CRO OzUK has announced the availability of a new GLP pilot plant designed for pilot and feasibility studies of both solution and suspension MDIs filled with low global warming potential (LGWP) propellants. OzUK announced plans for the new facility in December 2023. According to the company, the new facility meets ATEX (Atmosphères Explosibles) standards for safety, allowing production of metered dose inhalers with HFA 152a or HFO1234ze.
OzUK says that the choice of GLP compliance is intended to speed development: “Operating under GLP standards offers our clients a streamlined approach to testing, stability studies, and iterative development, providing valuable data without the constraints of full GMP. This flexibility enables pharmaceutical companies to refine formulations and conduct stability assessments with ease, making it faster and simpler to evaluate the potential of new or reformulated molecules before scaling up to GMP manufacturing”
In September 2022, H&T Presspart announed a partnership with OzUK on development services for MDIs using LGWP propellants. The following year, Recipharm (now Bespak) announced a similar partnership with OzUK for development and manufacturing of LGWP MDIs.
Read the OzUK announcement.
