What is Process Development Stage?

Question

Accepted Answer

1. Literature research, patent evaluation report.

(1) Gather as much relevant publicly available information as possible.
(2) Design multiple possible synthesis routes.
(3) Evaluate potential intellectual property risks associated with each synthesis route.

2. Select a synthesis route and design reactions

(1) Finalize the design of each reaction step, evaluating profiles, impurity spectra, yield, and quality based on accumulated knowledge.
(2) Finalize post-treatment designs, including quenching, purification, filtration, and drying.
(3) RFT (Right First Time).

3. Process optimization.

(1) Compare pre- and post-optimization results, identifying "key process points.""
(2) Drafting of preliminary quality standards for starting materials and intermediates.

4. Impurity spectrum study.

(1) A comprehensive study is not required.
(2) There should be an overview of the major impurities.

5. Analysis of the reaction mechanisms.

(1) Analyze the reaction mechanism of each step to control side reactions.
(2) Optimize conditions favoring primary reaction.