Identify the correct facts about downstream processing.
(A) The processes include separation and purification.
(B) The product has to be formulated with suitable preservatives.
(C) The prepared formulation does not require clinical trials as in case of drugs.
(D) Strict quality control testing for each product is also required.
Choose the correct answer from the options given below.
Answer & explanation
Correct answer: option 2
The correct answer is Option (2) → (A), (B) and (D) only
(A) The processes include separation and purification. Correct. After the product is made in the bioreactor, it is mixed with cells and the medium. It must be separated and purified before it can be sold.
(B) The product has to be formulated with suitable preservatives. Correct. Preservatives keep the product from spoiling while it is kept and sold.
(C) The prepared formulation does not require clinical trials as in case of drugs. Incorrect. The formulation does have to undergo thorough clinical trials, as drugs do. The word “not” makes this statement wrong.
(D) Strict quality control testing for each product is also required. Correct. Every product is tested strictly for quality to make sure it is safe and works.
NCERT Extract:
Downstream Processing – “After completion of the biosynthetic stage, the product has to be subjected through a series of processes before it is ready for marketing as a finished product. The processes include separation and purification, which are collectively referred to as downstream processing. The product has to be formulated with suitable preservatives. Such formulation has to undergo thorough clinical trials as in case of drugs. Strict quality control testing for each product is also required.”