Biopharmaceutical products synthesized by living cells require rigorous purification to remove growth substrates, host cell components, and product variants. Comprehensive impurity profiling is essential for regulatory compliance and is particularly critical in the biosimilars market, where demonstrating comparability to innovator products is mandatory. Our GLP/GMP compliant laboratories offer advanced characterization technologies, including high-resolution mass spectrometry, to ensure your drug substance and product meet all regulatory specifications.
Product-related impurities are variants that differ from the desired product structure. We provide specialized testing to identify and quantify these critical quality attributes:
| Impurity Type | Analytical Method |
| Host cell proteins (HCP) | Commercial kit or customized assay |
| Host cell DNA | PCR |
| N-terminal truncations | N-terminal sequencing |
| C-terminal integrity | Peptide mapping LC-MS or LC-MS/MS |
| Oxidation/deamidation (PTMs) | Peptide mapping LC-MS or LC-MS/MS, HPLC |
| Disulfide bridge scrambling & conformational impurities | Peptide mapping LC-MS or LC-MS/MS, Ellman's free sulfhydryl, intrinsic tryptophan fluorescence, ANS dye binding, NMR |
| Isoform analysis | Ion exchange HPLC, cIEF, sialic acid analysis |
| Aggregation | Analytical ultracentrifugation (AUC), SEC/SEC-MALLS, dynamic light scattering (DLS) |
Process-related impurities encompass materials added during manufacturing and residual cellular components that must be demonstrated absent from final product:
| Impurity Type | Analytical Method |
| Protein A | ELISA |
| PEG | HPLC with ELSD/CAD |
| Growth Factors (e.g., insulin, interferon) | ELISA |
| IPTG | HPLC with ELSD/CAD |
| PEI | HPLC with ELSD/Fluorescence |
| Kanamycin | HPLC with UV/Vis |
| Anti-foam | HPLC with ELSD/CAD |
| TFA/Acetate | HPLC with UV/Vis |
| Cyanate | HPLC with Conductivity/ECD |
| Imidazole | HPLC with Fluorescence |
| Triton X-100 | HPLC with ELSD/CAD |
| Polysorbate (Tween) 20/80 | HPLC with ELSD/CAD |
| Zwittergent | HPLC with ELSD/CAD |
| Pluronic | HPLC with ELSD/CAD |
| TRIS | HPLC |
With over 20 years of experience supporting biologic drug development, we deliver a full spectrum of ready-to-use analytical methods for detection and quantification of all process- and product-related residuals. Our expertise ensures efficient downstream process validation and confirms impurity absence in your final product, meeting global regulatory expectations.
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