Raman downstream process measurement of biosimilars
Alvotech’s testing of the protein purification process during ultrafiltration/diafiltration (UF/DF)
Find out how Alvotech is enhancing its downstream processing for biosimilar production by enabling real-time monitoring of the protein purification process during UF/DF. The result? The company can realize cost savings, faster processing, and more proactive decision making for increased efficiency.
Benefits can include:
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Cost savings: reduced labor, buffer solution, and offline analysis costs lead to significant savings
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Faster processing time: real-time monitoring and adjustment of the UF/DF process eliminate process pauses, resulting in streamlined operations
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Process optimization: instant analytical results enable proactive decision-making, enhancing overall efficiency
Customer challenges
Downstream phase process development requires a PAT that accommodates reduced volumes and shorter cycle times. However, efficiency improvements for downstream applications are hindered by technological challenges, such as reliance on extractive analytical methods for composition measurement, slow response times, insufficient nominal ranges, background interferences, and more. The complexity of purification steps, driven by intensified upstream processes, needs innovative downstream solutions.
Our solution
Alvotech chose Endress+Hauser to test in-line Raman spectroscopy in upstream and downstream process development. The selected Raman system is tailored for downstream flow paths, leveraging signal amplification and low-noise technology to deliver faster results. It consists of the following components:
Raman Rxn2 analyzer
Rxn-10 probe
Raman flow assembly
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