Monoclonal Antibody Production Analysis Quiz
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Questions and Answers

What was the primary reason for the lower environmental burden of the single-use process over the stainless steel process?

  • Easier scalability of the single-use process
  • Reduced consumption of water and steam for cleaning and sterilization (correct)
  • Higher production capacity of the single-use technology
  • Fewer regulatory requirements for single-use technologies

Why did the solid waste disposal needs of the single-use technologies outweigh those of the stainless steel plant?

  • Higher environmental regulations for stainless steel plants
  • Challenges in scalability for stainless steel plants
  • Ease of cleaning and sterilization in single-use technologies
  • Lower water and steam consumption of single-use technologies (correct)

Which technology required a significant amount of water and steam for cleaning and sterilization operations?

  • Stainless steel technology (correct)
  • Both technologies equally
  • Single-use technology
  • Neither technology required water or steam

What factor was mentioned as outweighing the solid waste disposal needs of the single-use technologies in the analysis?

<p>Water and steam requirements (B)</p> Signup and view all the answers

In the analysis, what aspect made the environmental burden higher for conventional stainless steel technology?

<p>Cleaning and sterilizing water and steam requirements (B)</p> Signup and view all the answers

Which detergent has been widely used for viral inactivation but can degrade to an endocrine-disrupting alkylphenol after discharge?

<p>Triton X-100 (C)</p> Signup and view all the answers

What type of processes often have less environmental impact than perfusion processes due to consuming less water?

<p>Fed-batch processes (C)</p> Signup and view all the answers

Which detergent is mentioned as an alternative to Triton X-100, being much less ecotoxic and equally effective at viral inactivation?

<p>LDAO (A)</p> Signup and view all the answers

What is highlighted in the text as needing further evaluation from a sustainability viewpoint regarding biopharmaceutical manufacture?

<p>Impact of biopharmaceutical manufacture (D)</p> Signup and view all the answers

What is a potential environmental concern associated with the detergent Triton X-100 mentioned in the text?

<p>It degrades into an endocrine-disrupting substance after disposal (D)</p> Signup and view all the answers

Why is LDAO mentioned as an alternative detergent in the text?

<p>It degrades less in the environment than Triton X-100 (B)</p> Signup and view all the answers

What sets fed-batch processes apart from perfusion processes in terms of environmental impact?

<p>Perfusion processes consume more water (B)</p> Signup and view all the answers

What kind of evaluation does the text suggest is needed for biopharmaceutical manufacture?

<p>Sustainability viewpoint assessment (D)</p> Signup and view all the answers

Which detergent is most likely to be considered more sustainable based on the information provided?

<p>LDAO (B)</p> Signup and view all the answers

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.

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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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