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
The client required structural and physicochemical comparability data for a number of cell clone products of a biosimilar monoclonal antibody, in order to support key development decisions.
The following analyses were performed by BioPharmaSpec, at different phases of the development programme:
- Oligosaccharide Population Analysis
- Imaging Capillary Isoelectric Focusing
- DSC- Determination of Melting Temperature (Tm)
- Molecular Weight of the Light and Heavy Chains
- CE-SDS
- SEC-MALS
- Peptide Mapping
- Primary sequence analysis
Technical Considerations- Primary de novo Amino Acid Sequencing
Confirmation of primary amino acid sequence at the protein level is essential for the development of a biosimilar, where you must ensure that the primary protein sequence is identical to that of the innovator product.
BioPharmaSpec scientists designed the first successful strategies for protein sequencing and have remained at the forefront of this technique for the last three decades. We use our expert knowledge of the methodologies and instrumentation applications to provide our clients with quality sequence data that they can rely on.
In order to determine the primary amino acid sequence of your biopharmaceutical, BioPharmaSpec perform the following analyses:
- On-line LC/ES-MS/MS and/or MALDI-TOF/TOF analysis, as appropriate, and analysis of the peptides obtained from multiple digests of the product.
- As MS-based sequencing may not distinguish the isobaric amino acids Ile and Leu, peptides containing these amino acids are purified and further subjected to Automated Edman Degradation (N-terminal sequencing) in order to identify the Ile/Leu positions unambiguously.
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
Need biosimilar comparability?
Please contact our scientists if you would like to discuss appropriate characterization strategies for your product.