With expertise and know-how in high-end analysis for biologics, Spinnovation Biologics today announces the launch of a breakthrough solution – Spedia-Predict – for Bioprocess performance troubleshooting and performance prediction of bioproduction, at the annual Bioprocess International European meeting.
Spedia-Predict monitors and validates process-critical parameters as a company looks to manage the culture media consistency used in their production environment. Good Manufacturing Practice (GMP) and FDA Quality by Design (QbD) approaches demand close control, but traditional analytical methodology can be costly, time consuming and require sample preparation ahead of measurement. They also lack the ability to characterize 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. Spedia-Predict is designed to rapidly profile most constituents in a medium; it delivers quantitative data and can be applied equally to chemically fully defined or complex media. Spedia-Predict allows identification of markers that can correlate with performance of a specific bioprocess, and monitor batch to batch consistency, for example. As a result, it helps to prevent failure and performance variability in large-scale commercial production, by enabling efficient and cost-effective processes.
Dr Frederic Girard, CEO, 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. Risk factors are reduced and replaced with consistent, reproducible results.”