Antibody Developability Assessment

Abzena's integrated approach to developability assessment ensures that your biologic or bioconjugate lead candidate is not only viable but optimized for success.

Developability Info Sheet

De-risking your lead candidate.

Developing a biopharmaceutical from discovery to market is costly and difficult. Many promising drug programs fail due to developability challenges, impacting timelines, budgets, and ultimately whether life-saving therapies reach patients. Abzena partners with you to deliver the right set of assays and analytics to assess the ‘developability’ of your drug candidates. We ensure the candidates you take forward have reduced liabilities and a de-risked development path.

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At Abzena, we de-risk the drug development process by assessing developability as early as possible. We have worked with hundreds of candidates and have the experience to help inform your approach and reduce project timescales by applying a parallel multiparametric evaluation approach covering specificity, functionality, safety and manufacturability.

Our full time equivalent (FTE) model provides you with a flexible way to apply the necessary expertise to your project with data guiding the best approach to select the superior drug candidate for progression to cell line development and manufacturing.

Choosing Your Antibody Developability Solution

We recognize that each biologic is unique and can tailor work packages so that you can get exactly what your project needs. Our stage-appropriate development solutions are designed to meet your specific needs:

  • Early Stage: A rapid multi-parametric assessment of multiple variants allowing candidate triaging.
  • Later Stage: A more extensive biophysical assessment of a small number of variants, with a focus on aggregation, thermal stability and forced degradation studies.
  • Biological and Functional Assessment: In-depth evaluation of function and MoA.
  • Immunogenicity and Safety: Critical assessments to ensure patient safety and minimize immunogenic risks.

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Unique Approach to Developability Assessment

The more you understand about your molecule earlier in the process, the better. Developability is fundamentally about understanding your molecule.

At Abzena we approach this by trying to answer two simple questions from the outset:

  1. Can we make it?
  2. Does it work?

To answer these questions, we combine decades of design experience together with the application of stage-appropriate assays to identify a handful of candidates with desirable properties from hundreds (or more) of initial candidates. However, developability isn’t static, with selection criteria needing to be continually refined in order to de-risk a project and move closer to that ideal drug.

Innovative Tools & Techniques

We combine advanced scientific methodologies, cutting-edge technology, and a deep understanding of biologics to deliver unparalleled developability solutions. We focus on:

Biologics Design & Optimization

Ultimately, everything leads back to getting the design of the molecule right. At Abzena, we have developed a range of innovative design and engineering solutions across a range of modalities, from traditional mAbs to bispecifics and bioconjugates.

Binding & Function

Biologics are complex molecules often with multiple mechanisms of action. For example, for an antibody, this could be both target-driven (via the Fv) and effector mediated (via the Fc), and so understanding the mode of action of a biologic provides critical insights into a drug’s potency, efficacy and safety.

 

 

Immunogenicity & Safety

We are committed to understanding both the immunogenicity and safety of biologics and bioconjugates. For this reason, early prediction and mitigation strategies to reduce the risk of both are integral to our approach to developability. To assist with this, we utilize multiple platforms ranging from our high throughput in silico MHC Class II prediction algorithms (iTope-AI) through to our PBMC-based immunogenicity risk assessment assays such as EpiScreen® 2.0 and whole blood cytokine release assays to look at safety.

Manufacturability

A biologic therapeutic candidate is only as good as it is stable. That is why we put so much weight on in-depth analytics. From the beginning where we look at the sequence for potential liabilities through to later stages where we perform studies that stress the molecule for potential weaknesses, we’re continually looking to identify candidates that have the desired manufacturability profiles. Furthermore, by understanding how the drug will be used, for example understanding route of administration and dosing, we can ensure molecules have the appropriate properties.

Partner with Abzena to Advance Your Biopharmaceutical

Abzena is dedicated to transforming science into life-saving therapies. Our integrated approach to developability ensures that your biologic or bioconjugate is not only viable but optimized for success. By continually refining our selection criteria and asking the right questions early, we de-risk projects and move closer to developing ideal drugs.

Connect with our team of experts today to learn how we can help to de-risk and streamline your asset so that you can start smart and finish fast on your journey from the lab to the clinic.

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Info Sheet: Antibody Humanization Technology

Composite Human Antibody™ (CHAb): Advanced Antibody Humanization - Abzena

Take your project to the next level with our Composite Human Antibody™ (CHAb) Technology. Our extensive experience in antibody development enables us to anticipate potential challenges and design innovative solutions. We offer personalized strategies to align with your goals, ensuring the development of safe, effective, and high-quality therapeutic antibodies.

Download our info sheet today and contact us to learn how our Composite Human Antibody (CHAb) technology can transform your humanization project by minimizing immunogenicity and ensuring optimal developability for clinical success.

Download Info Sheet

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Antibody Development - Abzena

Let’s move medicine forward.

The asset you’re developing right now can make a real difference for human health. Let us use our wealth of experience to deploy the best technologies, shorten lead times and implement effective risk mitigation strategies.

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