Drug Substance
Drug substance development and production is the foundation on which pharmaceutical product development is built. The ability to make consistent (identity and quality) drug substance batches is key to turning a compound that shows promise in the laboratory to plant-scale product that is effective and safe while meeting regulatory needs. Biopin-Aambal Life Sciences provides comprehensive drug substance development services from gram-scale to ton-scale.
Analytical chemistry and development
- Develop analytical methods to support the development of drug substances and complex bulk drug products.
- We have special expertise in detecting, qualifying and quantifying impurities in drug substances and tracking these back to their point of origin.
- All analytical work is performed using state-of-the-art, GMP qualified, equipment and facilities.
Process and scale-up chemistry
- Process chemistry services for active pharmaceutical ingredients (APIs) and their intermediates
- Process chemistry services for clinical drug candidates (NCEs)and their intermediates
- Impurity and metabolic profiling of APIs and new drug product formulations
- Purification and crystallization
- Salt screening and polymorph studies for clinical drug candidates and APIs
- Process and scale-up chemistry service for rare and complex molecules, fine chemicals and new starting materials
Green chemistry
We provide sustainable chemistry services that apply green and engineering chemistry principles.
- Prepare safe and environment-benign synthetic and scale-up processes in the APIs and clinical drug candidate production.
- Prepare safe and environment-benign synthetic and scale-up processes in the starting materials, raw materials and intermediates for the production of APIs and clinical drug candidates, agrochemicals and other chemicals.
- Use safe and environment-benign synthetic process and scale-up in the preparation of fine and rare chemical, starting and raw materials for the application of discovery, focused and applied chemistry research.
Manufacturing and stability
- Our manufacturing partners offer a comprehensive ranges of services designed to support the rapid scale up and manufacture of new molecules.
- We also offer in-house manufacturing in small batches using state of the art facilities.
- We have the capabilities to evaluate drug substance stability at various temperatures and humidity levels as requested by the regulatory agencies.
