Bulk API aseptic manufacturing capacity expanded by AMRI

AMRI, a global contract research, development and manufacturing organisation, has doubled its bulk active pharmaceutical ingredient (API) aseptic manufacturing capacity with the addition of a multipurpose aseptic API line at its facility in Valladolid, Spain.

“This investment supports our intent to serve our customers’ increasing demand for aseptic APIs linked to the need for physical control of these APIs and customised packaging configuration to improve assembling with customers’ drug product production sites,” said George Svokos, chief commercial officer, AMRI. “Our lines are designed to meet requirements from pilot-scale to multi-ton scale manufacturing. Our team on the sterile lines has decades of experience creating the appropriate conditions for the media fill (aseptic process simulation) and process validation, even for very difficult-to-handle or sensitive products.”

In addition to the investment at its Spanish site, the company has also added an aseptic pre-filled syringe line at its facility in Albuquerque, New Mexico. This investment supports the company’s aim to have the capacity and technology to serve the increasing demand from customers and meet the evolving requirements for healthcare professionals and patients.