Bioseparation

Powerful tools supporting biopharmaceutical purification

Biopharmaceutical manufacturing processes have high costs. This is because a multi-step purification 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. YMC provides products and services for biopharmaceutical purification, including packing materials (bulk media) and chromatography devices that can realize reduced process costs.

Manufacturing processes of biopharmaceuticals

Capture Purpose Isorate and concentration of protein
Separation mode Affinity chromatography
Ion exchange chromatography
Hydrophobic interaction chromatography
Required performance High loading capacity
Easy to scale-up
Intermediate Purpose Removing the majority of protein impurity
Separation mode Ion exchange chromatography
Size exclusion chromatography
Hydrophobic interaction chromatography, etc.
Required performance High resolution
Easy to scale-up
Polishing Purpose Removing trace protein impurities
Separation mode Size exclusion chromatography
Ion exchange chromatography
Reversed-phase chromatography
Required performance High resolution

We offer downstream purification products.

YMC lineups include packing materials (bulk media), preparative columns (e.g., glass columns), and preparative chromatographic devices for biopharmaceutical purification. We can propose optimal combinations of packing materials and devices according to the intended application.

  Product name Suitable preparative devices
Ion exchange media
Size exclusion packing materials
Reversed-phase packing materials

Quality control of biopharmaceuticals

Biopharmaceuticals, such as monoclonal antibodies (mAbs), contain impurities derived from the host cell and related substances, as they are often produced from cell cultures and are easily denatured compared with low-molecular-weight pharmaceuticals. For quality control, high-resolution columns are required to separate many of related substances, including isoforms. YMC's various product lineups, such as ion exchange columns and reversed-phase columns, which have high performance and high lot-to-lot reproducibility, are suitable for quality control.

  Product name
Ion exchange columns
Aqueous size exclusion columns
Reversed-phase columns

Contract purification services

YMC can offer custom purification services from laboratory scale to plant scale, including GMP-conforming purification.

Technical data