Biopharmaceuticals (Biological Source)

Biopharmaceutical manufacturing processes have high costs due to the multistep purification process, which is required to separate the many components generated during the cell culture step. The manufacturing process is roughly divided into upstream processes, including cell culture, and downstream processes, including purification. Purification using chromatography in the downstream process includes three steps: initial purification (capture), intermediate purification and final purification (polishing). In each step, the packing material (bulk medium) and chromatography device are chosen depending on the intended purpose.

Based on the interaction between the solid stationary phase and biomolecules, chromatographic techniques can be summarized into five classes: (i) affinity, (ii) ion-exchange, (iii) hydrophobic interactions, (iv) size exclusion and (v) mixed-mode chromatography.

Zeochem’s irregular shaped ZEOprep silica is a column packing material approved over decades for allowing highly reproducible results. Used primarily in upstream and downstream stages of biopharmaceutical processes, ZEOprep and ZEObead products offer high performance, high permeability and excellent selectivity, in addition to effective and reproducible separation.

Zeochem’s ZEOsphere DRP Mixed-Mode silica is an excellent choice for the purification of charged intermediates and as a polishing step. ZEOsphere DRP Mixed-Mode can substantially increase recovery/yield while decreasing organic solvent usage due to improved selectivity capabilities.

Applications

APIs Purification

ZEOsphere silica can be used for developing a robust production process to purify APIs.

With over 25 years of expertise in the development of preparative Liquid Chromatography purification processes, ZEOsphere silica has proven to be a reliable partner in the delivery of high-quality, reproducible silica-based stationary phases for HPLC-based purification processes.

Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) is widely used in the biopharmaceutical industry. Analytical RP-HPLC is used for the release and characterization of raw materials, intermediates and APIs. Preparative HPLC is used for the commercial production of APIs that are not amenable to crystallization. The currently used stationary phases are not always suited for this task due to required cost reductions and the increasing complexity of APIs.

ZEOsphere DRP Mixed-Mode silica is an excellent answer for the purification of charged intermediates and as a polishing step for APIs. ZEOsphere DRP Mixed-Mode materials can substantially increase recovery/yield while decreasing purification costs through improved selectivity capabilities.

  • Amino acids
  • Biosimilars
  • Peptides
  • Proteins
  • Oligonucleotides
  • Vaccines

Related Products

ZEOsphere silica is an excellent choice for the purification of (charged) intermediates and as a polishing step. ZEOsphere DRP Mixed-Mode can substantially increase recovery/yield while decreasing purification costs through improved selectivity capabilities.

Spherical Shape

ZEOsphere classical silica-based stationary phases offer excellent separation performance for any type of separation or purification applications.

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Custom Solutions

Preparative column chromatography (advanced normal phase and reversed phase chromatography) plays an important role in purifying valuable compounds used in research, pilot plant operations and production. Zeochem's ZEOsphere product line delivers high purity and high yield in an efficient manner.

ZEOsphere stationary phases will deliver reproducible results within narrow band ranges. This provides the highest degree of reliability for chromatographic separations and purifications.