14 Questions
What was the primary reason for the lower environmental burden of the single-use process over the stainless steel process?
Reduced consumption of water and steam for cleaning and sterilization
Why did the solid waste disposal needs of the single-use technologies outweigh those of the stainless steel plant?
Lower water and steam consumption of single-use technologies
Which technology required a significant amount of water and steam for cleaning and sterilization operations?
Stainless steel technology
What factor was mentioned as outweighing the solid waste disposal needs of the single-use technologies in the analysis?
Water and steam requirements
In the analysis, what aspect made the environmental burden higher for conventional stainless steel technology?
Cleaning and sterilizing water and steam requirements
Which detergent has been widely used for viral inactivation but can degrade to an endocrine-disrupting alkylphenol after discharge?
Triton X-100
What type of processes often have less environmental impact than perfusion processes due to consuming less water?
Fed-batch processes
Which detergent is mentioned as an alternative to Triton X-100, being much less ecotoxic and equally effective at viral inactivation?
LDAO
What is highlighted in the text as needing further evaluation from a sustainability viewpoint regarding biopharmaceutical manufacture?
Impact of biopharmaceutical manufacture
What is a potential environmental concern associated with the detergent Triton X-100 mentioned in the text?
It degrades into an endocrine-disrupting substance after disposal
Why is LDAO mentioned as an alternative detergent in the text?
It degrades less in the environment than Triton X-100
What sets fed-batch processes apart from perfusion processes in terms of environmental impact?
Perfusion processes consume more water
What kind of evaluation does the text suggest is needed for biopharmaceutical manufacture?
Sustainability viewpoint assessment
Which detergent is most likely to be considered more sustainable based on the information provided?
LDAO
Study Notes
Monoclonal Antibody Production
- A life-cycle analysis of a monoclonal antibody (mAb) produced by fed-batch cell culture was conducted, comparing conventional stainless steel and single-use technologies.
- Single-use technologies have a lower environmental burden across different scales.
Water and Steam Requirements
- The stainless steel plant requires a significant amount of water and steam for cleaning and sterilization operations.
- These requirements outweigh the solid waste disposal needs of single-use technologies.
Cell Culture Processes
- Fed-batch processes have less environmental impact than perfusion processes, which consume more water.
Viral Inactivation
- The detergent Triton X-100 has been widely used for viral inactivation, but it can degrade to an endocrine-disrupting alkylphenol after discharge.
- An alternative detergent, LDAO (lauryldimethylamine-N-oxide), is much less ecotoxic and just as effective at inactivating viruses.
Sustainability in Biopharmaceutical Manufacture
- Much more work is needed to evaluate the impact of biopharmaceutical manufacture from a sustainability viewpoint.
Test your knowledge on a detailed life-cycle analysis of a monoclonal antibody (mAb) produced using fed-batch cell culture. Explore the comparison between conventional stainless steel and single-use technologies for mAb production and their environmental impacts.
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