API Process Development

To combat the increasing complexity in API synthesis, experience and expertise to identify the right method that can be used starting from the lab scale to pilot scale and hence plant scale is highly required.

At Esco Aster, we have the expertise for developing a robust and scalable process using continuous flow chemistry as well as modified batch process methods.

Capabilities

Optimization and Validation of Existing Synthetic Routes
Optimization and Validation of Existing Synthetic Routes
Optimization and validation of known/existing synthetic routes with the appropriate methodology (continous or batch or a combo method) which include feasibility studies of key reaction steps and proof of concept lot synthesis on gram scales
Development of Shorter Synthetic Routes
Development of Shorter Synthetic Routes
Design and Development of alternate, efficient and shorter synthetic routes and also development of IP protected novel synthetic routes
Enhanced Work-Up Protocols
Enhanced Work-Up Protocols
Development of efficient work-up procedures and effective isolation methods, reproducible purification protocols
Synthesis of API Impurities
Synthesis of API Impurities
Synthesis of API impurities and development of seperation procedures of impurities using chromatography and other methods
Synthesis of Advanced Stage Intermediates
Synthesis of Advanced Stage Intermediates
Synthesis and optimization of procedures for synthesis of Advance/Late stage intermediates required for APIs and Crop chemicals
Phosphoramidites, Special Monomers
Phosphoramidites, Special Monomers
Develop synthetic procedures for novel Phosphoramidites involved in Oligonucleotide synthesis and special monomers for Polymers
Analytical Method Development
Analytical Method Development
Analytical method development specific for each API and their impurities