SAI Advantium | Welcome

Process Chemistry & Scale-Up

Sai Advantium has extensive experience and expertise in taking our clients’ drug candidates through initial scale-up activities to support pre-clinical studies, and onwards into pilot manufacture for clinical trials. Our dedicated Process Chemistry team works closely with the Medicinal Chemistry group to provide a seamless transfer of a project along the drug development pipeline.

Our Process Chemistry group is geared towards:

Support for later-stage Medicinal Chemistry
Process R&D
Non-GMP and cGMP synthesis for pre-clinical and early clinical activities
NCEs and APIs for research and development

Specifically:

Process development and Process optimization
Route scouting
Preparation of key intermediates
Clinical Trial Supply
Synthesis of standards for reference
Analytical method development and method validation
Impurity profiling and structure elucidation
Stability studies
Lab assurance batches
Pilot batches and Process Validation
Stability Studies under ICH guidelines

cGMP Manufacturing

Sai Advantium has the capability to supply GMP APIs and advanced intermediates to support all stages of development from preclinical studies through clinical trials to validation and commercial launch. We have a team of over 75 process chemists with extensive experience in early stage process development and scale-up. Our process and medicinal chemistry groups work in an integrated fashion to facilitate rapid delivery of clinical materials. Our equipment and operational capabilities include:

Glass-lined and Stainless Steel Reactors ranging in sizes from 25L to 2,000L.
Ability to handle temperature ranges from -80oC to +200oC
Hydrogenation up to 1,000L capacity at 200PSI
Large scale column chromatography
Dryers and Blenders
Class 100,000 clean-room facilities for API handling
On-site utilities (generator, boiler and chillers)

Communication & Project Management

Regular communication is crucial to successful drug development projects. Sai Advantium teams strive to become true extensions of client teams, communicating progress, and developing common strategies for resolving technical and logistical issues via direct communication, that is data and need driven. We use the latest technologies to provide our clients with written reports and the capability of conducting meetings by teleconference or online.