With a recognized 10 years-experience in Custom Lipids development and manufacturing, Seqens has the ability to serve customers with cationic/ionizable lipids, PEG-lipids, phospholipids and derivatives.
Lipids usage :
- Cationic/Ionizable lipids for RNA encapsulation and vacines
- API encapsulation through liposome vectorization
The manufacturing process of lipids requires multi-steps synthesis and several product isolation and/or chromatography purification steps.
Scalability for both the synthesis and purification operations is considered from the very beginning to ensure an economy of scale with increasing batch size, with the aim of minimizing the number of synthetic steps and simplifying the purification steps whenever possible.
Track record & Successes
An integrated cGMP Lipids platform targeting increased performance and competitiveness
- 25+ years toll manufacturing agreements for large scale of Lipids used in commercial pharma and cosmetic applications
- 10 years of successful track record on custom lipids development and manufacturing
- 100 inspections passed since 1987 on our cGMP sites by authorities worldwide (US FDA, ANSM, Anvisa, PMDA, KFDA, TMMDA, Health Canada, ThaiFDA etc.)
- Back integration and double-sourcing capabilities, US and EU
On-going investments, notably in France to contribute in securing a local supply chain, aim to further strengthen our integrated cGMP Lipids platform with new state of the art equipment and technologies, including specific lab analytical tools and additional chromatography-purification systems, targeting reduced environmental footprint, high quality & safety standard, increased performance and competitiveness.
CMC project management
Our expertise in the CMC and regulatory environment is essential for the successful development and commercialization of lipid-based drug products.