API Manufacturing

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Apertus offers medicinal and synthetic organic chemistry solutions on milligram to kilogram scale. Our chemistry team brings experience from previous employment in the fine chemical, pharma and biotech industries and can help you at any stage in your development process. Our style is highly collaborative, stressing close contact, open communication and full disclosure of progress – both accomplishments and roadblocks/issues, to enable rapid decision making and project success.

Apertus can help with your API manufacturing needs by:

  • Synthesizing intermediates, drug substances or building blocks on mg to kilogram scale
  • Providing route selection and optimization services
  • cGMP synthesis of targets for pre-clinical and clinical studies
  • Documenting process design work for regulatory filings
  • Performing validation batches and writing associated validation reports
  • Conducting stability and forced degradation studies
  • Developing stability-indicating analytical methods
  • Identifying and synthesizing process impurities and degradants
  • Manufacturing your NME for delivery to your selected formulator
  • Providing tech transfer support if a larger manufacturing facility is required

In addition Apertus can help in specialty areas such as:

  • Potent compound synthesis
  • Controlled substance manufacturing (Schedule II-V)
  • Synthesis of synthetic and semi-synthetic opioids
  • Development of process chromatography or batch crystallization methods

Project API Examples:

 

Case Study

Project Objective: Reduce alpha-beta unsaturated ketones (ABUKs) in oxymorphone and oxycodone.

Discussion: A variety of methods exist to reduce ABUKs in oxycodone and oxymorphone. A novel method developed in-house was found to reduce the ABUK levels to nearly undetectable amounts by single ion monitoring mass spectrometry. The method involved isolation of an intermediate that was efficiently hydrogenated to the target API followed by a workup that proved efficient at removing traces of ABUK. In addition, the isolated products were bright white solids.

Outcome: A novel method to reduce ABUKs in oxymorphone and oxycodone was developed that yielded white, low ABUK product.

Patent pending.