case study
Olon Ricerca Bioscience has a wealth of experience in chemical development which support the process of moving drug candidates through the development pipeline, attaining desired chemical synthesis and regulatory compliance. We have a team of scientists that are experts in dealing with challenging chemistry or development concerns, are enthused by such challenges, and have a great track record in overcoming them. We believe this is a characteristic that sets Olon Ricerca Bioscience apart.
This section presents a sampling of case studies in the various areas of our business
Browse through them to gather an impression of how Olon Ricerca Bioscience can help you. Please contact us if we may further discuss an interest.
Chemical Development Study
Case Studies
Olon Ricerca Bioscience is your single-source solution for chemical development needs, providing a wide range of analytical chemistry, synthetic chemistry, engineering, and API manufacturing services. The following case studies demonstrate how we have helped clients meet specific challenges in chemical development.
Chemical Development & Toxicology Studies Supporting IND
Introduction & background
The client contracted Ricerca to conduct a series of biological evaluations of their compound including a critical 28-day toxicology study in dogs. Completion of the dog study controlled the IND filing date. The compound needed for these studies had been prepared by another CRO. This lot of compound could not be properly formulated for use in the animal studies. In addition, there was aconcern that the amount of compound available was too little to support the needed studies. As a consequence, the IND filing date was at risk.
Development, Scale-up & Manufacture of API Using 15 Step Process
Introduction & background
The first multi-kilogram lot (API development candidate for cognitive disorders) had been prepared by another CRO at the 20-gallon scale of operation. The processing was difficult and several scale-up problems were encountered. Expedited work-arounds were identified and implemented. The API output from the preparation was below the required amount.
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