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Preparative chromatography: a key technology for the manufacture of APIs and intermediates
Pharmaceuticals

Preparative chromatography: a key technology for the manufacture of APIs and intermediates

Novasep Preparative Chromatography Banner

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.

Discover Everything you need to know about Preparative Chromatography:
Infographic Everything You Need To Know About Preparative Chromatography Thumbnail


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

Title

Case study 
Development and manufacturing of an Orphan Drug API using industrial chromatography: 
Success story from bench scale to commercial scale
Webinar recording
How to develop large scale chromatographic purification processes for APIs

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:

Screening

  • 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

Scale-up and Technical batch  How To Develop Large Scale Chromatographic Purification Processes For APIs Novasep

  • Preparation & documentation
  • Production
  • Analysis

Manufacturing of cGMP batches

  • Clinical or commercial production
  • Analytical methods qualification if necessary

Validation

  • Process characterization
  • Process validation
  • Analytical method(s) validation

Discover our infographic to learn more about our chromatography services:
Infographic How Novasep Can Suppport Your Chromatographic Projects


5 sites offering preparative chromatography

5 of our sites are equipped & experienced to propose chromatography services:

SITE

Screening, process development and POC study

Scale-up and clinical manufacturing

Validation and commercial manufacturing

Boothwyn (USA)

X    

Chasse-sur-Rhône (France)

X X X

Mourenx (France)

  X X

Pompey (France)

X X X

Le Mans (France), dedicated to HPAPIs manufacturing

X X X

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!

Preparative Chromatography Capabilities Novasep

Do you want to learn more about High Performance Liquid Chromatography? Check out our FAQ!

FAQs HPLC Thumbnail Novasep

Downloads
  • A full range of CDMO services for ADCs
    A full range of CDMO services for ADCs
    Find out the solution adapted to your needs with Novasep's fully integrated CDMO services for ADCs
    Download +
  • A full range of industrial chromatography services for APIs
    A full range of industrial chromatography services for APIs
    Discover more about Novasep's experience in industrial chromatography for the manufacture of APIs, H...
    Download +
  • Frequently Asked Questions: High Performance Liquid Chromatography
    Frequently Asked Questions: High Performance Liquid Chromatography
    Learn more about High Performance Liquid Chromatography (HPLC) in our FAQ!
    Download +
  • A full range of CDMO services for APIs
    A full range of CDMO services for APIs
    Novasep provides flexible development and manufacturing solutions for small molecules APIs and advan...
    Download +
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