Custom Development & Manufacturing
With 7 cGMP/ FDA inspected plants in Europe, Israel and the United States for commercial production supported by two pre-GMP (ISO 9001) sites in France, our customers have access to a powerful industrial network of facilities with a high level of quality, safety and environmental compliance.
Seqens invests on an ongoing basis in its production sites to provide the pharmaceutical industry with state-of-the-art equipment combined with cutting-edge technology in organic chemistry associated with proprietary gene shuffling technology for unique biocatalytic routes.
We conduct GMP manufacturing of APIs or intermediates from kilo to multi-ton quantities. Our range of scale and seamless collaboration within our manufacturing sites allow Seqens to accommodate most projects regardless of size and complexity.
Our services include
- Process and analytical validation
- Kilo-scale, pilot scale and commercial multi-ton cGMP manufacturing
- Production in two locations for supply chain security
- Quality control and quality assurance
- Back integration of early intermediates for supply chain security, cost or quality control
- Special technologies like cryogenic, hydrogenation, biocatalysis
HPAPI containment down to 100 ng/m3 OEL ( kilo scale to 200 kg batch size ) - Process optimization and second generation process for cost control
Regulatory support and filings Process and analytical validation - Kilo-scale, pilot scale and commercial multi-tons cGMP manufacturing
- Production in two locations for supply chain security
- Quality control and quality assurance
- Back integration of early intermediates for supply chain security, cost or quality control
- Special technologies like cryogenic, hydrogenation, biocatalysis
- HPAPI containement down to 100 ng/m3 OEL ( kilo scale to 200 kg batch size )
- Process optimisation and second generation process for cost control
- Regulatory support and filings
Production sites
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
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
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
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
Devens
United StatesMA 01434 Devens
Lab surface: 1 000 m²
Capabilities:
- Controlled substances (Schedule II-V)
- 5 Kilo-Labs
Number of scientists: 30
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
Protéus by Seqens
France30000 Nîmes
Surface: 1 000 m²
Lab surface: 500 m²
Capacities:
- 1 kilo-lab in fermentation (80 L total capacity)
- Robotic platform for highthroughput screening (HTS)
- Analytical platform for chromatography (GC, GC-MS, U-HPLC)
Flagship technologies:
- Protein engineering
- Microbiology aerobic & anaerobic
- Syngas fermentation
- Enzymes & strains fermentation
- Biochemistry
- Biocatalysis
- Design of experiments (DoE)
- Data mining
Number of scientists: 19
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