Biosimilar Development Services
End-to-end expertise for high-quality, cost-effective biosimilars
End-to-End Biosimilar Solutions
Comprehensive solutions across the biosimilar development workflow
Physicochemical Characterization
Comprehensive analyses from amino acid sequence to higher-order structures, including heterogeneity and glycosylation profiling, ensuring biosimilar integrity and quality with advanced platforms and expert support
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Biological Activity Characterization
Target/receptor binding (ELISA, SPR, cell-based, FcRn/C1q) and functional assays (neutralization, apoptosis, CDC, ADCC) to confirm biosimilar functional similarity with reference products.
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Stability Characterization
Comprehensive stability testing (long-term, accelerated, stress, photo, real-time, degradation) with advanced analytical platforms (HPLC, CE, LC-MS/MS, AUC, DLS, CD, DSC, spectroscopy) to ensure biosimilar quality and consistency.
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In Vivo Non-Clinical Studies
PK/PD and toxicokinetics assessments in rodent and non-rodent models to demonstrate biosimilar comparability with reference products.
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Statistical Equivalence Analysis
Robust statistical evaluation of biosimilar versus reference product, including equivalence margins, sample size, and endpoints, ensuring rigorous comparability assessment.
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Biosimilar Development Pipeline Showcasing our expertise across diverse biosimilar molecules and therapeutic areas, highlighting our capabilities in analytical characterization, cell line development, and process optimization.
Browse our biosimilar pipeline and discover tailored development solutions for each molecule.
Why Choose Creative Biolabs
Innovation-driven. Quality-focused. Client-centered
Integrated solutions from analytical characterization to preclinical support.
Decades of combined experience in antibody and biosimilar development.
Thousands of successful antibody projects with deep biosimilar know-how.
Flexible study designs tailored to client needs.
Q1: How does Creative Biolabs ensure biosimilarity with reference products?
A1：Through advanced analytical platforms, including structural, functional, and glycosylation assessments, ensuring comparability at every level.
Q2: Can Creative Biolabs support large-scale biosimilar production?
A2: Yes. Our GMP-compliant facilities enable seamless transition from pilot batches to full-scale production.
Q3: What are the main challenges in biosimilar development?
A3: Consistency, analytical similarity, and cost-efficiency. We address these with robust process design, scalable platforms, and deep scientific expertise.
Q4: Do you provide customized biosimilar development programs?
A4: Absolutely. Each project is tailored with flexible workflows, cell line strategies, and manufacturing solutions to meet client-specific needs.
Q5: Why partner with Creative Biolabs?
A5: Our one-stop model, advanced platforms, and experienced teams ensure biosimilar programs are efficient, reliable, and competitive.
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