cGMP Medical Polymer Synthesis
Seqens’ technical and manufacturing teams have successfully completed countless cGMP medical-grade polymer synthesis projects, including:
- Drug delivery technology
- Excipients
- Medical devices (510k)
- Medical-grade coatings
- Therapeutics
These projects begin in our laboratories, to enable our teams to improve many polymerization processes and to adopt the latest analytical techniques supporting their development. Seqens has the capacity to produce our cGMP polymers in quantities ranging from kilos to tons.
Key Services
Polymers for pharmaceutical applications
Recent Polymer-Related Projects
PEKK polymers
- PEKK (Poly-Ether-Ketone-Ketone) polymers, which are useful for long-term implantable human devices with a life cycle of several years. These polymers are widely used as orthopedics, neurological, dental, spinal and cardiovascular implants as well as in PEKK-based 3D-printed bones.
Seqens alsooffers development of other cGMP medical grade polymers such as hydroxybutyrate, (poly)ester, acrylate and methacrylate copolymers.
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
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
Newburyport
United StatesMA 01950 Newburyport
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
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
Devens
United StatesMA 01434 Devens
Lab surface: 1 000 m²
Capabilities:
- Controlled substances (Schedule II-V)
- 5 Kilo-Labs
Number of scientists: 30
