Early Phase API Development
Seqens supports emerging and large pharmaceutical customers, in human and animal health, with their small molecule early drug substance development needs through two main R&D locations in the regions of Boston and Paris
Our global R&D team in Porcheville, Paris, France and Devens, MA, USA, are experienced in providing API CMC (Chemistry, Manufacturing and Controls) requirements to meet your project needs, including:
SEQENS offers a wide range of Custom API Manufacturing services
Seqens supports emerging and large pharmaceutical customers, in human and animal health, with their small molecule early drug substance development needs through two main R&D locations in the regions of Boston and Paris.
Our global R&D team in Porcheville, Paris, France and Newburyport, MA, USA, are experienced in providing API CMC (Chemistry, Manufacturing and Controls) requirements to meet your project needs, including:
- Route selection
- Chemical process development including controlled substances
- Large scale chromatography
- Analytical development
- EHS assessments
- Solid state services including polymorphism evaluation
- API clinical supply using cGMP kilo-lab suites or pilot plants
- ICH stability studies
Our locations
Porcheville
France78440 Porcheville
Surface: 40 000 m²
Lab surface: 2 000 m²
Capabilities:
- 4 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)
Flagship technologies:
- 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 expertis
Last inspection: ANSM October 2018
Certification: cGMP
Number of scientists: 110
Other: Ecosystem Pharma with integrated services
Devens
United StatesMA 01434 Devens
Lab surface: 1 000 m²
Capabilities:
- Controlled substances (Schedule II-V)
- 5 Kilo-Labs
Number of scientists: 30