About Us

About our Process Research

Process R&D 3 stages:

1. Process research
2. Process development
3. Scale-up in Kilo-lab or Pilot Plant

The way of working within our team, This way of working emphasizes:
1. Process chemists should be familiar with factory equipments, and use this knowledge to guide our process development.
2. Crystallization is an important part of a good process. We should rely more on crystallization to purify the product, and reduce the tendency of using slurry and chromatography.
3. The use test should mimic factory production conditions to reveal early on whether there is any problem in our process. Rotary evaporation and magnetic stirring are banned from using in the use test. Both are also discouraged to use during process development.
4. We should Excel spreadsheet to monitor the impurity profile and the movement of the impurities during the reactions.
5. We should increase our working efficiency by working smarter not by working harder.

FDA guidelines
•   Q8(R1) Pharmaceutical Development Revision 1, 9-June-2009
    QbD (Quality by design)
    DoE (design of experiments)
•   CQA (critical quality attribute)
•   CPP (critical process parameter)
•   CIPC (critical in-process control)
Knowledge from other public domain
•    Learn and confirm – Some big pharma companies website
•   “Bottom-up” – Bristol-Myers-Squibb

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