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.
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
- 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
- Intermediate precision
- Detection limit
- Quantitation limit
“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