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Analytical & Formulation
Development to Ensure ADC Quality and Stability

Xcellon Biologics provides Analytical & Formulation Development services tailored to the complexity of ADCs and bioconjugates. Our integrated approach leverages platform DSP purification to minimize free payloads and impurities, while comprehensive formulation and stability assessments confirm performance under real-world conditions. These capabilities serve as the critical checkpoints that validate product attributes and support smooth regulatory submissions.

What’s at Stake Without Robust Analytics and Formulation

ADCs and bioconjugates pose challenges that standard biologics workflows cannot fully address. Residual free payloads, unstable linkers, and aggregation can undermine safety and efficacy if not identified and controlled. 

Xcellon’s integrated analytical platforms and formulation development provide the tools to detect risks early, optimize stability, and deliver data packages that align with IND and GMP requirements. Together, analytics and formulation become the safeguard that ensures molecules remain safe, effective, and ready for clinical advancement.

What We Offer

  • Identity & structural analysis
    Conjugation site confirmation, DAR profiling, glycan mapping, thiol content, peptide mapping, disulfide bond analysis, molecular species distribution, mass analysis
  • Purity & impurity analysis
    Aggregates, fragments, free payloads, unconjugated antibodies, heavy & light chain profiling, residuals
  • Potency testing
    Binding assays, internalization, cytotoxicity
  • Stability testing
    Thermal, freeze/thaw, and serum stability
  • Safety & General Testing
    Endotoxin, osmolarity, pH & conductivity
  • Formulation development
    Buffer screening, excipient optimization, freeze/thaw tolerance, stability for long-term storage and delivery

Analytical development services validate early candidates from ADC lead selection and confirm conjugate quality during ADC development workflows. Our formulation strategies directly support bioprocess development by ensuring scalability and stability, and provide release criteria for future GMP manufacturing.

Confirm the quality attributes of your ADCs with confidence

Validate the critical quality attributes of your ADCs with precision and confidence. Leverage robust analytics to ensure safety, efficacy, and consistency. Achieve reliable results that stand up to regulatory and clinical demands.
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FAQs for Advanced Analytics & Formulation

How does Xcellon’s analytical platform address ADC complexity?
We specialize in ADC-specific testing, such as conjugation site confirmation, free payload detection, aggregation analysis, and stability profiling. These insights go beyond standard biologics assays and are critical for regulatory acceptance.
What challenges in ADC analysis do you solve that others often miss?

ADC programs frequently struggle with detecting and quantifying trace levels of free payload and degradation products. Our integrated analytical development workflows, combined with our platform DSP process, are designed to identify and control these risks early, ensuring cleaner profiles and fewer surprises during scale-up or regulatory review.

What steps do you take to ensure ADC formulations are stable?
We conduct thermal stress, freeze/thaw stability studies, while optimizing buffers and excipients. This ensures ADCs maintain integrity during storage, shipping, and clinical use.
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