Non-cGMP Custom Synthesis
Projects for custom synthesis may or may not have a defined synthetic route described in a technical package and can require milligrams to kilograms quantities of material. We provide rapid access to target structures that require multi-step organic syntheses. Custom synthesis projects often support drug discovery or early-stage development efforts.
Selected examples include:
- Route design, optimization and synthesis/scale-up of a structurally complex target designed from existing SAR data, for biological evaluation in support of a MedChem discovery program
- Isolation and structure determination of process impurities, degradants or metabolites for an API using LC/MS and chromatographic isolation coupled with advanced Nuclear Magnetic Resonance (NMR) technology
- Custom synthesis of identified or suspected process impurities, degradants or metabolites for an API to confirm the structure(s) or serve as a marker or reference standard for determination of relative response factors (RRF)
- Production of various quantities of material for GLP toxicology studies