Dutch contract research organisation Spinnovation Biologics’ new Spedia-Predict monitors and validates process-critical parameters when managing culture media consistency used in bioproduction.
The Nijmegen-based firm says Good Manufacturing Practice (GMP) and FDA Quality by Design (QbD) approaches to bioproduction demand close control, but traditional analytical methodology can be costly, time consuming and require sample preparation ahead of measurement. It also lacks the ability to characterise chemically complex media. As a result, many companies monitor only a handful of components, failing to get the complete picture and missing information on how it will perform in scale-up.
Spinnovation Biologics says Spedia-Predict rapidly profiles most constituents in a medium; it delivers quantitative data and can be applied equally to chemically defined or complex media. For example, it allows identification of markers that can correlate with the performance of a specific bioprocess, and monitor batch to batch consistency. As a result, it can help to prevent failure and performance variability in large-scale commercial production.
Spinnovation’s chief executive Dr Frederic Girard, said: ‘Using Spedia-Predict we help our clients to understand and monitor the factors that are most influential to their cell culture performance. This is a huge advantage. Importantly, we provide information early in production planning – effectively establishing a QC standard – which can then be used in routine manufacturing to reduce the risk of process failure, and increase the consistency in production performance.’
The firm says its core expertise in Nuclear Magnetic Resonance Spectroscopy (NMR) and Mass Spectrometry (MS) to study molecules and materials is increasingly being applied in the biopharma production environment.
