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news.Stratophase, a supplier of nonlinear optical materials including periodically poled lithium niobate and GSK have become part of a syndicate involved in developing a multi-parameter device, which can track essential criteria required to implement Quality by Design (QbD) in API production, reported in-PharmaTechnologist.
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The syndicate, which also includes Green Biologics and The Centre for Process Innovation, is designing Stratophase’s SpectroSens technology. Stratophase is heading a $1.8m project aimed at catering to the QbD needs of manufacturers of active pharmaceutical ingredients (API). Production of butanol-based biofuels is also a part of this project.
Currently, SpectroSens technology can track liquids using measurements related to temperature and refractive index. The project’s target is to increase the device’s measurement parameters, adding spectroscopic information,pressure, viscosity and particle content.
Stratophase claimed that this information can provide highly accurate, real-time and data-rich description of different manufacturing steps. This can be used minimize waste and increase yields by allowing for tighter and more timely control.
Richard Williams, CEO of Stratophase, told in-PharmaTechnologist that a single integrated multi-parameter device comes with various advantages. Primarily, it makes the system easier to implement and allows for complex data analysis as measurements are all from the same source.
According to Mr Williams, multiple parameter measurement provides for the possibility of complex process modelling, unlike single measurements, and can be a challenging data integration activity if different measurement systems are used and the data is analyzed subsequently.
The US FDA is interested to see companies implement QbD principles to meet Process Analytical Technology (PAT) requirements.