LAXAI offers exceptional process development capabilities that cater to our clients’ drug substance production needs in various stages of preclinical and clinical development. We use cutting-edge technologies to meet the growing demand for complex small-scale drug substance manufacturing. Our product offerings include key starting materials (KSMs) of non-GMP/GMP grade, advanced intermediates, and active pharmaceutical ingredients (APIs) in the required amounts, ranging from laboratory scales of one kilogram to industrial size.
We prioritize the production of drug substances that comply with the quality and purity standards established by regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure drug safety and efficacy. Drug substances undergo a comprehensive process that includes research and development, synthesis or extraction, purification, and characterization. Once the drug substance is developed and characterized, the drug product may require additional formulation and testing before it can be commercialized.
Infrastructure and Instrumentation:
- Reaction calorimeter (RC1e)
- Accelerating rate calorimeter (ARC)
- Differential scanning calorimeter (DSC)
- Thermal screening unit (TSU)
- Rapid screening unit (RSD)