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…
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…
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…
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…
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…
Rentschler Fill Solutions has inaugurated a €30 million ($34 million) fill & finish facility in Austria. The site will produce Mepsevii (vestronidase alfa) drug product for Ultragenyx Pharmaceutical. Construction of the facility began in July 2016, and the plant received GMP approval in August this year. But today (Friday) the contract development and manufacturing organization (CDMO) officially inaugurated the facility in Rankweil, Austria. The clinical and commercial plant forms part of Rentschler Biotechnologie’s strategic alliance with Leukocare, which aims to…
The New Inspection Protocol Project (NIPP) intends to increase the speed and efficiency of sterile injectable facility inspections through the semi-automated generation of establishment inspection reports (EIRs). In efforts to modernize inspections program, the US Food and Drug Administration (FDA) has developed a new protocol to assess, record and report the data from surveillance and pre-approval inspections for sterile drug products. “The New Inspection Protocol Project (NIPP) is focused on modernizing our inspection approach and enabling continual improvement of our…
South Korea’s financial regulator has concluded Samsung BioLogics inflated its value ahead of its initial public offering (IPO) in 2016. The CDMO says it is filing an administrative lawsuit to clearly prove the legality of its actions. In April this year, South Korea’s financial regulators accused contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud, following a yearlong audit. Today the Securities and Futures Commission (SFC) ruled that Samsung BioLogics intentionally violated accounting rules by changing the accounting…
Abzena will have two 500 L bioreactors and one 2,000 L bioreactor supplied by Sartorius at its San Diego facility once additional capacity comes online next year. Biologics services firm Abzena has increased its manufacturing capacity through a $20 million (€17.8 million) investment at its drug substance and antibody-drug conjugate (ADC) facility in San Diego, California. “The investment decision has been driven by demand from existing and new customers moving through from cell line development and those already utilizing our…
Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO. For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year. “Supply challenges continued to impact product availability in the third quarter,†CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further…