API Development and Production
Seqens has more than 50 years of experience in developing and producing high-quality APIs.
TRUSTED SUPPLIER of APIS
With 1 000/m3 of cGMP production capacity, 130 R&D chemists and seven pilot units providing first class R&D capabilities, and proprietary technology, such as biocatalysis, to develop unique processes, Seqens has the capacity and competence to develop your API project successfully, to scale up production as needed, and to handle regulatory filings at every stage and in all markets.
Seqens has an in-house IP team for the design of non-infringing patent process to assure the customer the freedom to operate on the target market at the desired launch. But our target is not only to be the first but also to last to be part of the long term success of the project, that’s why in addition to patent-free we develop cost competitive products by incorporating original technologies and working on the last array of chemistries where Seqens has a strong knowhow.
We offer a dependable manufacturing network of five cGMP plants in Europe and one in the United States, all of which have a strong track record dealing with the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) and the Pharmaceuticals, Medical Devices Agency (PMDA) in Japan and other international regulatory agencies.
More than 50 APIs have been successfully launched in the United States, Europe and Japan with consistently superior quality, reliability and customer service, and supported by regulatory documentation to meet the most stringent standards from local agencies.
In house back integration for starting API materials
Additionally, to minimize the impact of variability in the quality of raw materials on production timelines and regulatory approval, Seqens’ has several pre-GMP sites that provide supply security with back-integration of raw material and regulatory starting materials. Without having to depend on third parties, we can obtain advanced intermediates in the necessary quantities for your project, while also controlling cost of critical materials.
Multisite backup production of an API
Several GMP compliance production sites, Seqens can offer an additional level of supply security by offering the possibility of incorporating another site for the API production.
Our locations
Couterne
France61410 Couterne
Surface: 120, 000 m²
Capabilities: 190 m³ of ISO 9001 reactors and kilo-lab
Flagship technologies: Most standard organic synthesis reactions (large volumes)
Certifications: ISO 9001
Lahr
Germany77933 Lahr
Surface: 48 000 m²
Lab surface: 700 m²
Capabilities:
- Total reactor capacity: 92 m³
- Reaction vessels: 1 to 6 300 L; temperature -80°C to +250 °C
- Multi-purpose state of the art cGMP facilty: 4 independent, vertical integrated production trains 800 L train, 2 x 3 000 L trains plus 1 x 3 000 L low temperature hydrogenation reactor and 6 000 L train
- Classic two-floor layout Facility: 20 vessels with capacity between 800 and 6 000 L (glaslined and SS)
- Autoclaves (operational range up to 100 bar)
- Kilo-Lab: 3 reactors: 25 / 100 / 250 L
Flagship technologies:
- Hydrogenation
- Reductive amination
- Organometallic reactions
- Protected AADs (Aminoacid derivatives)
- Carbonylation & Hydroformylation
- Pressure aminolysis, other reactions under pressure
- Cryogenic chemistry
- Enantiopure synthesis
- Cyanation high volumes (NaCN) C-C coupling
- Reductions
- Halogenation
Last inspections:
- FDA 2018
- German Pharma Authority 2018
Certifications:
- GMP
- ISO 9001
- ISO 50001
Number of scientists: 25
Limay
France78520 Limay
Capabilities:
- 70 m³ of GMP reactors
- 100 L – 8 000 L vessels
Flagship technologies:
- Optical resolution
- Enzymatic hydrolysis
- Enantioselective reduction
- Low-temperature reactions (-80 °C)
- Specific reduction
- Hydrogenation (40 bar)
- Organomagnesium compounds
- Thin-layer distillation
EcoVadis CSR Rating: Gold Certification 2019
Last inspections :
- FDA 2018
- ANSM 2019
Aramon
France30390 Aramon
Capabilities:
- 100 m³ of GMP reactors
- 50 L – 10 000 L vessels
Flagship technologies:
- Organometallic chemistry
- Large-scale hydrogenation
- Diborane chemistry
- Ethylene oxide reactions
- Biocatalysis platform
- Polymer production (PLGA)
- Enzymatic synthesis Skraup reactions
Last inspections:
- FDA 2018
- ANSM 2021
EcoVadis CSR Rating: Silver certification
Bourgoin-Jallieu
France38300 Bourgoin-Jallieu
Flagship technologies: Distillation
Villeneuve la Garenne
France92390 Villeneuve-la-Garenne
Capabilities:
- 70 m³ of GMP reactors
- 100 L – 8 000 L vessels
Flagship technologies:
- Optical resolution
- Enzymatic hydrolysis
- Enantioselective reduction
- Low-temperature reactions (-80 °C)
- Specific reduction
- Hydrogenation (40 bar)
- Organomagnesium compounds
- Thin-layer distillation
Last inspections:
- ANSM 2019
- ANVISA (Brasil) 2018
- FDA 2016
Turku
Finland20210 Turku
Surface: 11 678 m²
Lab surface: 695 m²
Capabilities:
- 4 separate modules
- 72 m³ reactor capacity-
- 250 L – 6300 L vessels
Flagship technologies:
- Biphosphonate chemistry
- Hydrogenation (20 bar)
- Chlorination
- Cyanation (NaCN) in separate installations
- Reduction with complex hydrids
- Biocatalysis
- Manufacturing of parenteral/injectable APIs
- Separate production modules and final processing facilities
Last inspections:
- FDA 2019
- PMDA 2018
- FIMEA 2018
Number of scientists: 16
Newburyport
United StatesMA 01950 Newburyport
Custom Manufacturing: don.laferle@seqens.com
Proprietary API: laurent.alexandre@seqens.com
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
