Biopharmaceutical products are synthesized by living cells, and hence during the purification process the substrates for growth, host cell components and product variants must be removed. These impurities include:
Product characterization methods in the biopharmaceutical sector have seen considerable advances in recent years, particularly with the development of high-resolution-MS approaches, for example in our ability to investigate glycosylation of antibodies. The need for advanced characterization is also being driven by the biosimilars market where a company developing a generic product must show to the regulators comparability to the innovator product.
Profacgen offers a wide range of pharmaceutical services which includes biopharmaceutical product related impurities analysis. A variety of compounds added during the manufacture process of your biopharmaceutical products can appear in the final product as process- and product- related impurities. We provide you with effective process related impurities analysis, and product related impurity testing in biopharmaceuticals. As a result, we can help you to confirm the efficient removal of impurities by the downstream process and absence from the final product.
We offer the following technologies for process-related impurities analysis, residual impurity testing and residual analysis in biopharmaceuticals:
|Product Related Impurity||Method Description|
|Host cell proteins (HCP)||Commercial kit or customized assay|
|N-terminal truncations||N-terminal sequencing|
|Host cell DNA||PCR|
|Oxidation/deamidation (PTMs)||Peptide mapping LC-MS or LC-MS/MS, IsoQuant HPLC|
|Isoform analysis||Ion exchange HPLC, cIEF, sialic acid analysis|
|Disulfide bridge scrambling (mis-folding); conformational impurities||Peptide mapping LC-MS or LC-MS/MS, Ellman’s free sulfhydryl, intrinsic tryptophan fiuorescence, ANS dye binding, NMR|
|C-terminal integrity||Peptide mapping LC-MS or LC-MS/MS|
|Aggregation||Analytical ultracentrifugation (AUC), SEC/SEC-MALLS, dynamic light scattering (DLS)|
|Process Related Impurities||Method Description|
|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|
|PEG||HPLC with ELSD/CAD|
|Growth Factors (e.g., insulin, interferon)||ELISA|
With the vast base of isolation techniques and characterization technologies in our GLP / GMP compliant protein analysis laboratories, underpinned by over 20 years of experience in supporting biologic drug development and bioprocessing, we offer a full spectrum of ready-to-use analytical methods for the detection and quantification of process- and product-related residuals and impurities. Profacgen can ensure that you meet all regulatory expectations and specifications for your drug substance and drug product.
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