Developability Assessment: the Derisker

The more you understand about your molecule earlier, the better. We help you start smart and finish fast with our developability assessment solution 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.

We recognize that drug development is risky. Success is not guaranteed, and rate of failures are 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 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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