Seqens provides active pharmaceutical ingredient (API) and drug substance development services to 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)

Our locations

Address PCAS, ZI de Limay 2, 8 Rue de Rouen
78440 Porcheville
Phone +33 1 34 79 57 00
Market Pharmaceutical, Specialty Ingredients & Cosmetics
Email ContactSeqensPCV@seqens.com
More information

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 expertise

Last inspection: ANSM  October 2018

Certification: GMP

Number of scientists: 110

Other: Ecosystem Pharma with integrated services

Address PCI Synthesis, 88 Jackson Road, Building 649
MA 01434 Devens
Phone (978) 772 2111
Market Pharmaceutical
Email Accueil@seqens.com
More information

Lab surface: 1, 000 m²

Capabilities:

  • Controlled substances (Schedule II-V)
  • 5 Kilo-Labs

Number of scientists: 30