Grade, Range, and Format: The Importance of Bioprocessing Reagents

摘要

In pharmaceutical and biochemical manufacturing processes, the emphasis is on knowable quality levels, defined components, and predictable, repeatable yields and products. This underlines the importance of reliable specification and quality claims, whether they point to cGMP, molecular biology grade, high purity, or simpler grades. The point is to be what they are claimed to be. Naturally, it is not a question of the highest purity possible, but rather the highest purity necessary at a cost that makes sense. It's all part of driving high-level processes to reliable endpoints, of a sustainable manufacturing scenario that reduces costly repurifications, workloads, and QC failures.