GMP API Manufacturing & Organic Synthesis
One of the key capabilities that keeps your drug development programs out in front is a unified suite of services combining the capabilities of a modern medicinal chemistry research laboratory – from R&D to formulation to scale-up – with capabilities of an organization that can coordinate and execute preclinical, clinical and a full range of bioanalytical services.
At Frontage, a talented group of organic chemists has the background to optimize the synthetic chemistry routes required to deliver high-purity APIs. With significant experience in the development, scale-up and small-scale production of APIs and advanced intermediates, our organic chemistry team can assist in all phases of development, from small preclinical batches to commercial quantities.
The Frontage chemistry team is especially well qualified in impurity identification and separation of impurities in APIs, as well as synthesis of reference standards and drug metabolites. Frontage chemists handle milligram scale reactions, small-scale purification and isolation in milligram quantities but have the knowledge and equipment to scale up to our cGMP kilo lab. Frontage is additionally affiliated with a network of GMP and intermediate manufacturing facilities in Europe, India and China to support scale-up and commercialization.
Services & Capabilities
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Reference standards
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Impurity standards
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Analytical marker compounds
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Metabolite synthesis
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Process design and scale-up
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DMF support
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Technical transfer
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Sourcing of intermediates and APIs
Equipment
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20 liter glass jacketed reactor (-20°C to 230°C)
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75 liter glass jacketed reactor (-70°C to 230°C)
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GMP 2 liter and 20 liter rotary evaporators
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20 liter glass filtration unit
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2.5 liter freeze dryer
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Automated flash chromatography
