The US Food and Drug Administration (FDA) is keen to see companies employ Quality by Design (QbD) principles to meet Process Analytical Technology (PAT) requirements. This has increased demand for technologies that can capture the necessary production data.
Stratophase is leading a £1.2m ($1.8m) project focused on meeting the QbD needs of manufacturers of active pharmaceutical ingredients (API). Production of butanol-based biofuels is also in the project’s remit.
The consortium, which also includes GlaxoSmithKline (GSK), Green Biologics and The Centre for Process Innovation, is developing Stratophase’s SpectroSens technology.
SpectroSens is currently capable of monitoring liquids using measurements associated with temperature and refractive index. The project aims to increase the device’s measurement parameters, adding spectroscopic information, particle content, pressure and viscosity.
Capturing this information can provide highly accurate, real-time and data-rich ‘fingerprints’ of various manufacturing steps. This can be used minimise waste and increase yields by enabling tighter and more timely control.
Richard Williams, CEO of Stratophase, explained to in-PharmaTechnologist that a single integrated multi-parameter device has several benefits. Firstly, it makes the system easier to implement and allows for complex data analysis as measurements are all from the same source.
He added: “Multiple parameter measurement allows for the possibility of complex process modelling, which is not possible with single measurements, and can be a challenging data integration activity if different measurement systems are used and the data subsequently analysed.”
Williams expects prototype systems using technology developed by the consortium to be available over the coming year. These will be validated within the project, which is due to run for two years, leading to Stratophase incorporating them into its product range.
The Technology Strategy Board has joint-funded the project. Matched funding from the board “requires a percentage of the funds to be committed by the consortium, although the exact funding rate is dependent upon the individual organisations’ status”, added Williams.