Which of the following is NOT listed as a reason some lab-scale DNA precipitation methods are UNSUITABLE for industrial pharmaceutical manufacture?

Question

BlackTom AI · Accepted Answer

The correct answer is "Mixing and pumping limitations caused by increased viscosity at large scale" because the other three choices are standard, explicitly cited concerns when moving lab-scale DNA precipitation methods into industrial pharmaceutical manufacture.

Relevant knowledge points:
- Scaling lab protocols to industrial GMP manufacture raises economic, regulatory, and safety constraints.
- Commonly cited unsuitability factors include raw material cost (percent cost impact at large volumes), health/safety concerns (toxic or flammable reagents), and availability of appropriate chemical grades (pharma/USP-grade reagents required for drug manufacture).

Step-by-step reasoning:
1. Raw material cost: At lab scale, buying research-grade reagents in small quantities can be inexpensive; at industrial scale, the per-batch reagent cost becomes a major driver of process feasibility. This is a standard reason methods are rejected.
2. Health/safety concerns: Many lab precipitation protocols use volatile organic solvents or hazardous salts. Industrial manufacture must mitigate worker exposure, explosion risk, waste handling, and environmental release—therefore safety is a primary listed concern.
3. Availability of appropriate chemical grade: Pharmaceutical products require reagents that meet impurity and certification standards. If a lab method depends on a reagent that is not available or is prohibitively expensive in GMP grade, the method is unsuitable.
4. Mixing and pumping limitations: While large-scale fluid handling and solids suspension can pose engineering challenges, this specific phrasing (increased viscosity causing mixing/pumping limitations) is not typically listed as a primary reason in the referenced list. Precipitation methods more often fail on cost, safety, and regulatory-chemical-grade grounds; mechanical issues like pumping can often be addressed by standard engineering solutions and are not cited as a categorical disqualifier in that context.

Why the other options are incorrect: Each of the three (raw material cost, health/safety concerns, availability of chemical grade) is a direct, commonly documented reason for unsuitability. They therefore are listed, unlike the mixing/pumping viscosity point.

Conclusion: Therefore the option not listed is "Mixing and pumping limitations caused by increased viscosity at large scale," which matches the provided correct answer.

Which of the following is NOT listed as a reason some lab-scale DNA precipitation methods are UNSUITABLE for industrial pharmaceutical manufacture?单项选择题

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