Service Ecosystem
GMP/NON-GMP ManufacturingDuring the manufacturing phase, protocols for large scale production are setup and validated, first batches are prepared and tested, both in non GMP as well as GMP conditions.
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Non-gmp
gmp
Process Research & Development
This phase aims to provide a safe and scalable route to small molecule API synthesis whilst generating reproducible quality material. This creates a sound basis for later phase development with more detailed specifications and impurity synthesis for the process validation.
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GMP Manufacturing
Prior to GMP manufacture, the process outlines produced in development are converted into step-by-step instructions in a Process Record Sheet (PRS), the analytical chemistry methods and specification tables are converted into monographs describing the analytical work required to control the process.
Any deviations are documented in line with quality procedures through non-conformance reports (NCRs) and out of specification (OOS) reports. Corrective action and preventative action plans (CAPA) can then be put in place when required and are documented through our change control (CC) procedure.
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Custom synthesis services (from mg to Kg)
Scale up manufacturing based on synthetic organic chemistry. Ultra Performance Flash Purification for mg production and thermostatted lab reactor for kilos. Modern analytical instruments allow to perform detailed analysis and structural characterization (HPLC, GC, UV-Vis, NMR, HRMS).
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Analytical Method Development
Methods used to measure purity and potency of small molecule with high quality and suitable for a cGMP synthesis.
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