Facilities & Capacity

Manufacturing shutdowns and idle capacity mar Avid’s Q2

Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

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…

Lonza to biomanufacture in China with a little help from GE

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…

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

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…

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

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…

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 Gosseles, 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 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…

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…

Rentschler $34m Austrian plant to feed freeze-drying capacity demand

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…

FDA looks to NIPP inconsistent inspections in the bud

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…