Physicochemical Properties of proteins or biologics

Determination of physicochemical properties of proteins, antibodies or other biological products in line with ICH Q6B, EMA and FDA guidelines

Determination of physicochemical properties for a biologics such as proteins by appropriate techniques is necessary to allow relevant specifications to be established and support biologic development and ongoing quality control of products.

A range of methods and technology are required to determine the physicochemical properties of your specific desired product. The challenge is to select and adapt the most appropriate technical approaches to the product in question.

Our scientists deliver protein physicochemical property analytical programs in line with appendix 6.1.2 in the ICH Q6B guidelines Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Our programs are designed to optimise the data required to determine or confirm identity, explore patterns of heterogeneity and demonstrate consistency in quality of the drug substance. 

We are adept at method development and phase-appropriate validation where required.

Our expertise in developing, validating and conducting physicochemical testing combined with range of techniques makes Intertek the perfect partner to expedite your protein structural characterisation programs to meet your development, submission or ongoing processing needs.

 
Our scientists apply a range of techniques to determine molecular weight such as size exclusion chromatography (SEC), SDS-polyacrylamide gel electrophoresis (under reducing and/or non-reducing conditions) and mass spectrometry. We offer the determination of exact molecular weight of proteins or other biologics in a drug sample using LC ESI-MS with comparison against the expected molecular weight of the drug substance.
The Isoform Pattern of therapeutic proteins is critical for characterising quality attributes. Intertek uses tools such as imaged capillary isolectric focusing (iCIEF) and Ion Exchange Chromatography (IEX) for this analysis.
Our protein scientists accurately determine the extinction coefficient using UV/visible absorbance on solutions of the product which have a known protein content. We quantify the concentration of protein in solution using amino acid compositional analysis, either by using an amino acid analyser or UPLC instrumental approaches.
Electrophoretic patterns and data on identity, homogeneity and purity can be obtained by polyacrylamide gel electrophoresis, capillary isoelectric focusing (CIEF), SDS-polyacrylamide gel electrophoresis, Western-blot or capillary electrophoresis.
Using size exclusion chromatography (SEC), reverse-phase liquid chromatography (RP-HPLC), ion exchange liquid chromatography (IEX), or UPLC approaches we generate chromatographic patterns and data on the identity, homogeneity, and purity.
The ultraviolet and visible absorption spectra are determined as appropriate. The higher-order structure of the product is examined using circular dichroism (CD), nuclear magnetic resonance (NMR), infrared (FTIR) or fluorescence spectroscopy.
We provide a range of total protein quantification methods, including European Pharmacopoeia (EP) and United States Pharmacopeia (USP) methods. Colorimetric assays such as the Bradford or bicinchoninic acid (BCA) assays measure UV-light absorbance and can be used to calculate protein concentration from the absorbance measurement, once the extinction coefficient (molar absorptivity) has been accurately established. We also provide quantitative amino acid analysis by high performance liquid chromatography (HPLC) or ion chromatography (IC).
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
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