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
관련 제품
| FLEX 선택 | 기술적 우수성 | 단순성 |
|---|---|---|
Fundamental 선택 기본적인 측정 요구사항 충족 |
기술적 우수성
|
단순성
|
Lean 선택 핵심 프로세스를 손쉽게 처리 |
기술적 우수성
|
단순성
|
Extended 선택 혁신적인 기술로 프로세스 최적화 |
기술적 우수성
|
단순성
|
Xpert 선택 가장 까다로운 어플리케이션 요구사항 충족 |
기술적 우수성
|
단순성
구성에 따라 다름 |