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 !
Surface: 40, 000 m²
Lab surface: 2, 000 m²
- 6 kilo-labs
- 2 cGMP pilot plants with 11 multipurpose reactors from 100 L to 2, 800 L (total capacity of 12 m³)
- Temperature range: -15/+150°C (hastelloy reactor: -80/+200°C)
- 3 finishing rooms (agitated filter dryers, filters, dryers, milling and sieving equipments)
- Crystallization expertise and technologiesd(salt, co-crystal and polymorph screenings, process development)
- Process Safety expertise and tecnologies
- Flow chemistry for fine chemicals
- Potent API process development
- Genotoxic Impurities
- Issue Management
- Generic A.P.I Solid state expertise
Last inspection: ANSM October 2018
Number of scientists: 110
Other: Ecosystem Pharma with integrated services
Boston'Lab (Devens)United States
MA 01434 Devens
- 10,000 sq. ft. facility with 6 laboratories that house 28 hoods.
- 30 person staff, ¾ PhD’s
- 5 kilo lab hoods
- Glassware from ml to 100 liter jacketed glass vessels
- 20 and 50 liter rotovaps
- Various filtration equipment
- Temperature ranges -78 – 240°C
- Thin film evaporation
- Flash chromatography
- Prep chromatography
- High pressure par reactors