest expansion of its partnership. The collaboration aims to incorporate GE Healthcare’s cell therapy and viral vector technologies and process design within G-CON’s prefabricated flexible cleanrooms (known as ‘PODs’) in efforts to speed up and offer flexibility to customers’ advanced therapy projects. “This collaboration is unique because it provides our customers with an entire cleanroom infrastructure from a single source and will improve…
The US Biomedical Advanced Research and Development Authority (BARDA) has exercised a second option in its smallpox vaccine contract with Bavarian Nordic. In September 2017, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million). To support the agreement, BARDA exercised an option in 2017 to cover development costs associated with the Phase III study of the…
In the latest example of a Big Biopharma reducing its biosimilar presence, Pfizer has abandoned five of its preclinical programs. The decision is part of an R&D review set to cut 150 jobs in Illinois and India. In November 2018, Bioprocess Insider reported claims that Big Pharma is set to exit from the biosimilars space over the next five years. Within weeks of publishing, Boehringer Ingelheim joined the likes of Germany’s Merck KGaA and Novartis division Sandoz in abandoning elements…
After raising $324 million last year, Allogene Therapeutics says it is planning to construct a cell therapy manufacturing facility near San Francisco, California. Allogene Therapeutics is focused on developing allogeneic, or off-the-shelf, T cell. In October 2018, the San Francisco-headquartered firm raised $324 million (€283 million) in an initial public offering (IPO). Since its launch, the cell therapy firm has been working with a contract manufacturing organization (CMO) but now Allogene has told BioProcess Insider that it plans to build…
Lonza will increase its mammalian process development and small-scale cGMP manufacturing capabilities through a multi-million pound investment at its Slough, UK site. Swiss contract development and manufacturing organization (CDMO) has told BioProcess Insider it is making a “multi-million pound investment†into its facility in Slough, UK. The site, located around 40km west of London, serves as Lonza’s center of excellence for mammalian biopharmaceutical process development and small-scale cGMP manufacturing, primarily for clinical phases. It also offers a range of analytical…
Two Colorado facilities acquired from Amgen will be closed as AstraZeneca looks to consolidate drug substance manufacturing at its site in Frederick, Maryland. Anglo-Swedish pharma giant AstraZeneca is ending operations at its facility in Boulder, Colorado and the nearby Longmont plant less than four years after acquiring them from Amgen. The decision to shutter the sites was made as part of AstraZeneca’s biomanufacturing consolidation strategy, a spokesperson from the firm told BioProcess Insider. “AstraZeneca has made the decision to consolidate…