Drug Substance – Purification
Early Stage Purification
It is a process to extract viruses from the culture fluid from which cell and cell debris have been removed.
The culture fluid is removed through the use of ultrafiltration, impurities are purified through several steps of chromatography, and then the viral inactivation process is operated.
Late Stage Purification
It is a process to separate the inactivated viruses and replace them with a formulation buffer suitable for the final concentration and the final injection.
Through the final filtration, final impurities and viruses are removed, and bulk drug substance is produced.
Characteristics of Purification Process
- Prevent cross-contamination by separating the areas: before- and after- viral inactivation.
- Operated with 1,000L media/buffer preparation facilities and cGMP cleaning/sterilization facilities.
- To separate/purify various types of viruses, we have 50 mm to 450 mm of chromatography columns and the FPLC
that operates them.
- Have ultrafiltration/diafiltration equipment that can operate with a membrane area of 0.15 ㎡ to 10 ㎡ to
concentrate viruses and formulate bulk drug substances.
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