Early Phase development for pharmaceutical solutions

Seqens provides active pharmaceutical ingredient (API) and drug substance development services. We support emerging and large pharmaceutical customers in human and animal health with their pharmaceutical and biotechnology applications for complex, niche and small molecule programs through two main R&D locations in the regions of Boston and Paris.

Seqens’ Development team operates state of the art facilities to handle the most complex API development challenges. With a broad range of experience and knowledge of the latest technologies in organic synthesis, our chemists establish robust and economical routes for the synthesis of API’s.
Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications, and processing instructions.
The salt form and polymorph landscape are explored within our Solid-State Analysis teams and drive the development of the API isolation process.
Our global R&D team in Porcheville, Paris, France and Devens, MA, USA, are experienced in providing API CMC (Chemistry, Manufacturing and Controls) requirements, including IND-enabling projects, to meet your project needs, including:

• Development of new, scalable API route selection
• Route development
• Chemical process development including controlled substances
• Large scale preparative chromatography for impurity isolation
• Solid state services including polymorphism screening and salt selection
• Starting material and other raw materials sourcing and development
• Analytical development and method qualification
• Preliminary ICH stability profile
• Process Safety assessments
• API clinical supply using cGMP kilo-lab suites
• IND document preparation & review (CMC or DMF preparation)

Discover our late phase development programs !