Creative Biolabs provides comprehensive primary structure analysis, using MS and peptide mapping for intact mass, sequence, N/C-terminal variants, and disulfide structure confirmation.
Learn More →Structure & Biochemical Characterization Services
A complete and accurate structure and biochemical characterization package is the single most important factor for a successful regulatory submission. Our service is meticulously designed to eliminate ambiguity and provide definitive data on critical quality attributes. By offering robust, high-quality characterization from the earliest stages, we de-risk your program, ensuring that your therapeutic molecule meets all necessary standards for quality, safety, and efficacy, paving a clear path toward regulatory approval.
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Introduction of Structure and Biochemical Characterization
Structure and biochemical characterization are the essential regulatory foundation for all recombinant therapeutic proteins, mandated by international guidelines to define the complete molecular profile. It combines high-resolution mass spectrometry (MS) for sequence and post-translational modification (PTM) analysis with advanced biophysical tools to confirm folding, assess solution behavior, and predict long-term stability and immunogenicity risk. This rigorous characterization is essential for minimizing downstream risk, optimizing formulation, and securing regulatory approval globally.
Find All Our Featured Services
Primary Structure Characterization
Biophysical Characterization
Creative Biolabs offers biophysical characterization of protein high-order structures using techniques like CD, DSF, DSC, and DLS, along with kinetic analyses (MST, SPR, ITC) to assess conformation and stability.
Learn More →Post-translational Modification
Creative Biolabs offers various post-translational modification (PTM) services for analyzing modification categories and sites, which are critical for studying complex cellular processes, disease diagnosis, and prevention.
Learn More →Forced Degradation Studies
Creative Biolabs offers forced degradation, subjecting pharmaceutical compounds to alkaline/acidic hydrolysis, photolysis, oxidation, humidity, and temperature stress. This reveals degradation pathways and validates analytical stability methods.
Learn More →Charge Variant Analysis
We offer charge variant analysis for antibodies using cIEF and IEX-HPLC. This service helps characterize macromolecules and understand their impact on your lead compound's function and stability.
Learn More →Size Variants Analysis
Creative Biolabs uses size exclusion chromatography to monitor and control scFv size variants (monomers, dimers, aggregates) resulting from engineered disulfide bonds, ensuring high-resolution, accurate analysis.
Learn More →Comprehensive Solutions for Biotherapeutic Challenges
CQA Identification & Regulatory Definition
We go beyond simple purity checks to precisely define the molecular attributes (e.g., specific glycosylation profiles, controlled aggregation states) that are critical to function, efficacy, and safety, ensuring your control strategy aligns with global regulatory expectations.
Comparability Study Support
Generating necessary, statistically validated data sets to bridge changes in manufacturing processes (as required by international guidelines for change management), ensuring seamless regulatory acceptance across all clinical phases without unnecessary delays.
Data-Driven Formulation Optimization
We deliver high-resolution stability fingerprints (thermal melting temperature Tm, conformational flexibility, aggregation propensity) derived from techniques like DSF and DLS to guide rational buffer and excipient selection for maximum shelf life and product stability.
Immunogenicity Risk Mitigation through Structure
By mapping PTMs and conformationally unstable regions using HDX-MS, we proactively identify areas that may generate neoepitopes, allowing for targeted engineering to reduce the potential for immunogenicity.
Validation of Complex Modalities
We verify the correct assembly, stoichiometry, and structural integrity of advanced formats like bispecific antibodies (BsAbs) and antibody-drug conjugates (ADCs), which often possess unique structural risks.
Discover How We Can Help - Request a Consultation to discuss your molecule's specific analytical requirements and de-risk your development path.
Publication
This review examines how antibody structure and dynamics inform therapeutic and vaccine design. It highlights antibodies as dynamic conformational ensembles rather than static structures, crucial for antigen recognition. Advances in computational prediction, cryo-EM, and NMR enable detailed characterization. The article covers rational vaccine strategies against evolving pathogens and protein engineering for novel formats like bispecific antibodies and single-domain antibodies, integrating structural biology with immunology for next-generation biologics.
Fig.1 The integration of structure and biophysical properties in defining IgG antibody function. 1
Why Choose Creative Biolabs?
Creative Biolabs is your strategic scientific partner, translating complex data into clear, regulatory-compliant solutions, leveraging two decades of experience to de-risk your biologic early. Our integrated multi-modal technology platform is one of the few to incorporate HDX-MS and SAXS directly into the standard workflow, giving unparalleled insight into structural dynamics and colloidal stability for optimal formulation. We guarantee commitment to regulatory standards as all methods are qualified and validated in strict accordance with international guidelines, ensuring audit readiness for critical submissions. Furthermore, we specialize in characterizing complex biologics like bispecifics, fusion proteins, and ADCs, confirming correct assembly and linker integrity.
Experience the Creative Biolabs Advantage - Get a Quote Today to secure your project's success.
FAQs
What is the most common reason for a molecule failing the characterization phase?
The most common failure points involve poor long-term stability and high aggregation propensity due to local conformational instability. Our advanced techniques are specifically designed to proactively identify and map these "hot spots" before they cause catastrophic formulation failure.
Can you analyze complex modalities like ADCs or bispecifics?
Absolutely. For ADCs, we provide precise DAR (drug-to-antibody ratio) and drug load distribution analysis via MS. For bispecifics, we use specialized SEC and native MS to confirm correct heterodimer assembly and prevent mis-pairing, which is a major challenge in these modalities.
How does the high-throughput stability screening (DSF) assist my formulation efforts?
DSF allows us to rapidly screen hundreds of buffer/excipient combinations using minimal sample volume to find the combination that maximizes your protein's thermal stability. This fast, data-driven approach dramatically reduces the empirical testing required for optimal drug formulation.
Customer Review
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Aggregation Hotspot Mapping
The HDX-MS data provided by Creative Biolabs was instrumental. It clearly identified a flexible loop in the CDR region that predisposed the molecule to aggregation, enabling us to rationally redesign the sequence and significantly improve thermal stability. - R***n H -
Formulation Optimization
We utilized their high-throughput DSF screening to test 50 excipient combinations. The rapid Tm data allowed us to quickly define an optimal, high-concentration formulation buffer, saving us months of stability testing. - J***s B
Related Services
To ensure a smooth transition from early discovery to clinical manufacturing, Creative Biolabs offers several complementary services that utilize data generated from structure and biochemical characterization:
Therapeutic Developability Assessment Service
Creative Biolabs specializes in therapeutic developability assessment to de-risk biologics pipelines early. By screening for consistent manufacturability, low heterogeneity, and stability, we reduce costs and shorten the overall research timeline.
Learn More →Binding Assay Services
Creative Biolabs specializes in high-quality binding assay services for therapeutic antibodies/proteins, delivering accurate, reliable results critical for optimizing efficacy, safety, and pharmacokinetics.
Learn More →Contact Us
Creative Biolabs offers an end-to-end characterization service, combining deep regulatory expertise with the industry's most advanced analytical platform (MS, HDX-MS, SAXS, DSF) to turn complex structural data into clear, actionable regulatory strategies. By partnering with us, you gain the rigorous scientific certainty and confidence needed to accelerate your program through development and into the clinic.
Reference
- Fernández-Quintero, Monica L., et al. "Structure and dynamics guiding design of antibody therapeutics and vaccines." Antibodies 12.4 (2023): 67. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.3390/antib12040067
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