case study

Olon USA 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 USA apart.

case study

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 USA can help you. Please contact us if we may further discuss an interest.

Chemical Development Study

Case Studies

Olon USA 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.

Process Development and Scale Up – Challenging Chemistry

Introduction and Background

A large Pharma client had previously contracted with an overseas CDMO company to create a scalable process for the production of a small molecule API.  This molecule presented many production challenges due to its chirality and substituents being attached in a diastereoselective manner.  After more than a year of effort, a scalable process was still unavailable.  As a result, the client requested that Olon USA create a scalable production process and produce a 2 kg and 10 kg batch in the pilot plant.

fornula molecola
molecule

Impurity Preparation Capabilities – Example

Introduction and Background

 

A late-stage API isolated by a fermentation process required more than 10 impurities to be used as standards / markers.  Six of them required synthesis and purification using reverse phase flash chromatography and preparative HPLC. 

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