Developability Assessment: the Derisker

The more you understand about your molecule earlier, the better. We help you start smart and finish fast with our stage-appropriate developability assessment solutions for complex biologics and bioconjugates.

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Drug development is a balancing act. Designing a drug means balancing everything we’d want in a perfect candidate with everything we face in reality.

Drug development is inherently risky. Success is not guaranteed, and the rate of failures is high. To work towards the ideal drug, we have to overcome a host of challenges and avoid falling into the ‘valley of death’, where drugs fail between discovery and an effective proof of concept (POC).

To balance the scales more favorably and mitigate some of the biggest risks in drug development, it is essential to gather as much information about a drug candidate early on to make better, more informed decisions further down the line. This is where the idea of ‘developability’ comes in: developability refers to the assessment of a drug candidate’s properties and potential risks to determine its suitability for further development. Developability helps balance the scales of an ideal drug candidate vs the challenges of reality.

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The drug development balancing act

Designing a drug means balancing all the desirable features of a perfect candidate with the reality of pressures faced during discovery and development.

  • Ideal drug: Stability, Efficacy, Safety

    • Reality: Costs, Time, Feasibility

To add context, it’s estimated that for each new drug to go from idea to being approved for clinical use, it takes over 10–15 years with an average cost of over $1–2 billion.​

$1-2 billion

Average cost

10-15 years

Average time

90%

Rate of failure

Source: (Sun D et al. (2022) Acta Pharm Sin B. Jul;12(7):3049-3062)

To work towards that ideal drug we have to overcome a host of challenges and avoid falling into the ‘valley of death’, where drugs fail between discovery and an effective proof of concept at Phase II.

Common reasons for attrition​

  • Lack of clinical efficacy
  • Unmanageable toxicity / safety / immunogenicity
  • Poor drug-like properties​
  • Lack of commercial needs and poor strategic planning​

Impact of attrition​

  • Delays in the delivery of life-changing medicines
  • Development delays lead to unplanned costs​
  • Potential to damage investor confidence and a company’s ability to secure future funding

How do Abzena allow you to start smart and finish fast? Read more below or contact our team of experts today to learn more about our developability assessment approach.

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Derisking drug development through developability​

Our approach to Developability Assessment helps to mitigate risks by providing a thorough understanding of your molecules. ​

Developability Assessment aims to:​

  • Identify risk factors early in the development process
  • Provide scope to fix, reduce or manage liabilities
  • Reduce the likelihood of major issues arising at later stages of development where the cost of failure is significantly higher​
  • Ensure the selection of the best drug candidate for development
  • Reduce financial risk & provide investor confidence

At Abzena, we understand that assessing developability represents a strategic solution that guides the decision-making process​.

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Drug Developability: Two simple questions

Derisking drug development through developability​ - Abzena

Balancing the scales of an ideal drug candidate vs the challenges of reality is complex. To overcome that, we ask two simple questions:

1. Can we make it?

  • Can we make the drug as a stable compound in the required form and quality to treat patients?
  • Can we make the drug at scale, with an acceptable cost, within acceptable timeframe, with enough doses to treat the patient population?

2. Does it work?

  • Does the drug do what we expected it to do – is there a predictable mechanism of action?
  • Does the drug have the desired efficacy?
  • Is the drug safe for the target patient population?

Developability represents a holistic approach to answering ​those two fundamental questions. Abzena’s Developability Assessments identify and manage risk early in development to reduce major cost, quality and time issues at later stages of manufacture and clinical evaluation.

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Derisking through developability

By asking, “Can we make it?” and “Does it work?” right from the start, we can begin to whittle down candidates from hundreds to a handful. From there, we can keep refining the selection criteria, continually derisking a project and moving closer to that ideal drug.

Derisking drug development through developability​ - Abzena

Discovery

Hit generation followed by high throughput in silico and in vitro screening to screen out candidates with undesirable properties.

Lead Design & Selection

Candidates are designed and engineered to remove undesirable properties and introduce desirable properties.

