Cipla Biotec 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, Cipla BioTec aims to create a transformational impact in the way biologics will be used.
Cipla Biotec 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 at Cipla BioTec