Process Development & Scale Up

Scale Up Routes

Key Organics has supported many drug discovery programs, from hit validation to preclinical studies. We have particular expertise in the scale-up of synthetic routes to prepare multigram quantities of a lead compound for further studies. As many of our customers work to tight deadlines, we seek to optimise the efficiency of a scale-up route by reducing the number of steps and finding alternatives to chromatographic purification. Our chemists work closely with our in-house analytical team to ensure that final compounds meet or exceed the purity specification required by the customer, we can also provide SDS, BSE/TSE, GMO statements as needed by the client.

We have in house experience of synthesizing various salts of the desired compound to aid salt screening and polymorphism studies.

Our Capabilities Include:

Process Chemistry R&D to deliver robust routes
Scale-up of intermediates and final compounds (Kg scale)
Synthesis of development quantities of intermediates and of final compounds
Full reaction profiling
Production of the necessary documentation to assist the transition into GMP manufacture
Procurement

Drug Discovery Process Map

Compound Storage and Stability Testing

Using our storage space and facilities in the UK, we are ready to store your powder and liquid samples, format them on demand as required and distribute them to your site locations around the world. This service eliminates the need to have an organized compound repository on site while keeping your libraries easily accessible. Our storage conditions range from storage at ambient temperature to a cooled and refrigerated environment. We can also perform regular QC checks to monitor compound integrity during storage and provide valuable stability data.

I have been extremely impressed by Key Organics’ professionalism and candor during the separate multi-gram re-synthesis and route development project carried out recently. In particular, Key communicated clearly and rapidly with me when any obstacles to project delivery were encountered. Their swift and frank communication gave us time to jointly devise solutions which ensured that objectives were achieved while working to tight deadlines. Key’s ability to formulate innovative routes to important organic compounds is also the first rate. In this regard, they dramatically improved the availability of one of our crucial intermediates by developing some neat chemistry that relied upon unconventional thinking”

Our current suite of equipment features:

“Over four years and two different programs Key Organics have delivered for us right from the start. From inital engagement through to shipping and delivery it has been seamless. The expert chemists at Key Organics have delivered high quality material and data, rigorous process development and creative solutions to the inevitable problems that arise. Last-minute requests and the all too frequent changes in scope have been accommodated without fuss. While the chemistry has been exemplary the innovative solutions extend beyond the lab. A recent project would not have got internal approval without creativity, flexibility and input from their BD.

In one project I am particularly pleased about, the process development and scale up work, carried out by Key Organics, on a critical component from our crude discovery route enabled them to provide material we simply didn’t have the internal capacity to deliver; this fed directly into the supply chain for our phase 1 program.

The first-class communication, discussions and the thorough and detailed repoerting, which is essential when you’re on the other side of the world, has made my life that much easier. My confidence in Key Organics is the same as if they were in my own lab down the hall and I will be using Key Organics again and would do so more if I were able!”