Manufacturing & Bioprocessing
Shorten process development cycles, increase product yields and improve efficiency
The development, scale-up and manufacture of a biopharmaceutical continues to increase in both complexity and regulatory requirements. All aspects of a bioprocess must be optimized for the highest possible titers with the most cost-effective production. This requires an understanding of all critical process parameters that can have an impact on scalability, quality, and control. Metabolomics is a direct assessment of the active biological system and the factors that influence it, making it the ideal tool to improve predictability, quality and control. Metabolon’s Bioprocessing Insight Assessment is built upon our Precision Metabolomic global platform to take a comprehensive approach to provide specific insight on media/feed optimization, scale-up, cell line selection, batch fingerprinting and quality predictors to better understand and control your bioprocess.
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Metabolomics is a direct measure of the active biology of a system assessing all complex factors that can influence the production process, including genetic, environmental and nutritional influences. Rather than being limited to media measurements alone, metabolomics greatly increases the coverage and resolution of the biochemical space by evaluating both cells and media, giving more insight and information to guide your process strategy. Metabolon’s Precision Metabolomics global platform provides the broadest coverage of metabolites in the industry so you can have confidence in your process design strategy with the deepest understanding of inputs and parameters.
While traditional technologies and competing analysis approaches focus only a conventional set of 10-20 biochemicals in culture media only, Metabolon’s industry leading library of biochemicals is applied to both cells and media to inform on 300 to 600 biochemicals providing the most comprehensive assessment to fully inform process development and optimization. Covered areas of metabolism include:
- Amino acid metabolism
- Carbohydrate metabolism
- Cofactor & vitamin metabolism
- Energy metabolism
- Nucleotide metabolism
- Lipid metabolism
Controlling cost and quality of a bioprocess starts with a quality by design approach to process development, which requires deep understanding of critical process parameters. Metabolon’s Bioprocessing Insight Assessment informs this critical step with better characterization of cell lines, informing on media and feed strategies and evaluating scale-up stability. However metabolomics can be applied throughout the process life-cycle to reduce variability, monitor both intended and unintended changes that can influence critical quality attributes, assess raw materials and identify predictors (i.e. biochemical biomarkers) of performance and product quality for a robust continuous monitoring program.