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Incomplete molecular characterization leading to regulatory setbacks and delayed approvals
Difficulty distinguishing and quantifying subtle structural variants that impact safety and efficacy
Limited ability to correlate physicochemical properties with functional performance and stability
Inconsistent analytical methods and data gaps across development and manufacturing stages
Our Core Platforms
Our characterization capabilities are organized into four integrated analytical modules, each targeting a distinct level of biologic structure. These platforms can be engaged individually or combined for a complete molecular understanding.
Disulfide bond mapping, scrambling analysis, and free thiol quantification
Phosphorylation, acetylation, methylation, and other low-frequency modifications
Application Scenarios
Our Structural & Physicochemical Characterization platform supports a broad range of biologic products and development objectives:
Therapeutic Monoclonal Antibodies: Complete primary sequence confirmation, glycan profiling, HOS comparability, and biosimilar analytical similarity assessment
Recombinant Proteins and Peptides: Molecular weight verification, PTM site mapping, batch-to-batch consistency evaluation, and forced degradation monitoring
Vaccine Antigens and Viral Vectors: Structural integrity evaluation, stability-indicating assays, critical quality attribute identification, and release testing support
Cell and Gene Therapy Products: Vector protein characterization, impurity profiling, capsid structural analysis, and regulatory filing support
Why Choose Profacgen?
Integrated Multi-Level Characterization: We unify primary, higher-order, and physicochemical analyses into a single, coherent program that eliminates data silos and interpretation gaps.
Regulatory-Aligned Methodologies: Our analytical platforms are designed and qualified to meet ICH Q6B, FDA, and EMA expectations for structural characterization, comparability, and release testing.
Advanced Instrumentation and Expertise: We deploy state-of-the-art mass spectrometry, spectroscopy, and chromatography systems operated by scientists with deep biologics analytical experience.
Customizable and Stage-Appropriate Solutions: From early candidate selection through late-stage commercialization, we tailor characterization scope and intensity to your specific program milestones.
Whether you require targeted analysis of a specific structural attribute or a comprehensive characterization package for regulatory submission, our Structural & Physicochemical Characterization platform provides the data integrity and scientific rigor required to advance your biologic program.
Explore our analytical modules above or contact us to discuss a tailored characterization strategy for your molecule.
Online Inquiry
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