Within the pharmaceutical industry, Process Research and Development (R&D) traditionally focused on stabilizing chemical processes. Some 40 years ago, there was insufficient emphasis on crucial scale-up considerations such as safety, waste management, and energy efficiency. The industry rationalized its practices by arguing that the life-saving benefits of pharmaceutical products significantly outweighed the environmental impact of the waste produced. Consequently, pharma emerged as one of the least efficient sectors in terms of waste generation per unit of product manufactured. Moreover, once a less than ideal process is scaled to commercial production and embedded in subsequent regulatory filings, opting for an alternative becomes a costly and time-consuming endeavor due to regulatory hurdles.
AAPharmaSyn is a process chemistry CRO providing pharmaceutical process research and development services for drug substances and APIs, from route scouting and process development through scale-up and commercialization.
AAPharmaSyn has been the pioneer in helping its clients to evaluate and preemptively address process hurdle both in generics and proprietary APIs. We offer comprehensive pharmaceutical process research and development services for drug substance that include
Process Development and optimization
Analytical Method Development and Validation
Lab-scale Process Evaluation
Parametric Studies (DOE)
Analytical Method Transfer
Specifications Development
Reference Standard Qualification
Route Scouting (i.e. process research)
Process Development and optimization
Analytical Method Development and Validation
Lab-scale Process Evaluation
Parametric Studies (DOE)
Analytical Method Transfer
Specifications Development
Reference Standard Qualification
Route Scouting (i.e. process research)
As we conduct Route scouting activities, we are guided by the best industry practices summarized within 9 principles of process chemistry.