The production of an API or key intermediate requires a robust and effective process, delivering a high purity pharmaceutical product. Depending on the nature of the process and the characteristics of the product, several techniques may be considered.
Preparative chromatography is often the method of choice for separating, purifying and isolating substances from complex mixtures.
Our preparative chromatography expertise
Novasep is a world leader in preparative chromatography, with:
- A 30+ year track record in commercial manufacturing
- Over 30 successful chromatography process development & manufacturing projects each year, in both batch and continuous mode
We offer a full range of CDMO services with industrial chromatography for purification & chiral separation of APIs, HPAPIs & cGMP intermediates using both batch and continuous HPLC (High Pressure Liquid Chromatography). Discover our FAQ to learn more about HPLC!
As a leading supplier of industrial chromatography equipment (Hipersep®, Varicol®…), Novasep benefits from in-house expertise. A wide range of high-performance automated equipment is installed & dedicated to CDMO activity across 5 of our sites.
To learn more about our preparative chromatography expertise, check out our case study & watch our webinar recording:
Type of content
Watch the video below to find out when to use batch and continuous chromatography technologies and choose the right one for your API project:
A solid track-record in chromatography
Our track record includes development and manufacturing using chromatography for:
- Synthetic chemistry: Small molecules, Chiral molecules, Oligonucleotides, Peptides, ADC payloads…
- Natural extracts: Alkaloids, Flavones, Glycosides, Saponins, CBD…
- Animal extracts: Omega 3, Lipids, Milk protein, Proteins from serum…
- Fermentation: Peptides, Proteins, Insulin, Rapalogs, Taxanes, Antibiotics (except beta-lactams) …
- Cell Culture: Recombinant proteins, Monoclonal Antibodies …
Our preparative chromatography solutions
Novasep offers a wide range of cGMP CDMO manufacturing services using chromatography, from process development & clinical supply to commercial manufacturing. We offer both batch & continuous chromatography at scales from 10’s of grams to 100’s tons per year.
From feasibility studies to process validation and qualification, we offer customized solutions to design, develop and optimize your chromatography process:
- R&D services: solubility test, screening of available stationary phases…
- Transfer of analytical methods
Process Development study
- Loading study
- Robustness study
- Modeling and simulation of the chromatography step(s)
Proof of Concept (POC) study
- First important scale-up to confirm the lab-scale process and/or simulation results
- Implementation & fine-tuning of the process
- Robustness study (injection amount, collection time, flow rates, cycle times…)
- Isolation study
- 10s gram to Kg scale production if necessary
- Preparation & documentation
Manufacturing of cGMP batches
- Clinical or commercial production
- Analytical methods qualification if necessary
- Process characterization
- Process validation
- Analytical method(s) validation
5 sites offering preparative chromatography
5 of our sites are equipped & experienced to propose chromatography services:
Screening, process development and POC study
Scale-up and clinical manufacturing
Validation and commercial manufacturing
Le Mans (France), dedicated to HPAPIs manufacturing
Located in the US and France, our facilities have been successfully inspected by the FDA, the PMDA and the European authorities recently.
Our capabilities for your chromatography projects
To learn more about Novasep’s chromatography capabilities, download our industrial chromatography leaflet!
Do you want to learn more about High Performance Liquid Chromatography? Check out our FAQ!