Bioconjugate & ADC Quality Control & Stability - Abzena

Bioconjugate & ADC Quality Control & Stability

Reliable methods to test your bioconjugate product.

Your commercial program benefits from Abzena’s in-house analytical expertise, technologies, and experience to deliver tailored methods for each molecule. Our capabilities support bioconjugates design, ADC design, and the development of complex antibody-oligonucleotide conjugates.

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To accelerate your path, Abzena develops, executes, and documents phase-appropriate analytical methods that ensure high-quality, well-characterized material and generate data supporting successful BLA and marketing submissions.

Using our global regulatory experience, we compile comprehensive data packages that align with international standards, ensuring compliance and smooth approval of your bioconjugate programs.

Our approach to bioconjugate & ADC quality control & stability

Our approach builds on Abzena’s expertise in bioconjugates design and ADC design, developing and qualifying phase-appropriate assays with extended characterization to deliver end-to-end analytical support.

This includes:

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Bioconjugate & ADC Quality Control & Stability Capabilities

We provide transparent and regular communications to ensure we meet your program goals and timelines.

Our capabilities include the following:

Compendial

  • Appearance (USP<790>/EP2.9.20),
    (USP<631>/EP2.2.2), (USP<855>/EP2.2.1)​
  • Osmolality (USP<785>/EP2.2.85)​
  • pH (USP<791>/EP2.2.3)​

Extended Characterization Analyses​

  • Intact Mass
    • Native intact mass
    • N-deglycosylated intact mass​
  • Reduced Subunit Intact Mass
    • Native reduced subunit intact mass
    • N-deglycosylated reduced subunit intact mass​
  • Peptide Mapping​
    • Amino acid composition
    • Oxidation, Lysine Clipping​
    • Acetylation, Sulfation, Phosphorylation​
    • Deamidation, Pyroglutamate formation
    • Glycation
  • Disulfide bond mapping​
  • Free sulfhydryl determination​
  • Glycopeptides
    • N- and O- Linked glycan site mapping
    • Glycan site occupancy
  • Released N- and O-linked glycan identity and structure
  • Quantification of Fucosylation
  • Monosaccharide analysis​
  • Sialic acid content
  • Glycan linkage analyses

Safety

  • Residual Ligand ELISA (Kit Based)
  • Endotoxin (LAL), (USP85 / EP2.6.14)
  • Sterility
  • Bioburden

Small Molecule Characterization​

  • 1D and 2D NMR​
  • Mass Spectrometry
  • FTIR
  • RP, NP, HIC and Chiral HPLC
  • GC
  • Karl Fisher
  • DSC
  • DLS

Antibody-Drug Conjugate Characterization​

  • HPLCESIMS​

Stability

Offering a full spectrum of analytical support, Abzena conducts stability studies for drug substance, drug product, and in-use testing in alignment with ICH guidelines. These studies cover bioconjugates design, ADC design, and complex modalities such as antibody oligonucleotide conjugates.

Stability-indicating assays are established early through forced degradation studies performed during process development. After stability time-point testing is complete, a final stability summary report is delivered to support clinical studies and market authorization submissions.

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Regulatory Affairs

Ensuring compliance and robust regulatory strategies, we develop tailored phase-appropriate qualification, process characterization and analytical method validation strategies.

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Process Track Record

We have developed hundreds of small molecules including high potency chemistry, payloads, linkers, payload-linkers as well as bioconjugation and Antibody Drug Conjugates (ADCs), giving us ...

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Commercial Manufacturing

Our integrated network of technical, quality, regulatory, and program management supports the delivery of your commercial manufacturing program. We offer reliable, predictable performance under cGMP ...

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Bioconjugate & ADC Quality Control & Stability FAQs

How does Abzena support bioconjugates design during quality control?

Abzena integrates bioconjugates design principles into stability and release testing to ensure molecular integrity, reproducibility, and regulatory compliance.

What role does ADC design play in stability testing?

ADC design determines how linkers and payloads behave under stress. Stability studies confirm that the conjugate maintains potency and safety throughout storage.

How does Abzena approach ADC linker design?

Our scientists apply targeted ADC linker design strategies to balance conjugate stability with controlled payload release, verified through forced degradation studies.

Do you support stability testing and quality control for antibody oligonucleotide conjugates?

Yes. Abzena performs stability and release testing for antibody oligonucleotide conjugates, ensuring they meet ICH and regulatory standards for advanced therapeutics.

Let’s move medicine forward.

The asset you’re developing right now can make a real difference for human health. Let us apply our wealth of experience to accelerate and maximize its potential.

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