Biologics Analytics & Bioassays - Abzena

Biologics Analytics & Bioassays

Reliable, rapid bioassays and analytical method development.

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Early, reliable bioassays that de-risk your product.

Whether you need to answer a stand-alone question, or your conjugation, humanization or cell line development program requires complementary bioassays or analytical method development, Abzena can provide you with the optimal solution and rapid data to move your program forwards.

 

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Our approach focuses on developing phase-appropriate bioassays for assessment of potency, efficacy and safety, giving you insight to make informed decisions during your drug development journey.

We also develop and fully document the phase appropriate analytical methods necessary to produce high-quality, well-characterized material and the rapid data needed to support successful IND and marketing applications.

For each or both services, your program will benefit from our wealth of knowledge and expertise across a diverse range of modalities including bioconjugates & ADCs, multi-specifics, fusions, fragments, agonist, and antagonist activities and more.

Extensive Panel of Target & Effector Cells

To help understand your molecule in detail, we have an extensive panel of both target and effector cells together with a substantial in-house PBMC cell bank. Complementing this is a broad choice of bioassay platforms including:

  • Luminescence, fluorescence, absorbance plate-based assays
  • BiacoreTM
  • Flow cytometry
  • Incucyte® live cell imaging (and other microscopy techniques)
  • Cytokine analysis (Luminex®, FluoroSpot)
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LabZient™: Rapid Analytical Data

Developed to increase your biopharmaceuticals chances of clinical success, LabZient™ is our unique, next-generation analytical solution. Expedite your program to IND with LabZient™. To learn more, or access our latest LabZient™ info sheet, click the button below.

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GMP Cell-Based Potency Testing for Biologics

Bioassays & Analytics

GMP cell-based potency assays quantitively measure the biological activity of a biopharmaceutical drug. For Antibody-drug conjugates (ADCs), these assessments are used to measure the cytotoxicity of the payload for both GMP product release and during stability testing. These important assays enable us to provide our customers with reliable data on their drug’s potency, which is essential for regulatory submissions.

By offering GMP cell-based potency assays alongside our robust suite of bioassay capabilities that include developability, characterization, mechanism of action (MOA) studies, and immunogenicity, we are able to provide our customers with a more comprehensive, streamlined, and cost-effective way to access critical data even faster.

What sets our bioassay and analytical development services apart?

  • State-of-the-art laboratories with an extensive range of biophysical equipment and capabilities
  • Extensive experience in supporting manufacturability, developability assessment, and lead candidate selection for a wide range of modalities including mAbs, bispecifics, and bioconjugates
  • Expertise in protein characterization and proteomics provide an in-depth molecular understanding, including identification of post-translational modifications and degradation sites
  • Analytical capabilities to support bioconjugate programs including DAR and conjugation site identification as well as serum stability and payload release studies and free payload analysis
  • Analytical capabilities to support CLD programs, including determination of critical or product quality attributes and reference standard characterization
  • Significant immunoproteomics expertise supports the de-risking of potential immunogenicity of biotherapeutics and or to enhance vaccine development
  • We offer a full range of phase appropriate solutions, from simple bioassays with high accuracy and precision to complex co-culture primary cell models for mode of action studies
  • Comprehensive suite of functional bioassays with over 30 off-the-shelf assays, as well as tailored solutions to answer specific questions that off-the-shelf assays may not be able to answer
  • Investigative approach to provide data early in the development process allowing informed decision making on whether to progress or kill a program, translating to significant time/cost savings
  • Extensive experience with a wide range of modalities, including mAbs, ADCs, AOCs, bispecifics and immunomodulators
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Antibody Discovery

Our comprehensive suite of bioassay solutions includes both established assays and custom assay development matched to your individual program needs. Our bioassay services include:

Target validation

  • In vitro gene/protein expression
  • Functional analysis – Assessment of signalling pathways and cell health
  • Biomarker profiling – Surface markers, cytokine production

Hit-to-lead screening

  • Target binding and affinity – ELISA, BiacoreTM, flow cytometry
  • Functional activity – Reporter assays and primary cell assays

Antibody Design & Development

Specificity & tissue profiling

  • On-target binding to cell lines or primary disease tissue
  • Off-target binding to primary immune cells or normal tissue
  • Polyspecificity assessment

Mode of action

  • Ligand binding and competition
  • Internalisation and trafficking
  • Viability assessment – 2D/3D viability assay, cell cycle arrest, apoptosis, bystander effect, co-culture cell killing
  • Gene and protein knockdown
  • Fc effector function – ADCC, ADCP & CDC
  • MLR & superantigen proliferation and cytokine analysis
  • PK & PD assessment

Immunogenicity & Safety assessment

  • Immunogenicity risk assessment of proteins using:
    • Episcreen® 2.0 time course assay
    • Episcreen® 2.0 DC:T cell assay
  • Identification of immunogenic sequence “hot spots” using:
    • In silico assessment by iTope-AI
    • MHC Class II associated peptide proteomics (MAPPs)
    • Episcreen® 2.0 T cell epitope mapping
  • Safety assessment of proteins with potential to induce cytokine storm
    • Cytokine Release Assay

Access is latest info sheet on our newly enhanced Episcreen® 2.0 platform to learn more.

Immunogenicity Assessments
EpiScreen® 2.0 DC:T Cell Assay EpiScreen® 2.0 MAPPs: MHC Class II Associated Peptide Proteomics EpiScreen® 2.0 T Cell Epitope Mapping EpiScreen® 2.0 Time Course T Cell Assay Episcreen® 2.0 Cytokine Screen™ Custom Immunology Assays

Biologics Manufacturing - Potency & Batch Release

Manufacturing – Potency & Batch release

  • Development of ELISA or cell-based binding assays
  • Development of MoA-reflective potency assays
  • Assay validation and GMP testing
“I had the pleasure of working with Abzena’s Cambridge, UK team on a variety of in vitro pharmacology projects, ranging from cell-based assays to Biacore kinetic analysis. I found the team to be professional, reliable, and excellent partners. Given the virtual nature of the company I work for, we rely on strong partnerships in order to produce quality data to allow us to make strategic program decisions. The Abzena team was instrumental in providing timely, high-quality data that impacted our decision-making. I would highly recommend this team for all your preclinical pharmacology needs.”

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About LabZient™

LabZient™ sets a new standard in the field of biopharmaceutical analysis offering a cost-effective, efficient, and scientifically sound path to clinical trial readiness.

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LabZient™ Info Sheet

Learn how LabZient™ enables a rapid path to Investigational New Drug (IND) applications by reducing the extensive testing traditionally necessary.

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LabZient™ Q&A Blog

Eric Miller, one of our Senior Analytical Leaders offers his insights into how LabZient™ streamlines and de-risks the path to IND applications and beyond.

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Formulation Development

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Let’s move medicine forward - Abzena

Partner with us

From bench to bedside, we are dedicated to ensuring quality excellence in everything we do.

We adapt our approach to shorten lead times and develop risk mitigations strategies to ensure your overall success in delivering vital medicines to patients.

 

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