Preparative chromatography has been widely used as a purification technique for pharmaceutical APIs. Purity, recovery (yield), throughput and cost are the drivers in this industry. Preparative chromatography provides customers with sufficient amounts of materials with the desired quality to initiate preclinical and clinical trials. This allows for alternative commercialization routes to be explored with no loss in development time.
The priority in purification depends on the development stage. In preclinical chemistry, the key is a quick method of development to have samples ready for initial activity tests. At this early stage, while time is a major factor, purification cost is not emphasized because the synthesis is carried out on a very small scale.
ZEOprep and ZEObeads
Flash chromatography is a widely used method to provide larger quantities of pre-purified material. This complimentary technique can also be used as a powerful tool for (non-chiral) pre-purification steps in the early development/preclinical phases of API manufacturing.
For the early API stage, Zeochem supplies efficient irregular shaped (ZEOprep) silica and microbead shaped (ZEObeads) silica in various pore and particle sizes, as well as modifications. When it comes to removing catalyst for API manufacturing steps, bonded irregular silica can be used as a reliable and cost-efficient scavenger.
During late clinical phases and in the commercialization phase when the active pharmaceutical ingredient (API) is required at large scale, the process needs to be carefully optimized to reduce the costs and maximize efficiency. Our ZEOsphere Classical silica provides all required reversed phases for the more complex preclinical, clinical and commercialization phases.
ZEOsphere DRP Mixed-Mode products can substantially reduce production costs of charged APIs. Higher recovery (yield) can be achieved from the improved selectivity, while also decreasing the organic solvent usage. Depending on the objective, a single-step purification is highly possible.