Biopharmaceutical Process and Product Related Impurities Analysis

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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
Disul de bridge scrambling (mis-folding); conformational impurities	Peptide mapping LC-MS or LC-MS/MS, Ellman’s free sulfhydryl, intrinsic tryptophan uorescence, 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.

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