Comprehensive Analytical Services for Biologics & Bioconjugates - Abzena

Comprehensive Analytics for Biologics & Bioconjugates

Abzena’s analytics platform combines decades of expertise, phase appropriate methods, and global regulatory support to de-risk biotherapeutic and bioconjugate development.

Analytics Info Sheet

From high throughput screening through GMP release, we deliver the data and documentation your biologic program needs to succeed.

Analytics are intricately linked with assessing a large molecule’s biophysical properties as well as understanding its broader manufacturability to ensure that the target product profile (TPP) can be successfully achieved in the clinic. However, developing robust analytical methods in the preclinical setting when there’s limited information about a therapeutic’s properties and evolving regulatory expectations, requires balancing speed with data quality. Abzena are leaders in providing comprehensive analytical services for biologics and bioconjugates that can de-risk and accelerate your program.

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Variations in sequence, post-translational modifications (PTMs), higher order structure, and conjugation chemistry can introduce critical liabilities including aggregation, fragmentation, oxidation, deamidation/isomerization, or glycoform heterogeneity, which can compromise safety, efficacy, and manufacturability. If these liabilities are not uncovered early on in development, later stage failures can occur due to insufficient analytical insight, which can delay IND filings by months and incur millions of dollars to re-work.

To address these risks, Abzena develops, executes, and documents the phase-appropriate analytical methods necessary to produce high quality, well-characterized material and the data that underpins both early-stage R&D as well as supporting successful IND, FDA, EMA, and PMDA submissions. By leveraging rapid analytical data at each stage, we accelerate and improve your biologic’s path to the clinic and commercialization.

Our Analytics Approach

Our Analytics Approach - Abzena

Abzena’s integrated analytical framework combines:

  • The use of phase-appropriate analytics from discovery through GMP release
  • Method transfer and analytical technique bridging to ensure continuity across labs and increasing scale
  • Fit-for-purpose qualification and validation per ICH Q2(R1/R2) and ICH Q14
  • Regulatory submission support with fully documented protocols and data packages for FDA, EMA, and PMDA

Step-By-Step Approach Advantages

Step-By-Step Analytics Approach - Abzena

  1. Techniques such as LC-MS/MS allow the identification and mapping of potential sequence liabilities such as oxidation, deamidation, proteolytic-cleavage sites, and other instability hotspots. Early identification of these sites provides scope for sequence re-engineering prior to final candidate selection or risk mitigation through e.g. formulation adjustment
  2. Facilitates effective candidate selection by coupling manufacturability-focused stress studies with biophysical profiling—aggregation, fragmentation, and charge-variant analysis—to generate objective developability scores that identifies leads most likely to express efficiently and maintain high-yield and purity in GMP manufacturing
  3. Establishes robust critical quality attributes (CQAs) using biophysical and compendial/GMP release assays
  4. Supports regulatory milestones with transfer-ready methods and submission-ready documentation

Technical Specifics

While each development phase has unique analytical demands, Abzena’s technical platform delivers consistent, high-quality data through a combination of orthogonal, high throughput and stability indicating assays. Our capabilities ensure that every critical quality attribute is measured accurately and reliably.

Platforms

  • UPLCSEC, UPLCCEX, UPLCHIC with UV, fluorescence, MALS, and RI detectors for size, charge, and hydrophobicity profiling
  • Thermal ramping using DSF and SLS for assessing Tm, Tagg, and Tonset
  • Capillary electrophoresis (CE-SDS, icIEF) for high resolution heterogeneity assays
  • High resolution Mass Spec (QTOF, QQQ) enabling intact/subunit analysis and bottom-up peptide mapping LCMS/MS for residue level site identification
  • DLS and SEC-MALS for hydrodynamic radius and absolute mass of multimers and nanoparticles

Screening Tools & Assays

  • High throughput screening assays for rapid thermal ramping, aggregation, charge variant, and drug-to-antibody ratio (DAR) profiling
  • Glycan analysis: enzymatic N-glycan release and HILIC-MS; monosaccharide quantitation (e.g., sialic acid) by acid hydrolysis
  • Peptide mapping using LCMS/MS to localize PTMs for de-risking during lead optimization as well as determination of conjugation sites during bioconjugation
  • Compendial and GMP release assays validated under ICH Q14 for purity, potency, identity, and stability
  • Spectroscopic methods (FTIR, Raman, and SoloVPE) for structural verification and concentration determination
  • Stability indicating assays: forced degradation (thermal, pH, oxidative) studies with orthogonal readouts (DLS, SECMALS, peptide mapping) to confirm assay specificity and stability indicating capability

Reference Standards and System Suitability

  • In house qualification of primary and secondary reference materials, demonstrating stability and suitability across method transfers
  • System suitability tests and ruggedness evaluations (analyst, instrument, day variability) ensure routine assay reliability

Residuals and Impurity Testing

  • Host cell protein ELISA, endotoxin testing, residual solvent, and leachables screening to ensure the safety and purity of biotherapeutics and conjugates

Data Reporting and Analysis

  • Automated data processing pipelines with audit trails, outlier flagging, and trend report generation
  • Submission ready reports in eCTD compatible formats for seamless regulatory filing

Capacity and Track Record

  • >20+ years of experience delivering rapid analytical data
  • 60+ method qualifications per year with average qualification time ≤ 6 weeks
  • Global multi-site operations (Cambridge, UK, Bristol, PA, San Diego, CA) enabling surge capacity and 24/7 support

Risk Mitigation

  • Early detection of aggregation, fragmentation, oxidation, or deamidation to guide sequence and formulation optimization
  • Conjugation site occupancy and DAR analysis ensure batch-to-batch consistency for ADCs and bioconjugates
  • Higher-order structure assessment (DLS, SECMALS) confirms multimeric assembly and nanoparticle integrity to prevent formulation failures

Stage-Appropriate Workflow

Discovery and Lead Selection

Intact/subunit MS and peptide mapping localize PTMs, allowing subsequent re-engineering, while phase appropriate screening cascades flag candidates with undesirable CQAs, enabling data-driven selection and molecular design decisions.

Early-Stage Development:

Intact mass analysis can confirm product identity and expression of the correct molecule. Additionally, it will help to identify impurities such as splice variants and degradation products. Product glycoforms can be established not only from the intact mass data but also from glycoprofling and monosaccharide composition analysis data.

IND Enabling and Manufacturing

Extended characterization—mass spectrometry analysis (intact mass, peptide mapping, free sulfhydryl quantitation, disulfide bridge mapping, glyco profiling), compendial/GMP release assays, DLS and SECMALS—establishes reference standards; method transfer and validated release methods under ICH Q14 support FDA, EMA and PMDA submissions.

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