Question

Many biologics are manufactured using living cells. What is not a concern of the process development group?

-Possible loss of the recombinant DNA in the production cells
-Yield of formulated product through the purification process
-Increasing the number of patients who will use the drug
-Product yield in bioreactor
-Genetic stability or instability of the cells

Answer 1

The concern that is not related to the process development group is 3) increasing the number of patients who will use the drug. The process development group focuses on factors such as possible loss of recombinant DNA in the production cells.

Step-by-step explanation:

The concern that is not related to the process development group is 3) increasing the number of patients who will use the drug.

The process development group focuses on factors such as possible loss of recombinant DNA in the production cells, yield of formulated product through the purification process, product yield in the bioreactor, and genetic stability or instability of the cells.

The number of patients who will use the drug is a concern of marketing and sales, rather than process development.