Indian Biosimilar Company- Biosimilar Comparability Study

This client is developing high quality biologics to support, improve and save lives across the world. With a vision to be the first global biotech company to provide high quality products at affordable prices by the year 2025, our client aims to create a transformational impact in the way biologics will be used.

Project Overview

This India- based biosimilar development company required structural and physicochemical comparability data for a number of innovator and biosimilar molecules. The purpose of the study was to provide comparability data for key quality attributes and demonstrate the extent of biosimilarity to a range of reference material product.

BioPharmaSpec performed an in-depth comparability study including:

• Determination of Extinction Coefficient
• N-Terminal Sequencing
• Carbohydrate Analysis
• Imaging Capillary Isoelectric Focusing
• Molecular Weight
• SEC-MALS
• Peptide Mapping

Technical Considerations- Determination of Extinction Coefficient

An accurate determination of the extinction coefficient becomes essential when you start to consider the dosage of your product. BioPharmaSpec scientists can help you understand when a determination of the extinction coefficient of your product, rather than an experimental estimation, is required.

We use our working knowledge of ICH guideline ICH Q2(R1) to perform a qualification of the UV spectrophotometry and amino acid analysis for the product including the following parameters:

• Hydrolysis time optimisation
• Specificity
• Accuracy
• Precision
  • Repeatability
  • Intermediate precision
  • Reproducibility
• Detection limit
• Quantitation limit
• Linearity
• Range
• Robustness

Client Testimonial

“Biosimilar development is fast-paced and our requirements change on a regular basis. We appreciate that BioPharmaSpec has regional support in our territory, so that we receive timely responses to any questions we might have”- Head, Product Development and Regulatory Affairs