Pre-Clinical You want a creative and reliable partner in the pursuit of your clinical candidate. We support your endeavors to prepare non-GMP API in gram quantities and beyond. Access to your first kilogram is an exciting milestone, and together, we can help you achieve it.
Our team is process oriented, developing routes that are both scaleable and efficient. Our Devens facility is equipped with 32 kilo labs capable of operating up to 100 L vessels for both non-potent and highly-potent compounds. Our goal is to help you accelerate your candidates into the clinic. Transitioning from a med chem environment to a chemical development lab involves a paradigm shift. We understand that as scale increases, process safety is of utmost importance to you. Refinement of reagents and conditions to eliminate safety hazards is just the beginning of how we can help you move your process into the plant.  Using our unique separations capabilities, we can execute chromatography on immature processes. In addition, our catalytic process capabilities can telescope your synthesis, and our salt selection studies will identify viable API forms.
Our analytical scientists work closely with our process research teams to monitor reactions and to develop analytical methods necessary for the complete characterization of materials. Additional analytical activities at this phase include impurity profiling and identification, initial methods qualification, certification of reference standards, and authoring of the Chemistry and Manufacturing Controls (CMC) section of your IND filing.
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