Industry experiences in continuous manufacturing for encapsulation and tableting

Abstract

Takeda Pharmaceuticals, which acquired Shire Pharma's continuous manufacturing expertise when it bought the company, has continued continuous research and piloting efforts begun by Shire in 2016, according to Jim Bonner, Takeda's director of small-molecule drug product, who spoke in the program (1). The company has completed trial runs using near-infrared (NIR) and Raman spectroscopy, which involved scanning 30 different blends three times, then using product of least squares-based chemometric methods on reference gravimetric rather than high-performance liquid chromatography assay data. Andrew Farrington, principal scientist for oral formulation sciences at Merck in West Point, PA, discussed the company's pilot project, designed to build upon existing expertise in real-time release testing, raw materials monitoring, and quality by design (2).