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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.

Alvotech case study for downstream bioprocessing ©Endress+Hauser

Benefits can include:

  • Cost savings: reduced labor, buffer solution, and offline analysis costs lead to significant savings

  • 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

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

  • Basit ürünler

  • Seçmesi, kurması ve çalıştırması kolay

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  • Standart ürünler

  • Güvenilir, sağlam ve az bakım gerektiren

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  • Üst düzey ürünler

  • Son derece fonksiyonel ve uygun

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  • Özelleştirilmiş ürünler

  • Zorlu uygulamalar için tasarlanmış

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Değişken

FLEX seçimleri Teknik mükemmellik Sadelik
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Fundamental seçim

Temel ölçüm ihtiyaçlarınızı karşılayın

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Lean seçim

Ana proseslerinizin üstesinden kolayca gelin

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Extended seçim

Proseslerinizi yenilikçi teknolojilerle optimize edin

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Xpert seçim

En zorlu uygulamalarınızda uzmanlaşın

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