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Manufacturability Assessments

Why Manufacturability ASSESSMENTS for mAbs?

Antibody candidates can show good efficacy, pharmacokinetics, and pharmacodynamics but still present poor CMC properties, such as propensity to aggregate, susceptibility to degradation, subpar stability, and undesirable post-translational modifications. What if we could predict which molecules are less likely to behave that way? If so, wouldn’t you want to know sooner rather than later?

Introducing Manufacturability ASSESSMENTS

We believe mAb candidate selection to be a three-pronged approach that goes beyond safety and efficacy and looks at manufacturability as a key component of that decision-making process. Our manufacturability screening capabilities allow us to assess up to six of your candidate molecules and help you select your lead mAb candidates based on their predicted suitability for manufacture prior to beginning any cell line development work. Read more about Cell Line Development.

Make Better, Informed Decisions

  • Evaluate structure and stability of your candidate molecules and understand their molecular personality before selecting a lead mAb candidate
  • Get early read-outs on how well a candidate is likely to perform in development and manufacturing
  • Ensure the best candidate is selected based on:
    • bioinformatics analysis
    • expression levels in host cell line (transfectant pools)
    • stability within purification operations
    • pre-formulation and biophysical screening

Smoother Path to IND

Performing manufacturability assessments during selection:

  • Improves predictability of candidate behavior during process development and manufacturing, reducing need for rework due to unexpected events
  • Reduces the need for titer and yield optimization during early development
  • Allows you to identify candidates that are likely to be the most stable, easy to formulate, and to have a longer shelf life

Maximize Production Efficiency

Candidates with a high manufacturability score are more likely to:

  • Need smaller-scale manufacturing
  • Need smaller campaigns
  • Have lower cost of goods

Optional Material Supply Run with Lead Candidate

  • See how your selected candidate behaves in platform process at 10 L scale
  • Ensures material availability for preclinical work, enabling timely development start
  • Typically generates 10-15 g of product

 

Contact us to learn how we can de-risk your lead candidate selection