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
Newburyport
United States
Address
9 Opportunity Way
MA 01950 Newburyport
MA 01950 Newburyport
Business Line
Custom Early Phase Pharmaceutical
Phone
(978) 462 5555
Market
Pharmaceutical
Mail
derek.richards@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
Porcheville
France
Address
ZI de Limay 2, 8 Rue de Rouen
78440 Porcheville
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
Address
88 Jackson Road, Building 649
MA 01434 Devens
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