Bioconjugate & ADC Analytical Method Development - Abzena

Bioconjugate & ADC Analytical Method Development

Reliable analytical methods to characterize your bioconjugate product.

Accelerate your bioconjugate program using rapid bioanalytical data.

Accessing rapid bioanalytical data is crucial to meeting milestones faster in bioconjugate development. At Abzena, your bioconjugate product development program will be accelerated by leveraging our extensive in-house analytical capabilities, technologies, and 20+ years of knowledge to deliver methods tailored to your molecule of interest.

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Accelerating your path to the clinic, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND and marketing applications as you move forwards to commercialization.

Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies. We provide transparent and regular communications to ensure we meet your program goals and timelines.

Our Approach

Our approach focuses on developing and qualifying phase appropriate assays for a spectrum of safety, potency, purity, identity, and extended characterization that enable end-to-end support for:

  • Design and developability
  • Formulation development
  • GMP manufacturing
  • Bioconjugation
  • Release and stability testing for GMP material
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We are moving medicine forward.

60+ average number of method qualifications per year.

6 weeks or less average method qualification time.

20+ years of experience delivering rapid bioanalytical data.

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Leverage our global expertise

Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging state-of-the-art instrumentation and a molecule-specific, customized approach to method development, qualification, and testing. Methods can be developed de novo or transferred in from external laboratories.

By understanding your molecules’ attributes, we support future development activities with customized characterization assays. Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports cell line, process, and formulation development, and/or bioconjugation.

Explore Our Biologics AMD Capabilities

Bioconjugation & Analytical Method Development Capabilities

Our capabilities utilized to support bioconjugation 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)

Safety

  • Residual Ligand ELISA (Kit Based)​
  • Endotoxin (LAL), (USP85 / EP2.6.14)​
  • Sterility
  • Bioburden
  • GMP Cell-Based Potency Testing

Small Molecule Characterization

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

Antibody-Drug Conjugate Characterization​

  • HPLCESIMS

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Structural characterization and purity

  • Determination of drug loading (DAR)
  • Analysis of conjugation site
  • Analysis of ADC homogeneity
  • Chromatographic and spectroscopic purity
  • Quantification of residual unconjugated drug
  • Aggregation profile

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Analytics & Bioassays

We focus on giving you all of the rapid insight needed to help make informed decisions earlier during your biconjugate development journey.

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Formulation Development

We develop comprehensive formulation development packages including stable liquid and lyophilized formulations for bioconjugates.

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Process Development & Optimization

Our experts collaborate together to develop quality, commercially viable processes ensuring seamless scale up through to commercial launch.

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Let’s move medicine forward - Abzena

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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