Late Phase API Development

Home Custom API development & API Manufacturing Late Phase API Development

Seqens is a world leader in pharmaceutical synthesis, capable of providing full CMC support to prepare for phase III clinical trials and drug registration globally in total compliance with the strictest regulatory, quality and EHS standards.
Our global R&D team in Porcheville, Paris, France and Newburyport, MA, USA will provide API cGMP services including:

Our services

  • Quality by design methodology
  • Carry over studies
  • Analytical validation
  • Crystallization studies
  • Process validation
  • Kilo-scale, pilot scale or multi-ton scale manufacturing to support phase III or launch
  • Special technologies like cryogenic or very high pressure capabilities
  • Special containment for highly potent APIs down to 100 ng/m3
  • Quality Assurance with a network of 6 cGMP/ FDA inspected sites in Europe and the United States
  • Back integration of critical intermediates or RSMs for supply security
  • Regulatory support and filings

Our locations

Porcheville

France
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Address ZI de Limay 2, 8 Rue de Rouen
78440 Porcheville
Phone +33 1 34 79 57 00
Market Pharmaceutical, Specialty Ingredients & Cosmetics
Mail 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 expertis

Last inspection: ANSM  October 2018

Certification: cGMP

 

Number of scientists: 110

 

Other: Ecosystem Pharma with integrated services

 

Devens

United States
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Address 88 Jackson Road, Building 649
MA 01434 Devens
Business Line R&D center
Phone (978) 772 2111
Market Pharmaceutical
Mail Accueil@seqens.com
More information

Lab surface: 1 000 m²

Capabilities:

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

Number of scientists: 30

 

Newburyport

United States
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Address 9 Opportunity Way
MA 01950 Newburyport
Business Line Custom Early Phase Pharmaceutical
Phone (978) 462 5555
Market Pharmaceutical
Mail Early Stage: derek.richards@seqens.com
Custom Manufacturing: don.laferle@seqens.com
Proprietary API: laurent.alexandre@seqens.com
More information

Surface: 5, 600 m²

Lab surface: 460 m²

Capabilities:

  • Process Research – Custom synthesis & synthetic route evlaution from g – kg for API’s or intermediates
  • Process Development – Custom synthesis from kg – metric tons
  • cGMP Small Molecule API Manufacturing (Phase 1, Phase 2, Phase 3, Commerical)
  • cGMP Medical Grade Polymers, Analytical Method Development

Flagship technologies: 

  • Controlled Substances
  • Cryogenic Chemistry -90°C
  • Lyophilization, Small/Large Scale Chromatography
  • Tangential Flow Filtration

Last inspection: July 2018 FDA Inspection

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