IQsynthesis has custom synthesis capabilities to manufacture cGMP supplies of active pharmaceutical ingredients (APIs). We can also synthesize advanced intermediates to support lead optimization programs. IQsynthesis can develop a custom synthetic process for APIs or optimize an existing process as provided by the client.

All cGMP APIs are manufactured in environmentally monitored clean room suites equipped with separate air-handling systems and HEPA-filtered air under negative pressure to assure no cross-contamination.

Synthesis activities are complemented with analytical support and characterization capabilities to assure product identity and purity. Our analytical team also provides in-process testing, reaction end-point monitoring and identification of impurities and byproducts.

Service/Capabilities

• Scale-up and process optimization
• Reference standards from milligram scale to multi-kilo scale
• Marker compounds
• Dedicated glassware and equipment
• Peptides and conjugated large molecules
• Building block chemistries
• Medicinal chemistry libraries
• Novel route design
• Controlled substances
• Literature synthesis
• Preparative chromatography
• Potent cytotoxic compounds
• CMC regulatory support