Part of the special news roundup of DCAT member companies for the DCAT Week ’17 Special Edition of DCAT Value Chain Insights (April 5, 2017)
Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, has expanded its service portfolio to include contract manufacturing of highly potent solid oral dose medicines. The service will be provided at the Pfizer Newbridge, Ireland facility, now part of Pfizer CentreOne’s contract manufacturing network. The site is currently approved to supply pharmaceuticals in more than 100 markets and has received regulatory approval from the US Food and Drug Administration, the European Medicines Agency, Agência Nacional de Vigilância Sanitária of Brazil, and the Pharmaceuticals and Medical Devices Agency in Japan.
The Newbridge site manufactures high-potency non-cytotoxic solid oral dosage forms for human use. In addition to conventional manufacturing processes, the site has experience with compounds that require complex processes, such as modification of powder and particle properties or enhanced solubility and dissolution properties.
This addition of solid oral dose manufacturing of highly potent medicines follows an earlier expansion in February 2017 of Pfizer CentreOne’s fill-finish services at its Kalamazoo, Michigan site, which now provides vial-filling of sterile suspensions along with vial-filling of small molecules and biologics. Pfizer CentreOne’s vial-filling services include small molecules and biologics, sterile suspensions, potent and controlled substances, aqueous and oil-based formulations, lyophilization, vials in 1-mL to 100-mL sizes, bulk formulation ranging from less than 1 liter to 1,600 liters, and technical transfer.
Pfizer CentreOne was formed by the union of Pfizer CentreSource and Hospira One 2 One, a sterile-injectables CMO, following Pfizer’s $17-billion acquisition of Hospira in 2015. Pfizer CentreOne focuses on active pharmaceutical ingredient synthesis, sterile injectables fill-finish, and highly potent solids.
Source: Pfizer CentreOne