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Cell culture process development and optimization is critical for the commercially viable production of recombinant protein products. It will impact the downstream production and manufacturing processes including scalability and costs. Spinnovation Biologics service offers advanced insights into cell culture process to enhance productivity, scalability, and reliability for cGMP production and support Quality by Design. We perform high throughput analyses on multiple factors influencing your cell culture system to identify the optimal nutritional and process conditions, address issues related to impurities or identify the causes of variation in the culture process. We help clients operating at pilot production process stages through to cell expansion to bioreactor harvest, including cell growth and production phases. We help you to optimize upstream performance by providing the data to help you to refine cell growth conditions, media or production conditions and feeding strategies. Contact us to see how we can help you refine and/or better control your development and production process.
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Download our recent paper on the use of NMR for characterizing process impurity in biologics