Validation of Safety and Efficacy for Autoimmune Diseases

Creative Biolabs has hugely experienced analytical specialists working alongside our teams, which provide expert advice and an enormous breadth of drug safety and efficacy validation for our global customers. Our scientists will ensure your antibody drugs to be appropriately developed and validated to meet all regulatory requirements for our customers all over the world.

Understanding the action mode of the antibody drugs is essential for considering the strategy for safety and efficacy validation both in the characterization and the comparability study. Antibody drugs exert their action by various mechanisms ranging from simple binding to antigen, which alone mediates the clinical effect, to binding antigen and mediating one or more immunobiological mechanisms that combine to produce the overall clinical response. These immunobiological properties may play a role in the mechanism of action and/or have an impact on product safety and efficacy. Therefore, the inherent complexity of therapeutics like antibodies necessitates a comprehensive analysis program to ensure safety, efficacy, and quality.

Validation of Safety and Efficacy at Creative Biolabs

Creative Biolabs is one of the well-recognized experts who are professional in applying our advanced platforms for a broad range of drug discovery projects. Our drug validation platforms can contribute to assessing the safety and efficacy of drugs for autoimmune diseases by analyzing preclinical studies in both in vitro and in vivo models. Our validations and method development studies are done thoroughly with a process that has been proven effective and compliant.

For safety analysis, the nature, incidence, and exhibition of any grade adverse events can be evaluated. Overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) can be calculated for efficacy analysis. Creative Biolabs offers comparative safety data and new drug-specific safety findings depending on the type and severity of safety issues for the reference products. Our experts, based in compliant laboratories, can evaluate each antibody drug, conduct tailored assay development, and ensure that each validation is optimized to suitably determine the safety and efficacy of these drugs. Through efficient management and proactive communication, we will help you to achieve your safety and efficacy validation goals over your drug development life cycle.

Experts in Creative Biolabs, who are considered thought-leaders in the drug development for autoimmune diseases, have worked on many drugs helping our global clients understand the safety and efficacy of their antibody products. If you would like to know more about our services, please contact us for more detailed information.

For Research Use Only | Not For Clinical Use