As a CDMO providing biomanufacturing solutions to clients world-wide, we have the experience necessary to navigate ever-changing global cGMP requirements and ICH guidelines. We integrate our knowledge into every aspect of the development process, ensuring that the data generated by our analytical methods conforms to diverse regulatory specifications.
Biologics, by their very nature, are highly complex systems, influences by post-translational modifications, formulations, and various oligomerization states. In order to fully assess the overall effect of these modifications, a robust biophysical and physicochemical program needs to be implemented.
A complete biophysical characterization can address structural differences that have occurred during the manufacturing process that may result in properties that affect overall toxicity, immunogenicity and stability. Assessment from the primary structure (amino acid sequencing), PTMs (phosphorylation, glycosylation, acetylation, oxidation, etc.), secondary structure (unfolding vs folded), and overall tertiary structure are just some of the crucial steps required for a complete characterization.
In addition, the recent rise in the development of biosimilars due to patent expiration of many early biologic therapeutics has opened the door for abbreviated regulatory approval pathways. At minimum, a biosimilar characterization program should include a strong analytical package that includes protein quality and purity testing, amino acid sequencing, post-translational modifications assessment, analysis of physiochemical properties, and identification of Higher Order Structures.
You can be confident that our comprehensive suite of techniques and proven experience will provide indispensable guidance to your large molecule program, whether you are developing a novel biologic or a biosimilar. Our analytical team and process development teams are fully integrated to ensure proactive data exchange, resulting in faster testing and seamless communication of results. We invite you to discover how our capabilities can accelerate your biologic program.