- Chapter 1: Current regulatory landscape for biosimilars approval
- Chapter 2: Overview of biosimilars development
- Chapter 3: Case Studies: EU Regulatory Guidelines and how to interpret them
- Chapter 4: Analytical Comparability (chemistry, manufacturing and controls related product attributes)
- Chapter 5: Key factors that influence biosimilar in vitro and in vivo nonclinical testing strategies
- Chapter 6: Immunogenicity assessment for biosimilars: assay development, validation and interpretation
- Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars
- Chapter 8: Biosimilar monoclonal antibodies
Biotechnology Program Manager
Intertek Pharmaceutical Services, Manchester, UK
About the Author
Ashleigh Wake is the Biotechnology Program Manager at Intertek Pharmaceutical Services, Manchester, UK Ashleigh graduated from Huddersfield University (West Yorkshire, England) with a B,Sc. in Analytical Chemistry and joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. With a background in MS and a career of almost two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, PK studies and API/product characterization, CMC support analytics and ICH stability studies), Ashleigh has specialized in the design and delivery of regulatory (GXP) studies relating to the physiochemical and biological activity of biomolecules. Ashleigh is responsible for the strategic growth and technical direction of Intertek’s GMP compliant centre of excellence for biologics characterization in Manchester, UK. Intertek’s strategy has been to establish a one source solution for protein analysis relating to the requirements of ICH Q6B and biosimilar development.
Analytical Comparability (Chemistry, manufacturing and controls related product attributes)
Analytical comparability studies are needed to generate data substantiating the similarity, in terms of quality, safety and efficacy of thebiosimilar and the relevant reference medicinal product. Demonstration of comparability based on analytical data is, however, extremely complex. This Chapter summarizes the key considerations when planning and executing comparability studies covering, with examples, the strategic selection of analytical techniques, their applicability and limitations.
Analytical comparability of biosimilars
In any biosimilar development program, the availability of robust and reliable analytical methods for evaluation and comparison of the physiochemical properties, structural attributes, biological potency and impurity profiles of biosimilar to innovator are critical to the success. More so, compiling a comprehensive analytical package which meets current regulatory expectations can minimize the amount of clinical studies required, and thus reduce overall development program costs .
Demonstration of comparability