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Responding to FDA Requirements = Time & Money

Accelerate Your Product Development: Custom Synthesis & Process Development

The graph below illustrates what we did for one customer in less than three months.

Synthesis Feature

Synthesis Support

• Custom Synthesis of New Molecules (mg to kg scale)
• Route Design for Your Proprietary Molecules
• Structural Identification of Metabolites and/or Degradants
• Synthesis of Analogues, Metabolites, and/or Degradants
• Synthesis of Stable Isotope-Labeled Compounds as Reference Standards

Manufacturing Process Development & Improvement

• Route Scouting
• Process Development & Scale-Up
• Technology Transfer
• Recommended Experts for the Following:
⋅ Clinical Manufacture
⋅ U.S. Patents
⋅ Preparation of Regulatory Filings

Woman Mixing Chemicals

Biomarker Synthesis

Drug Metabolite Identification & Synthesis

⋅ Isolate & Identify the Structures of Drug Metabolites
⋅ Synthesize Each Metabolite
⋅ Compare Properties of the Isolated & Synthetic Material

Drug Degradant Identification & Synthesis

⋅ Isolate & Identify the Structures of Drug Degradants
⋅ Synthesize Each Degradant
⋅ Specifically Label Reference Materials With Stable Isotopes for Rapid Identification by Mass Spectrometry

Labeling with Stable Isotopes

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