AAnalytical method development and validation

BAssay services

1.Physical properties

1.1Appearance

1.2Color

1.3Clarity

1.4PH

1.5Osmolality

1.6Visible particulates

1.7Particulate matter

2.Ldentity test

2.1Isoelectric focusing, IEF

2.2Peptide mapping HPLC

2.3CEX-HPLC

2.4Glycan profile

3.Purity

3.1SDS-PAGE

3.2Capillary electrophoresis, CE

3.3SEC-HPLC

4.Impurities

4.1Residual protein A

4.2Residual host cell protein

4.3Residual host cell "DNA"

5.Potency test

5.1Bio-assay

5.2Binding assay

6.Safety

6.1Sterility

6.2Endotoxin

6.3Mycoplasma

7.Quantity

7.1AAA test – for extinction coefficient

7.2Antibody concentration in harvest, ProA-HPLC

7.3Protein content

CRaw material specifications and tests

DProtein structural characterization

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We can develop specific bio-assays for your project, including assay cell lines.