Our chemistry team brings experience from the fine chemical, pharma and biotech industries and can help you at any stage in your development process. Our style is highly collaborative, emphasizing 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:

• Sourcing and vetting overseas API suppliers
• Synthesizing intermediates, drug substances or building blocks on mg to kg 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 NCE 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