With decades of experience in recombinant antibody development and manufacturing, we have successfully completed thousands of custom antibody expression projects. Our extensive knowledge and proven expertise in the biopharmaceutical field enable us to provide end-to-end solutions for biosimilar development, from initial discovery through preclinical research to IND applications. As the biosimilar market continues to expand globally, we leverage our state-of-the-art analytical facilities, experienced scientific team, and deep understanding of regulatory requirements to help our clients develop safe, effective, and affordable biosimilar alternatives. Our integrated approach combines rigorous analytical characterization, robust biological activity assessment, and comprehensive stability studies to ensure your biosimilar meets the highest quality standards and regulatory expectations.

Our Biosimilar Services

Physicochemical characterization

Our physicochemical characterization program ensures the structural integrity and quality of biosimilars. We conduct comprehensive analyses from primary amino acid sequences to higher order structures, including primary structure characterization, secondary and tertiary structure analysis, heterogeneity assessment, glycosylation profiling, and drug product attributes evaluation. Our state-of-the-art analytical facilities and experienced team help ensure your biosimilar meets the highest quality standards.

Biological activity characterization

Beyond physicochemical properties, biological activity is crucial for biosimilar quality evaluation. Our biological activity characterization services include both target/receptor binding assays (ELISA, SPR, cell-based binding, FcRn/C1q binding) and comprehensive bioactivity assays (cell-based neutralization, apoptosis, CDC, ADCC). These assessments are essential for demonstrating functional similarity between your biosimilar and reference products.

Stability characterization

Stability studies are critical for ensuring product quality throughout development and commercialization. Our comprehensive stability testing programs include long-term stability, accelerated stability, stress testing, photo-stability, real-time studies, and forced degradation testing. We utilize advanced analytical techniques such as HPLC, CE, LC-MS/MS, AUC, DLS, CD, DSC, and various spectroscopic methods to thoroughly characterize your biosimilar's stability profile.

In vivo non-clinical studies

Our in vivo non-clinical studies are designed to demonstrate comparability between biosimilars and reference products in relevant animal models. We provide comprehensive pharmacokinetics/pharmacodynamics (PK/PD) analysis and toxicokinetics assessment in rodent and non-rodent species. Our experts ensure proper study design, appropriate model selection, and thorough data evaluation to meet regulatory requirements.

Statistical equivalence analysis

Creative Biolabs offers robust statistical equivalence analysis to demonstrate that your biosimilar is neither superior nor inferior to the reference product. Our statisticians specialize in determining appropriate equivalence margins, sample sizes, and endpoints. We provide compliant data analysis to navigate complex regulatory requirements and quantify the totality-of-the-evidence for your biosimilar development program.

Why Choose Creative Biolabs?

• Comprehensive One-Stop Service: From analytical characterization to preclinical studies, we provide integrated solutions covering all aspects of biosimilar development under one roof
• Extensive Technical Expertise: Our team of experienced scientists brings decades of combined expertise in antibody development, analytical characterization, and regulatory compliance
• State-of-the-Art Facilities: Equipped with cutting-edge analytical instruments and technologies including mass spectrometry, chromatography systems, and advanced biophysical characterization tools
• Proven Track Record: Successfully completed thousands of antibody projects with a deep understanding of biosimilar development challenges and requirements
• Customized Solutions: Tailored study designs and flexible service packages to meet your specific project needs and timeline requirements
• Quality Assurance: Rigorous quality control systems ensuring reliable, reproducible results that meet the highest industry standards
• Cost-Effective Approach: Optimized workflows and efficient project management to accelerate development timelines while maintaining quality

With our extensive expertise in antibody development and biosimilar characterization, Creative Biolabs is your ideal partner for biosimilar development. Our integrated services, cutting-edge analytical capabilities, and experienced team maximize your chances of developing a successful biosimilar. Contact us today to discuss how we can support your biosimilar project.

For research use only. Not intended for any clinical use.