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-related impurities: variants that differ from the desired product;
- • Process-related impurities: materials added to the process and cellular components.
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 |
| Protein A |
ELISA |
| PEG |
HPLC with ELSD/CAD |
| TRIS |
HPLC |
| 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.
