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Bioconjugate & XDC Purity and Stability Detection

Integrated analytical characterization for ADCs, XDCs, and complex bioconjugates — including purity profiling, DAR determination, aggregation and charge variants, and stability testing with full QC support.

Start a Project Overview Techniques
ADC & XDC Expertise
Purity & Stability Focus
Method Development & QC
Confidential & IP-Protected
Overview Critical Quality Attributes Analytical Platform Techniques Technical Notes FAQ Contact Reading

Overview

The performance of bioconjugates and XDCs (e.g., antibody–drug conjugates, protein–drug conjugates, peptide–oligonucleotide conjugates) depends on tightly controlled purity, drug loading, aggregation, and stability. Free payload, unstable linkers, and heterogeneous DAR distributions can drive off-target toxicity, poor exposure, and lot-to-lot variability.

Bio-Synthesis provides high-resolution analytical characterization of bioconjugates by combine LC-MS, HPLC / CE, light scattering, and biophysical analytics to build an integrated purity and stability profile for each conjugate — from feasibility screens through release-like testing and comparability.

Carrier / Targeting Moiety
Antibody · Protein · Peptide · Oligo
Linker & Conjugation Chemistry
Maleimide · Click · Enzymatic · Amide
Payload
Cytotoxic Drug · Dye · Oligo · Imaging Agent

Our workflows are designed to link structural attributes (DAR, sites, variants) to functional outputs (binding, potency, stability) so you can make clear go/no-go and comparability decisions.

Early to Late Stage

From feasibility screens and platform selection to CMC-ready methods and release-style testing.

Attribute-Driven Design

Focus on DAR, aggregation, charge variants, and stability as primary CQAs for conjugates and XDCs.

Documentation & Tech Transfer

Structured reporting, method descriptions, and data packages to support internal review and transfer.

Critical Quality Attributes We Target

Purity & Impurities
  • Main conjugate peak purity and related species.
  • Process-related impurities and by-products.
  • Free payload (drug, dye, linker, oligo) and residual reactants.
Drug Loading (DAR / Payload Ratio)
  • Average DAR or payload-to-protein ratio.
  • DAR distribution and sub-population profiling.
  • Consistency across lots, scales, and formulations.
Aggregation & Size Variants
  • Monomer, dimer, and high-MW aggregates.
  • Fragments / clipped species and partially conjugated forms.
Stability & Degradation
  • Real-time and accelerated stability profiles.
  • Linker–payload integrity and premature release.
  • Stress pathways: heat, pH, oxidation, light, agitation.

Bioconjugate Analytical Platform

Sample Types
  • Antibody–drug conjugates (ADCs) and next-gen XDCs.
  • Protein–drug / protein–polymer conjugates and PEGylated proteins.
  • Peptide, oligonucleotide, and peptide–oligo conjugates.
  • Nanoparticle, liposomal, and other carrier-based conjugates.
Study Types
  • Feasibility & platform comparison.
  • Purity and stability method development.
  • Forced degradation and mechanism-of-degradation mapping.
  • Comparability and lot-bridging assessments.
Readouts
  • Intact mass, DAR, and site occupancy.
  • Peak purity, aggregates, and charge variants.
  • Thermal transitions and unfolding / aggregation onset.
  • Binding affinity, kinetics, and cell-based potency.

Core Techniques for Purity & Stability Detection

We combine chromatographic, electrophoretic, mass spectrometric, and biophysical methods to build a coherent analytical picture for each bioconjugate or XDC.

Technique Primary Readout Typical Use
SEC-HPLC Monomer, fragments, aggregates Aggregate control, stability time-course, release-like testing
RP-HPLC / HIC Hydrophobic variants, free payload, DAR distribution Purity profiling, DAR species separation, residual small molecules
Ion-Exchange HPLC (IEX) Charge variants Charge heterogeneity and stability-induced changes
CE-SDS / CZE Size and charge variants Conjugated vs non-conjugated species, clipping, variant mapping
LC-MS / LC-MS/MS Intact mass, DAR, conjugation sites, degradants Identity, DAR, site mapping, linker–payload integrity, degradation
DLS / SEC-MALS Hydrodynamic size, molar mass Aggregation behavior and nano-bioconjugate characterization
DSC / nanoDSF Thermal transitions, unfolding, aggregation onset Formulation screening, stability ranking, comparability
SPR / BLI / ELISA Binding affinity, kinetics, relative potency Impact of conjugation and degradation on binding and function

