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.
| 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 |
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 |
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 | |
| HIC columns | |
| Reversed-phase columns |
YMC can offer custom purification services from laboratory scale to plant scale, including GMP-conforming purification.
Application list
