• Your Product, Our Experience. It’s a good connection.

  Chemical process development and process understanding is fundamental to producing small molecule Active Pharmaceutical Ingredients (APIs) / Drug Substances (DS).

  The essence of every medicine is an Active Pharmaceutical Ingredient (API) or Drug Substance (DS).

  Allotrope Scientific Ltd specialises in chemical process design and the development of small molecule drug substances, intermediates and chemical products.

  

  Process Chemistry is not taught, it is a mindset, augmented by process understanding and years of industrial experience.

  Designing the conversion of a synthetic route, used to make milligram or gram quantities of a molecule, into a scalable process that consistently manufactures multi-kilogram and tonne quantities is complex. A lot of aspects need to be connected and understood. It’s a symphony of attention to detail, creativity and innovation.

  In pharmaceutical setting, chemical development, and understanding, is an integral part of Chemistry, Manufacturing and Controls (CMC) activities. Regulatory authorities require CMC submissions to validate the process quality.

  Though CMC guidelines remain the same, no two APIs are the same. The chemical process design, development and understanding, must be tailored to each drug substance or API.

  Our experts have extensive experience, along with a proven creative and innovative mindset in developing chemical processes for a variety of small molecules, from route scouting to scale-up and validation. With great attention to detail and broad experience in outsourced drug substance development, we offer a wide range of process chemistry, chemical development and drug substance CMC services, bespoke to your needs.

email: urvish.pandya@allotrope.tech Telephone: +44 (0)7947 942 709