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.

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.

Customer challenges

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Alvotech chose We 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:

Our solution

▖Raman Rxn2 analyzer

▖Rxn-10 probe

▖Raman flow assembly

▖Faster processing time: real-time monitoring and adjustment of the UF/DF process eliminate                process pauses, resulting in streamlined operations

▖Process optimization: instant analytical results enable proactive                    decision-making, enhancing overall efficiency