Guaranteed verification of the predicted amino acid sequence using meticulously designed overlapping peptide maps combined with top-down validation. This orthogonal confirmation is critical for the precise identification of all single amino acid substitutions and sequence variants.
Primary Structure Characterization Service
Creative Biolabs delivers definitive solutions to eliminate structural ambiguity from your biotherapeutic development pipeline. We provide the certified molecular proof needed to validate your drug candidate's identity, accurately detect sequence variants, and fully localize all post-translational modifications (PTMs). Our comprehensive characterization goes beyond simple sequencing to establish the true molecular homogeneity and purity of your protein, ensuring full compliance with global standards for quality and safety documentation. This foundational certainty is non-negotiable for advancing into CMC, toxicology, and preclinical phases.
Background What We Can Offer Workflow Why Choose Us FAQs Customer Review Related Services Contact Us
Background: The Imperative of Primary Structure Certainty
The primary structure is the fundamental blueprint of a biotherapeutic, defining the precise linear sequence of amino acids. As confirmed by extensive literature, this sequence dictates the molecule's folding, stability, and therapeutic function. Any deviation, such as a PTM or sequence variant, results in a different proteoform. Our Creative Biolabs characterization service is designed to definitively resolve these variations, providing the foundational structural evidence required to support the credibility and safety profile of your drug candidate, ensuring certainty from the bench to the clinic.
Comprehensive Solutions for Biotherapeutic Challenges
| Services | Techniques |
| Intact Mass Confirmation | Native, deglycosylated, and reduced protein electrospray ionization-mass spectrometry (ESI-MS) |
| Amino Acid Sequence Confirmation | MS/MS sequencing of peptide maps |
| N- and C-terminal Variants | MS/MS sequencing of peptide map |
| N- and C-terminal Sequencing | De novo antibody sequencing |
| Disulfide Structure | Non-reduced and reduced peptide map with MS Ellman’s assay (or similar) |
Specific Deliverables and Solutions:
100% Sequence Coverage Confirmation
Comprehensive PTM Mapping & Quantification
We ensure precise localization and relative quantification of key modifications such as deamidation, oxidation, phosphorylation, and complex glycosylation profiles. Accurate PTM mapping is essential for assessing product stability, mechanism of action, and potential immunogenicity.
Structural Integrity Verification
We provide definitive confirmation of both intra- and inter-chain disulfide bond connectivity and the fidelity of terminal amino acids (N- and C-termini) using orthogonal chemical and mass spectrometry methods.
If structural ambiguity is delaying your regulatory filing, Discover How Creative Biolabs Can Help - Request a Consultation Today to discuss your specific protein characterization requirements.
Integrated Workflow: High-Resolution Mass Spectrometry and Orthogonal Methods
Our characterization workflow is a comprehensive, multi-step process designed for maximum redundancy and data certainty, utilizing complementary methods to ensure all structural details are captured and validated for regulatory submission.
Why Choose Creative Biolabs?
Creative Biolabs is a global leader in advanced biotherapeutic characterization, providing definitive, validated structural knowledge for accelerated product advancement. Our integrated orthogonal MS strategy mandates combining top-down and bottom-up mass spectrometry to ensure 100% sequence coverage and conclusive PTM localization, minimizing regulatory risk. We offer expertise in complex PTM resolution, specializing in resolving subtle oxidation or differential glycosylation patterns for a complete safety profile. All our data and reports are structured for regulatory-compliant documentation, simplifying your CMC preparation. We utilize our unrivaled problem-solving expertise for the most challenging structural puzzles.
Experience the Creative Biolabs Advantage - Get a Quote Today and see how our expertise minimizes your development risk.
FAQs
What is the minimum amount of purified protein required for this analysis?
While sample requirements can vary based on complexity, we generally recommend a minimum of 1-5 mg of highly purified protein (>95% purity).
Can Creative Biolabs characterize highly complex proteins, such as heavily glycosylated antibodies?
Yes, we optimize our workflow to map complex N- and O-linked glycans alongside the primary sequence, using enzymatic deglycosylation and specialized MS for complete structural resolution.
What if I don't know the exact sequence of my protein?
If your sequence is unknown, we recommend our specialized de novo sequencing service first. This service accurately reconstructs the entire amino acid sequence from scratch, providing the necessary reference.
Customer Review
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Exceptional PTM Localization
Using Creative Biolabs' service in our research has significantly facilitated the precise mapping of critical phosphorylation sites in our membrane protein, a task previously impossible due to challenging sample preparation and low PTM abundance. – Jn*De -
Speed and Accuracy
Their dual MS approach delivers reliable results faster than our in-house facility, drastically cutting our preparation costs and ensuring batch consistency. – Ky*Lg
Related Services
To achieve complete biotherapeutic characterization and advance your drug candidate successfully, you may also require complementary services offered by Creative Biolabs:
Sequence Liability Identification Service
Creative Biolabs offers sequence liability identification service using algorithms to foresee PTMs in antibody variable regions, providing critical insight to improve product quality and reduce downstream development costs.
Learn More →TCR Identification
Creative Biolabs offers TCR library analysis services using next-generation sequencing to identify paired TCR α/β chain sequences in human, mouse, rat, or rabbit, which is critical for tumor immunotherapy and vaccine design.
Learn More →Contact Us
Creative Biolabs offers the industry's most comprehensive and regulatory-ready primary structure characterization service. By rigorously confirming your protein's identity, sequence, and PTM profile using an orthogonal top-down and bottom-up mass spectrometry platform, we deliver the definitive data required for global regulatory success, minimizing your development risk and accelerating time-to-market.
To discuss your project's specific needs, receive a detailed protocol, and ensure your biotherapeutic is structurally validated, please contact our expert team today.
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