AMRI, a global contract research, development and manufacturing organization, has more than doubled its current bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity. The addition of a new multipurpose aseptic API line at AMRI’s facility in Valladolid, Spain, enhances capacity at the site and complements its other aseptic API manufacturing plants in Bon Encontre and Tonneins, France.
The sterilization capability can be integrated with API production or operate as a separate outsourced step for customers that do not have bulk sterile facilities or who may need additional capacity. Bolstered by a range of supporting technologies, including customized packing, seeding, milling, micronization, this new line ensures aseptic processing of APIs with tailor-made specifications and control of the physical properties of the final product, including particle size distribution. Further integration is offered with AMRI’s Drug Product capabilities.
“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 customized packaging configuration to improve assembling with customers’ drug product production sites,” said George Svokos, chief commercial officer, AMRI. “Our state-of-the-art 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.”
Additionally, AMRI recently announced the addition of an aseptic pre-filled syringe line at the company’s manufacturing facility in Albuquerque, N.M. 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.