Learning path · Intermediate
Biologics QC essentials
How a therapeutic protein is tested: content, purity, size and charge variants, identity and process impurities.
- 10 steps
- For: Biotech students and new biologics QC analysts
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- ReadQC of biologics: what is tested and whyICH Q6B attributes in plain language.
- ReadProtein concentration by A280The quickest way to know how much protein you have.
- CalculateStandard curve calculatorUsed for BCA / Bradford and many plate assays.
- ReadPurity by SDS-PAGESeparating proteins by size on a gel.
- ReadAggregates by SEC-HPLCMonomer, high- and low-molecular-weight species.
- ReadCharge variants by cIEFAcidic, main and basic forms.
- ReadIdentity by peptide mappingConfirming the sequence by LC-MS.
- ReadHost cell protein by ELISAThe main process-related impurity.
- ReadResidual DNA by qPCRMeasuring trace DNA left from the cells.
- PractiseTest yourself on the qPCR systemMCQs and viva questions.