Demonstrating product comparability for a biolpharmaceutical in a manunfacturing process or after manufacturing process change is no easy task. Comparability is the demonstration of a high degree of similarity between products produced by different manufacturing processes, equipment and/or sites, such that no adverse impact on quality, safety or efficacy occurs.
Comparability is NOT identity
Early stage development is where the foundation for assessing comparability begins, and the effects of good or poor development will carry throughout a product life-cycle. Sufficient process and product knowledge is required for reliably predicting and assessing the impact of a change and ensuring that a product will consistently meet approved specifications and standards. Efforts required to assess comparability are inversely proportional to a manufacturer’s understanding of its manufacturing process, product quality attributes, and capability of the analytical methods used. An assessment of comparability should show that products are highly similar before and after a manufacturing change occurred. It does not mean the products are identical, but that their physicochemical and biological properties are sufficiently similar to ensure no adverse impact on their quality, safety, or efficacy.
Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves.
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.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity