AMRI recently added a new multipurpose aseptic API line at its facility in Valladolid, Spain.
“This new line – supported by a range of technologies – ensures aseptic processing of APIs with tailor-made specifications and control of the physical properties of the final product, including particle size distribution,” George Svokos, chief commercial officer at AMRI told us.
The contract research, development, and manufacturing organization (CDMO) also recently announced the addition of an aseptic pre-filled syringe line at the company’s manufacturing facility in Albuquerque, NM, which Sovokos said adds the capacity to manufacture roughly 50m syringes per year.
“There is growing interest by customers toward biologics, controlled substances, and other complex compounds, and our intent is to remain a key player for complex and sterile API development and manufacturing, as well as sterile dosage form development and manufacturing,” he added.
As Svokos explained, there is "an evolution of pharma pipelines" and an increasing need for sterile API.
"According to industry analysis, there are many parenteral products (existing and being approved) in the form of sterile suspensions and other such presentations – including certain inhaled or ophthalmic products – that require the use of sterile API in their manufacturing," he said, citing a Pharmaprojects Pharma R&D Annual Review. "This feeds well into our Drug Product business, which has capabilities in these types of sterile suspensions."
Over the past year, the Albany, NY-headquartered CDMO – which was acquired by a private equity firm in September – has invested more than $10m in its Spain facilities