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Pharmaceutical manufacturing is reliant upon bioprocessing approaches to generate the range of therapeutic products that are available today. The high cost of production, susceptibility to process failure, and requirement to achieve consistent, high-quality product means that process monitoring is paramount during manufacturing. Process analytic technologies (PAT) are key to ensuring high quality product is produced at all stages of development. Spectroscopy-based technologies are well suited as PAT approaches as they are non-destructive and require minimum sample preparation. This study explored the use of a novel attenuated total reflection Fourier transform infrared (ATR-FTIR) spectroscopy platform, which utilises disposable internal reflection elements (IREs), as a method of upstream bioprocess monitoring. The platform was used to characterise organism health and to quantify cellular metabolites in growth media using quantification models to predict glucose and lactic acid levels both singularly and combined. Separation of the healthy and nutrient deficient cells within PC space was clearly apparent, indicating this technique could be used to characterise these classes. For the metabolite quantification, the binary models yielded R2 values of 0.969 for glucose, 0.976 for lactic acid. When quantifying the metabolites in tandem using a multi-output partial least squares model, the corresponding R2 value was 0.980. This initial study highlights the suitability of the platform for bioprocess monitoring and paves the way for future in-line developments.

Diagnosing brain cancer is frequently difficult and requires specialist equipment. Here, the authors develop their previous attenuated total reflectance-Fourier transform infrared spectroscopy method and incoporate the use of disposable silicon wafers for diagnosing brain cancer using serum samples.

Abstract Biofluid spectroscopy is an emerging technology in the field of clinical investigation, providing a simple way to extract diagnostic and observational information from easy to acquire samples. Infrared spectroscopy is well suited to analyse a large range of biofluid samples, including blood and its derivatives, due to flexible sampling modes and high sensitivity to subtle biological changes. As the technology advances towards the clinic, factors influencing successful clinical translation are becoming apparent. Here, we provide a tutorial for effective biofluid spectroscopy study design, discussing sample and instrument parameters, as well as clinical considerations. The aim is to present the current understanding of clinical translation in the field of biofluid spectroscopy, and to facilitate other clinical applications to advance to the clinic.