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Biotechnology Services
Process Validation for Viral Clearance |
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Types of Process Regularly Evaluated
- Pasteurization
- Dry heat
- pH inactivation (e.g. pH 4.0)
- Solvent/detergent inactivation (e.g. tri-n-butyl phosphate [TNBP]/Triton X-100)
- Chemical inactivation (e.g. caprylic acid)
- Ethanol precipitation (e.g. 40% ethanol precipitation)
- Nano-filtration (e.g. dead end filtration and tangential flow filtration)
- Affinity chromatography (e.g. Protein A)
- Gel filtration chromatography
- Ion exchange chromatography
- Gamma-irradiation
- Precipitation (e.g. ethylene glycol)
- Lyophilization.
Although many of these processes are well-established techniques, the study design is tailored to meet individual requirements. |
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