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…
Monday, December 10, 2018 Daily Archives
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…