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.
Which molecules can be purified by preparative chromatography?
- Synthetic molecules (APIs, HPAPIs, ADC payloads, Oligonucleotides, Peptides…)
- Natural extracts (Leaves, Roots, Fruits, Flowers, Seeds, Algae…)
- Animal extracts (Omega 3, Lipids, Milk proteins, Plasma, Oils…)
- Fermentation broth (Insulin, Rapalogs, Taxanes…)
- Cell culture (Recombinant proteins, mAbs…)
How does chromatography work?
Chromatography is a process for separating substances in a mixture, by using their different interactions with a stationary phase, for a specific eluent.
What are the benefits of preparative chromatography?
- Key tool to achieve high purity level
- Flexibility in process development
- Easy & linear scale-up
- Established technology at commercial cGMP scale
What are the differences between batch and continuous chromatography?
Choice depends on:
- Nature of the compounds
- Nature of the separation
- Scale of the operation
Looking for more information about Preparative Chromatography for APIs and the use of Batch & Continuous technologies?
Watch our video!