Harmonisation Guidelines for Pharmaceuticals for Human Use
Guidelines for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
The mission of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" is to achieve greater harmonization for the pharmaceutical industry of Europe, Japan and the US and the business world as a whole. The goal is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. To achieve this many guidelines were developed that can be downloaded from the ICH website.
The ICH Q6B guidelines on physicochemical properties cover biochemical techniques to assess the degree of molecular homo- and heterogeneity of biomolecules such as therapeutic protein drugs. The use of structural analyses is recommended that can include the assessment of any changes in secondary, tertiary, quaternary and higher-order structures. These dedicated guidelines are described in the ICH Q6B document. The guidelines suggest that relevant biological assays can be used to confirm or support conformational equivalency between two products if higher-order structural information cannot be obtained.
All manufacturers of peptide, protein or other biosimilar products are encouraged to provide meaningful and insightful bioassay data. The data should highlight or confirm the absence of any effects indicating any changes in process. Selecting the proper assays should allow the confirmation of higher-order structures for all products. Non-clinical and clinical studies may be necessary in cases where physicochemical or biological assays are not sufficient.
For antibodies and antibody-based products, a manufacturer should confirm that specific attributes of the products are maintained and are comparable by using the appropriate assays. For example, since it is known that small differences in glycosylation and deglycosylation are known to have immunogenic consequences, a special interest of the conference is the development of guidelines for biosimilars and interchangeable biologics.
Purity, impurities and contaminants
The guidelines on purities, impurities and contaminants are intended to ensure that isoforms and degradation products are detected. The guidelines recommend the use of a combination of analytical procedures to allow confirmation of the purity profile for the product or products and to guaranty that it has not changed. It is the duty of the manufacturer to take measures to prevent the formation of contaminants or to identify and characterize them by using appropriate methods.
Link to ICH website; http://www.ich.org/)