Pharmaceuticals (Synthetic)

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.

ZEOsphere

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.

Applications

Medicinal Chemistry

In today's competitive environment, synthetic chemists are required to deliver a large number of compounds for screening, while also focusing on cost reduction and speed to market. The purification process can often be a source of bottlenecks which has created a need for optimizing the process to meet the product quality requirements.

To optimize the process, normal-phase, reversed-phase and ion-exchange chromatography are frequently used as separation or purification techniques. Our ZEOsphere product line offers all required silica-based stationary phases by removing bottlenecks and guaranteeing the highest technical and economic efficiency for the purification processes.

Due to improved selectivity, our ZEOsphere DRP Mixed-Mode product line can decrease purification time and substantially increase yields. Working with ZEOsphere DRP products will also decrease your organic solvent consumption.

Active Pharmaceutical Ingredients (API)

For the purification of small molecules, peptides (NCE or generics), insulin (analogues), proteins and oligonucleotides, it is often difficult to use methods similar to those applied in the purification of other compounds, mainly due to their complexity. Purification methods usually utilize various principles of chromatography, such as ion exchange chromatography and medium- or high-pressure reversed-phase chromatography.

Due to the increasing government and public pressure to decrease costs of medicines, the purification process should be as simple as possible and contain a minimum of steps. However, the reality is that by using today’s classical ion-exchange and or reversed-phase purification methods, multiple steps are still required to achieve the desired purity. Of course, this has a huge impact on recovery (yield). Also, a more organic solvent must be used — all resulting in an inefficient, costly purification process.

ZEOsphere DRP Mixed-Mode can substantially improve the selectivity of charged molecules from the adsorption on the hydrophobic sites and repulsion on the charged sites.

This enhanced selectivity leads to the desired purity more quickly and will considerably increase the recovery (yield). Because ZEOsphere DRP Mixed-Mode can work with low organic solvent conditions, a decrease in organic solvent usage is obtained.

ZEOsphere DRP Mixed-Mode is today’s answer to improving compound purification and considerably lowering production costs.

APIs Purification
  • Generics
  • Insulin (analogues)
  • Peptides
  • Proteins
  • Oligonucleotides
  • Small Molecules

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Irregular Shape

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Microbeads

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Custom Solutions

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