High-Potency APIs (HPAPIs)
Seqens has been involved in the small-scale production of potent compounds for many years. As an element of our growth strategy, the Company was seeking an opportunity to construct a potent unit at one of our network sites in Europe or the USA — in 2020, this plan officially came to fruition.
NEW POTENT DRUG API Synthesis MANUFACTURING UNIT
The facility consists of two units, located in the same building, a smaller one named UPP10 and a larger one named UPP30, to handle production of potent molecules from tens of kilograms to several hundreds. The initial capacity will be 10–15 tons per year.
The potent unit will maintain a maximum level of particles in the working environment of 100 ng/m3. This level will allow for the production of Safebridge category 3 potent compounds — molecules with occupational exposure limits ranging from approximately 30 ng/m3 to 10 μg/m3.
The modular unit is specifically designed to be flexible and allow for future investments as customers needs evolve.
This investment of 30 million euros in one of the 3 leading technologies in pharmaceutical synthesis demonstrates the SEQENS group’s ability to design, develop and industrialize the most complex molecules while maintaining a high level of performance in terms of quality, safety and respect for the environment.
SEQENS inaugurates its HPAPI unit, in the presence of Emmanuel Macron, President of the French Republic
Discover Villeneuve-La-Garenne site and its new Potent unit
Surface: 40, 000 m²
Lab surface: 2, 000 m²
- 6 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)
- 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 expertise
Last inspection: ANSM October 2018
Number of scientists: 110
Other: Ecosystem Pharma with integrated services
- 65 m³ of reactors
- 100 L – 2 500 L vessels
EcoVadis CSR Rating: Gold Certification
- ANSM 2019
- ANVISA (Brasil) 2018
- FDA 2016