Drug Development

The guidance document ICH Q5E provides a uniform set of internationally accepted principles for assessing the comparability of biotechnological and biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

The purpose of assessing comparability is to determine that the pre- and post-change drug product is comparable in terms of quality, safety and efficacy. In order to meet this goal the product should be evaluated at the process step most appropriate to detect a change in the quality attributes.

The tests for a comparability study should be selected and optimized to maximize the potential for detecting relevant differences in the quality attributes of the product resulting from the proposed manufacturing process change.

Biosimilar Development

In addition, the EMEA/CHMP/BWP/49348/2005 - Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues establishes quality requirements for a biological medicinal product claiming to be similar to another one already marketed.

These quality requirements are important to the development of biosimilars and are required to generate evidence demonstrating the similar nature with regard to the quality, safety and efficacy of the biosimilar product to the Innovator product.

The comparability study should include an evaluation of characterization, physicochemical properties, biological activity, purity, impurities and stability.

At Protagen Protein Services GmbH we are experienced in performing comparability studies and in the analysis of biosimilar products in accordance with ICH Q6B and CHMP guidelines.

Example for a comparability study carried out at Protagen

Example: batches of a formulated monoclonal antibody; A range of analytical methods was used to show comparability:

  • Work Package 1 Structural Characterization
    • N/C terminal Sequencing
    • Peptide Mapping
    • Total Mass
    • Deamidation/ Methione Oxidation
    • Amino Acid Analysis
  • Work Package 2 Impurity Analysis
    • IEF
    • IEX
    • RP-HPLC
    • Identification of impurities by MS

Your contact for ICH Q5E compliance at Protagen Protein Services GmbH

Thomas Flad

Dr. Thomas Flad

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com