Multi-step reaction to deliver a clinical study drug precursor for GMP production

Case study

Custom Synthesis

The Challenge

Demonstrating our capability and expertise, AF ChemPharm took on the challenge of producing 1kg of a precursor for GMP production of a 12-step drug candidate required for a clinical study for a medium-size biotech company.

We developed a reaction to synthesise two moieties in parallel to be coupled in a final step. For coupling to be successful, it was essential to maintain chiral integrity in both arms of the process and the final reaction.

The Approach

Our approach is to fully understand the complexity of the customer’s problem, carry out the work on small scale to demonstrate proof-of-concept, give the customer confidence in our work and approach of achieving the high standard they require regarding purity, integrity of the stereochemistry and delivery time.

The Results

This gave us, and more importantly the customer, a confident platform to scale up to kilogram quantities, keeping the purity, quality and required stereochemistry in the delivery of the bulk material on time for their scheduled GMP production.

Contact the team at AF ChemPharm and let us solve your chemistry challenges.