Technical Notes & Study Design

Typical Workflow
  • Intake: conjugate design, payload, linker, and indication context.
  • Scout: quick purity / DAR / aggregation screens across conditions.
  • Build: focused method development around key CQAs.
  • Stress: forced degradation to map failure modes.
  • Transfer: summarized methods and data for internal or external labs.
Stability Panels
  • Real-time and accelerated temperature conditions.
  • pH, oxidative, light, and agitation stresses as needed.
  • Matrix effects (e.g., serum, plasma) for linker / payload stability.
  • Paired structural (LC-MS/HPLC) and functional (binding/potency) readouts.
Release-Like Thinking
  • Attribute-based acceptance criteria for purity, DAR, and aggregation.
  • Tracking lot-to-lot trends and comparability.
  • Clear, visual reports for decision-making and governance reviews.

Purity & DAR
  • Align LC-MS and HIC/SEC profiles so DAR species and aggregates are cross-referenced.
  • Include reference lots or unconjugated parent as controls where possible.
  • Use orthogonal methods (MS + UV/fluorescence + colorimetric assays) where DAR drives safety.
Stability
  • Start with stress that reflects real handling and storage risks.
  • Monitor both structure (mass, peaks) and function (binding/potency) at each time point.
  • Use limited early time points to quickly identify “fast-fail” conditions.
  • Map key degradation products by LC-MS to inform mitigation and specifications.

FAQ

Can you determine DAR and DAR distribution for ADCs and XDCs?

Yes. We routinely determine average DAR and DAR distribution using intact LC-MS and orthogonal HIC/SEC methods, and can track changes in DAR as a function of formulation or stress conditions.

How do you evaluate stability and degradation?

We design stress panels (temperature, pH, oxidation, light, agitation) and monitor each time point using SEC, HPLC, LC-MS, and functional assays as needed. This reveals both degradation pathways and sensitivity of key CQAs such as DAR and aggregation.

Can you work with highly potent or cytotoxic payloads?

Projects involving highly potent payloads are handled under appropriate safety procedures. We’ll review handling requirements and sample formats as part of project scoping before confirming feasibility.

Do you support comparability and lot-bridging studies?

Yes. We can run side-by-side analyses of legacy and new lots or process variants, using agreed attribute panels (purity, DAR, aggregation, charge, potency) and summarize the results in a comparability-style report.

What information do you need to start a bioconjugate analytical project?

Provide a brief description of the conjugate (carrier, payload, linker), current or planned formulation, expected dose range, and what decisions you need the data to support (e.g., candidate selection, comparability, stability claims). If you already have data or methods, sharing them is very helpful.

Can methods be transferred to our internal or partner labs?

We can provide method descriptions, system suitability criteria, and representative data to support tech transfer. If needed, follow-on support or bridging runs can be included.

Contact

Discuss Your Bioconjugate Purity & Stability Needs

Share your conjugate format, target indication, and key questions (e.g., DAR, aggregation, stability, comparability).
We’ll propose an analytical panel and timeline, then return a project outline and quote.

Request a Quote Feasibility Check Stability Study Design Comparability Package
Email: sales@biosyn.com
Phone: +1-972-420-8505
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Recommended Reading

  1. Hermanson, G. T. Bioconjugate Techniques, 3rd Ed. — foundational reference for conjugation chemistry and analytical characterization.
  2. Peters, C. & Brown, S. Analytical strategies for antibody–drug conjugates. — overview of DAR, aggregation, and stability analytics for ADCs.
  3. Clinical and nonclinical evaluation of ADCs. — regulatory perspectives on CMC and analytical expectations for conjugates.
  4. Biophysical characterization of biopharmaceuticals. — methods for aggregation, higher-order structure, and stability assessment.

Why Choose Bio-Synthesis

Trusted by biotech leaders worldwide for over 40+ years of delivering high quality, fast and scalable synthetic biology solutions.

Greetings Researchers,

Please be advised that any information, guidelines, writeups, and oral/video/graphic content on our website are intended solely as general guidelines.
It is the researcher's sole responsibility to conduct thorough research on the designs of the products intended for their experiments before submitting
their designs to Biosynthesis for review of production feasibility.
Thank you for your understanding.

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