Chemical Development
SAI has an experienced team of over 110 process chemists who can advance our client's drug candidates into initial scale-up quantities that will support pre-clinical studies. Furthermore, the experienced team can further optimize the synthetic process into a commercially viable route to produce sufficient GMP materials for clinical trials and beyond. Sai’s process chemistry team works closely with the medicinal chemists to ensure a seamless and efficient transfer of the entire synthetic chemistry knowledge around the lead compounds into the process development and optimization process. Our process chemists work in well-equipped labs with state-of-the-art instruments to enable rapid solutions to synthetic problems with the aid of on-line chemical literature access for efficient information retrieval. We have a suite of kilo labs in which we can support preparation of API for clients’ IND enabling toxicology studies and/or provide synthetic intermediates to meet our clients’ needs.
The chemical development services offered by Sai include:
- Scouting new routes of synthesis
- Optimization of reaction conditions for existing routes
- Scale up for pre-clinical studies
- Developing analytical methods for characterization of intermediates & final compounds
- Salt selection & polymorph screening
Manufacturing
Sai has two FDA approved manufacturing facilities and a strong track record in supporting both the manufacture of clinical trial materials and commercial products. The plants have a total installed reactor capacity of 47 cubic meters consisting of glass-lined and stainless-steel reactors ranging in size from 50L to 3,000L. We can support a range of reactions with temperature from -80C to 180C as well as large-scale hydrogenation and separation/purification. The manufacturing teams work closely with the process and analytical teams to ensure there are constant improvements in the synthetic process along with robust analytical methods. Our QA/QC teams can provide comprehensive regulatory support and has successfully overseen two internal FDA audits and supported over 90 of our clients’ GMP audits in the last three years.
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