With our unique expertise and more than 30 years’ experience in the development and cGMP manufacturing of chiral intermediates and APIs, we can propose a wide toolbox of stereoselective transformations and chiral purifications to meet the specific requirements of your molecule.
Asymmetric synthesis and biocatalysis
Chiral molecules have received in the past years an increased attention from the pharmaceutical industry in search for new and more selective drug candidates.This trend is being confirmed by the proportion of chiral APIs that have been approved by regulatory authorities.
Novasep has extensive experience in manufacturing chiral intermediates and APIs applying different strategies depending on synthesis requirements:
- Transformation of intermediates from chiral pool or from sourced advanced chemical intermediates up to final chiral API manufacturing
- Asymmetric transformations from chemical of biochemical means
- Purification of racemic mixture (crystallization / chromatography)
Our expertise and capacities in cryogenic reactions, organometallic catalysis and hydrogenation are clearly very strong assets to successfully conducting stereoselective reactions. Our teams of experts can deliver robust manufacturing solutions for complex chiral molecules.
Biocatalysis is a very efficient method to introduce chirality by means of chiral transformation or resolution of racemic intermediates. These reactions are often very efficient and selective. These transformations have a key advantage of not relying on the use of transition metals and are generally performed under aqueous media making this approach more sustainable. Coupling our capabilities to perform biocatalytic reactions with capabilities for tangential filtration (UF/NF) at manufacturing scale ensures a smooth process integration from the reaction to the downstream processes of these complex steps.
The purification of racemic mixtures by means of crystallization (diastereomeric salt formation) or chromatography is also an important strategy used in API manufacturing. Novasep as a leader in enantiomeric purifications can provide solutions to resolve difficult separations for our customers.
We combine our experience in designing and operating industrial chiral chromatography processes with our expertise in scaling up challenging organic synthesis, to offer our customers a holistic and cost-effective solution for the manufacture of chiral APIs.
To support clinical development, validation and launch, we offer an extensive range of high-performance liquid chromatography systems (HPLC), one of the most versatile chromatographic tools to perform chiral resolution with a wide range of racemic mixtures, even if they are highly polar or cytotoxic.
For late development and production, we propose the use of continuous chromatography system which is the most cost-effective, robust and environmentally friendly route to produce your pure enantiomer at large-scale. Efficient and integrated solvent recycling translates into lower operational costs and minimizes solvent consumption.
Want to learn more about preparative chromatography for APIs and intermediates and understand when to use batch and continuous chromatography technologies? Watch the video below:
