Characterization of Biologics

We provide services for protein analysis according to ICH Q6B guidance, including the analytics as shown below.

• Structural characterization and protein confirmation

• Physicochemical haracterization

• Higher order structure analysis

• Quantitation

• Analysis of biological activity/potency assays

• Purity analysis

• Quantitative and qualitative measurement of impurities

We provide services for the characterization of primary structure, higher order structure and confirmation according to EMEA, FDA and ICH guidelines. These services include:

Post translational modifications are very common for biologics, due to the various modifications introduced over the lifespan of biomolecules from the point of biosynthesis to the point of complete clearance from the patients. These modifications are both enzymatic and non-enzymatic, which create great challenge for thorough characterization of the biopharmaceuticals. Common enzymatic and non-enzymatic post translational modifications of biopharmaceuticals include: deamidation, oxidation, phosphorylation, glycation, etc. These modifications may affect the structure and functions of biologics.

We provide services for analysis and characterization of post translation modifications as described below:

Impurity testing along with their identification, quantification and analytical control strategies are important for the purity, safety, and quality of drug substances and drug products. Impurities often present at very low or trace levels in highly complex sample matrices, and consequently, highly sensitive and specific analytical methods are required to identify and quantify them. Based on the sources of the impurities, these impurities are divided into four categories:

• Process-related impurities

• Product-related impurities

• Inorganic impurities

• Solvents
  

Forced degradation or stressed studies help to identify the degradation pathways of biologics. Identification and characterization of potential degradation species will help to establish the critical quality attributes (CQAs).

Our services for protein degradation studies include:

• pH stress

• Photostability (per ICH Q1B)

• Mechanical stress studies

• Forced oxidation studies

• Shipment studies

• Aggregation studies

• Freeze-Thaw studies

Biosimilar product is a biological product that is highly similar and has no clinically meaningful differences from an existing FDA-approved innovator product. A manufacturer developing biosimilar products must show that the biosimilar product is highly similar to the innovator product by extensively characterizing the structure, function and bioactivity of the reference standard, innovator product and biosimilar product. Following analyses are performed to establish similarity between Innovator, reference standard and Biosimilar.

• Analysis of physicochemical properties

• Analysis of structural attributes

• Potency assays

• Primary structural analysis

• N- and C-terminal sequencing

• Intact mass analysis

• Reduced mass analysis

• Higher order structural analysis

• Disulfide linkage analysis

• Studies on other post-translational modifications

Comparability studies are important to ensure that process or manufacturing changes will not adversely affect the quality, safety, efficacy, etc. of the biological product. We provide services for comparability studies according to ICH Q5E guidance which include analysis of physicochemical properties, biophysical properties and potency. Our services on comparability studies include: