Biosimilar Development2022-11-15T15:18:54-05:00

Biosimilar Development.

Comprehensive Comparability Analysis of Biosimilars to Reference Biologicals.

Development of a biosimilar follows stringent standards to engineer a molecule that should be indistinguishable from the reference biologic. Rather than determining and establishing the product’s clinical efficacy, the regulatory requirement for biosimilars is to demonstrate that it is highly similar to the reference biologic in terms of quality characteristics, biological activity, safety and efficacy.

Next generation protein sequencing (NGPS) and proteomics can initiate and facilitate the comprehensive comparability analyses – a requirement from regulatory bodies (FDA BCPI Act; EMA Directive 2001/83/EC) – between biosimilars and their respective reference biologics. Determining the protein sequence of the reference biologic permits comparative characterization of the structure and performance of the biosimilar, while proteomics techniques can provide insight into the physicochemical and biological properties of the biosimilar.

Services for Biosimilar Development.

We support the characterization process for biosimilar product development. Contact Us to discover how we can help with your biosimilar development application.

 

de novo mAb Sequencing

Obtain the protein sequence for the marketed mAb therapeutic as a foundation for the development and characterization of the biosimilar product.
Explore REmAb

Comparability Analysis of Sequences

Identify sequence variations and demonstrate similarities/differences between the biosimilar and the reference mAb with peptide mapping.
Explore MATCHmAb

Epitope Mapping

Examine or validate biological targets of the biosimilar and reference mAb by characterizing their antigenic epitopes.
Explore HDX-MS

Binding Kinetics

Obtain insight into the physicochemical properties of the biosimilar and reference mAb by characterizing the antibody-antigen binding kinetics.
Explore SPR Analysis

Recombinant Antibody Expression

Compare structure and performance of the expressed biosimilar against the reference mAb in a streamlined workflow combining proteomics and recombinant expression.
Explore Antibody Expression

Application Publications.

Combined Analytical Assays for the Characterization of Drugs Binding to Human IgE: Applicability to Omalizumab-bearing Biosimilar Candidates Assessment

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To develop robust mAb biologics, it is vital to fully characterize the protein, including its primary sequence, mutations, and important post-translational modifications

“We’re focused on coupling cytokines with a highly engineered VHVL of an antibody. So by sequencing the antibodies with Rapid Novor we are able to pull out the CDR to graft them into our platform and test in vitro and in vivo.”

Pavel Khrimian – Co-founder and CBO, Deka Biosciences

Talk to Our Scientists.

We Have Sequenced 9000+ Antibodies and We Are Eager to Help You.

Through next generation protein sequencing, Rapid Novor enables reliable discovery and development of novel reagents, diagnostics, and therapeutics. Thanks to our Next Generation Protein Sequencing and antibody discovery services, researchers have furthered thousands of projects, patented antibody therapeutics, and developed the first recombinant polyclonal antibody diagnostics.

Talk to Our Scientists.

We Have Sequenced 9000+ Antibodies and We Are Eager to Help You.

Through next generation protein sequencing, Rapid Novor enables timely and reliable discovery and development of novel reagents, diagnostics, and therapeutics. Thanks to our Next Generation Protein Sequencing and antibody discovery services, researchers have furthered thousands of projects, patented antibody therapeutics, and ran the first recombinant polyclonal antibody diagnostics

Talk to our scientists. We have sequenced over 9000+ antibodies and we are eager to help you.