Lead Characterization

Detailed biological and biophysical characterization of a small panel of molecules in order to select a lead candidate for progression.

Full Development & Manufacture

Comprehensive understanding of a single candidate and capability to develop, manufacture and deliver your drug for both clinical and commercial scale.

The steps to success

Developability Assessments are critical to enabling effective lead candidate selection. In summary Developability offers:

  • Establish a clear vision from the outset of where the molecule is heading
  • Anticipate early on what the key risks of any project may be
  • ​Developability is an essential part of Drug Discovery and should be applied continually​
  • ​Developability requires a holistic view of your molecule – do not focus on just one attribute​
  • ​Time and money spent wisely early on Developability can save substantial costs at later stages if a molecule fails due to avoidable issues​
  • ​It’s never too late to check your molecule

Now you know more about what goes into the developability process at Abzena, what exactly can you get? Well, we offer both flexible pre-defined packages, or tailored à la carte options so you can get exactly what your project needs and address specific questions.

Are you ready to derisk and develop your next biologic or bioconjugate with us? Get in touch and let’s work together to move medicine forward faster.

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Developability FAQs

What is "developability" in the context of biologics and bioconjugates?

Developability refers to the likelihood that a biologic or bioconjugate can become a manufacturable, safe, and efficacious drug. Developability assessment measures those characteristics of a drug candidate that make it suitable for development and manufacturing at scale – helping reduce project risk and increases the chances of advancing a molecule to regulatory approval.

Why is early developability assessment important?

Bringing a biopharmaceutical from discovery to market is challenging and costly. Without early developability assessment, many promising molecules fail due to manufacturability, safety, or efficacy issues. Assessing early helps de‑risk development, manage timelines and budgets, and improve success rates.

What core questions does Abzena focus on when assessing developability?

Abzena’s approach centers on two fundamental questions:

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

These questions guide early molecule triage and optimization.

What makes Abzena’s approach to developability unique?

Abzena blends decades of complex biologics design experience with stage‑appropriate assays to refine candidate selection criteria over time. This ensures large molecules are continually evaluated and optimized as a project progresses.

What are the main scientific areas Abzena focuses on during developability assessment?

Abzena’s developability platform solution centers on four key scientific areas:

  1. Complex Biologics Design & Optimization (mAbs, bispecifics, bioconjugates, etc.)
  2. Binding & Function (assessing mechanisms of action and potency)
  3. Immunogenicity & Safety (using tools like iTope‑AI, EpiScreen® 2.0, whole-blood cytokine release assays)
  4. Manufacturability (identifying liabilities, stability issues, aggregation risks)

How does Abzena evaluate immunogenicity and safety risks?

Abzena uses a suite of predictive and empirical tools, including:

  • iTope‑AI (in silico MHC Class II prediction)
  • EpiScreen® 2.0 (PBMC‑based immunogenicity risk assessment)
  • Whole‑blood cytokine release assays (safety profiling)

These tools help predict and mitigate potential immune responses early.

How does Abzena assess manufacturability?

Manufacturability is assessed by:

  • Evaluating sequence liabilities
  • Testing stability and aggregation
  • Performing forced degradation studies
  • Aligning molecular properties with intended route of administration and dosing

What developability packages or service tiers does Abzena offer?

Abzena provides stage‑appropriate packages, including:

  • Early Stage: Rapid multi‑parameter assessment for triaging many variants
  • Later Stage: Extensive biophysical assessment (aggregation, thermal stability, forced degradation)
  • Biological & Functional Assessment: Mode of action and functional evaluation
  • Immunogenicity & Safety Assessment: Key assays to reduce patient risk

What types of biologic modalities can Abzena support?

Abzena’s design and optimization capabilities for complex biologics span:

  • Monoclonal antibodies (mAbs)
  • Bispecific antibodies

    • Bioconjugates including Antibody-Drug Conjugates (ADCs), Antibody-Oligonucleotide Conjugates (AOCs) and Radionuclide Drug Conjugates (RDCs)

  • Other complex biologic modalities

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