Small molecule purification: a key technology for small molecule API purification
The production of an API and key intermediates requires a robust and effective process to deliver 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.
Through its Novasep heritage, Axplora is a pioneer and market leader in preparative chromatography for pharmaceutical manufacturing. This is demonstrated by its recognized expertise in small molecule purification.
- Our expertise in small molecule purification
- Our track record & wide range of purification technologies
- Our first-class solutions for your small molecule purification needs
- Our FDA-inspected manufacturing sites for small molecule purification and chemical synthesis
- Our capabilities for your chromatography projects
Our preparative chromatography expertise
Axplora is acknowledged as a world leader in preparative chromatography with:
- A 30+ year track record in chromatography equipment design and commercial manufacturing
- Over 20 API manufacturing processes validated using chromatography
- 1000’s tons API produced with industrial chromatography (>3000 batches)
- An industry-leading range of chromatography equipment, designed by Novasep and installed across 5 of our sites to answer every need from laboratory to production scale
As a leading provider of industrial chromatography services, Axplora benefits from extensive in-house expertise and offers a full range of services for purification & chiral separation of APIs, HPAPIs, cGMP intermediates and fine chemicals.
Our strength lies in our ability to combine organic chemistry with advanced purification steps under both batch & continuous (SMB) modes, as well as Low- and High-pressure Chromatography, tangential flow filtration, etc.
Based on our strong expertise, we can help you tackle your purification challenges and recommend the right chromatography technology for your project.
A solid track record backed by a wide range of purification technologies
Our track record includes development and manufacturing using chromatography for synthetic molecules such as
- Chiral separations
- Oligonucleotides
- Peptides
- ADC payloads
- Purification of small molecule APIs from complex synthetic mixtures
- Purification of natural extracts and biomolecules.
To deliver a complete chromatography process, we go beyond chromatography and leverage a full range of additional advanced purification technologies, including:
- Concentration of small molecules and solvent recovery by distillation and falling film evaporators or thin film evaporators.
- Concentration and biomolecule recovery by membrane process using tangential flow filtration (UF, UF/DF)
- Isolation: crystallization and drying
- Solvent recovery up to 99.97% using patented and proprietary processes
Our first-class solutions for your small molecule purification needs
Axplora offers a wide range of cGMP manufacturing services using chromatography and other purification technologies, from process development to clinical and commercial supply.
We offer batch and 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
- Screening of stationary phases and eluents available from gram to ton scales
- Process Development study
- Process characterization/optimization (thermodynamic and kinetic parameters)
- Robustness study
- Stationary phase lifetime characterization and optimization
- Modeling and simulation of the chromatography step(s) where applicable
- Production costs estimate: with only a few grams of crude material, Axplora can determine future chromatographic purification costs at kg, 100’s kg or multi-ton scales with a high degree of assurance
- Proof of Concept (POC) study
- The first important scale-up to confirm the lab-scale process and/or simulation results
- Implementation & fine-tuning of the process
- Robustness study (impact of loading, eluent composition, flow rates, cycle times…)
- Recyclability of the solvents
- Product isolation study
- 10s gram to Kg scale sample production
- Scale-up and technical batch
- Preparation & documentation
- Production
- Analysis
- Manufacturing of cGMP batches
- Clinical or commercial production
- Analytical methods transfer, qualification and validation if necessary
- Validation
- Process characterization
- Production of PPQ batches and process validation
- Analytical method(s) validation
Our teams are experts in integrating chromatographic step(s) in the global manufacturing process: you can rely on Axplora to develop and implement full downstream processing before and after chromatography steps.
Five sites offering preparative chromatography
Five of our sites are equipped & experienced to propose chromatography services:
| Sites | Screening, process development and POC study | Scale-up and clinical manufacturing | Validation and commercial manufacturing | |||
| Wilmington, DE (USA) | X | |||||
| Chasse-sur-Rhône (FR) | X | X | X | |||
| Mourenx (FR) | X | X | ||||
| Pompey (FR) | X | X | X | |||
| Le Mans (FR), (ADC 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 Axplora’s chromatography capabilities, download our industrial chromatography leaflet:
