Lipid production: from synthesis to purification
High quality lipids are of great interest in the pharmaceutical industry, for example, as essential components of Lipid Nano Particles for RNA-based therapies. The production of such lipids requires multi-step synthesis and complex purification to be performed under a cGMP environment whilst preserving these fragile molecules from degradation of any kind.
As a leading CDMO in the manufacturing of complex APIs, Axplora is an expert in combining synthesis and DownStream Processing (DSP) using modern chromatographic purification.
Expertise in lipids production
Axplora, through its Novasep heritage, has a proven track-record in lipid process development and manufacturing, providing reliable and agile solutions to innovators.
Our expertise in performing complex / delicate downstream processing for pharmaceutical ingredients for chemical or bioprocesses is recognized by our innovator customers, from large pharmaceutical to biotechnology companies.
- A long-standing expertise
- > 20 years of experience with lipids
- > 300 clinical and commercial cGMP lipid batches produced
- Outstanding regulatory & quality assurance track record
- All Axplora’s sites regularly inspected by the US-FDA and European authorities
- >98% compliant batches
- A reliable partner
- Pioneer and market leader in preparative chromatography for pharmaceutical manufacturing through our Novasep heritage
- Strong commitment to sustainable and cost-effective processes
- Agile and responsive teams
- The largest range of installed industrial purification/chromatographic equipment in the world, offering manufacturing solutions from grams to multi-tons
- 3 sites with capabilities to perform complex chemistry coupled with state-of-the-art chromatography equipment
Our solutions for lipid production
Axplora offers a full range of services for lipids, from synthesis to purification, covering process and analytical development to clinical and commercial manufacturing.
- Process development to scale-up
- Feasibility studies & process development
- Analytical transfers
- Process transfers & optimizations
- Design of Experiment
- Proof of Concept (PoC) batches
- cGMP & non GMP manufacturing
- Process validation
- Analytical validation
- Cleaning validation
- Regulatory support
- Commercial manufacturing
- Support to clinical supply
- Routine commercial production from kgs to multi-tons scale
- Continuous improvement
Our sites offering capabilities to produce lipids
Three of our sites can produce lipids.
- Our Chasse-sur-Rhône site in France has the ability to perform complex chemical development and GMP manufacturing from kgs to multi-tons scale, coupled with a wide range of chromatography capabilities.
- Our Axplora Mourenx site, located in south-west France, is home to the largest cGMP purification plant, but also large cGMP chemical manufacturing capacities.
- Our Pompey site, located in France, is Axplora’s center of excellence for chromatographic purification.
Discover our CDMO services and technologies for APIs: