Biosimilar Development
Solutions
Off the shelf fully validated assays
Proprietary fingerprinting technology (Intelli.b TM) for biosimilar antibody characterization
Potency assays
Antibody functionality testing
Immunogenicity profiling and prediction
Regulatory ready biosimilar package
Integrated Summary of Immunogenicity (ISI) document by molecule
Accelerate your Biosimilar Development
The rise of biosimilars has provided challenges and opportunities in equal measure for biosimilar manufacturers. Somru BioScience has developed a portfolio of reagents, validated assays, and solutions that will enable companies to capitalize on the biosimilar opportunity.
Immunogenicity Profiling and Prediction
The potential for biosimilars to elicit an immunogenic response has become a hot-button issue among regulators, physicians, and patients. The key to de-risking any biosimilar program is to detect potential immunogenicity early in the development. It is critical for biosimilar developers to anticipate and avoid any issues with immunogenicity. Somru’s comprehensive immunogenicity profiling and prediction solutions can help you establish an immunogenicity profile to assess similarity early in the biosimilar development process to assess.
Regulatory-Ready Package by Molecule
We have consultants with decades of experience interacting with regulatory authorities from global jurisdictions in biologics and biosimilar development. We have molecule specific regulatory documents such as non-clinical protocol, integrated summary of immunogenicity (ISI), IND submission package, and clinical protocols.
The road to biosimilarity is paved with successful immunogenicity prediction and confirmation.
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