Biologics Manufacturability Assessment
Put Your Best mAb Forward
Monoclonal antibody (mAb) candidate selection should go beyond safety and efficacy and include manufacturability as a key component of that decision-making process. With our manufacturability screening capabilities, we can assess your candidate molecules and help you select your lead mAb candidate based on its predicted suitability for manufacture prior to beginning any cell line development work.
Helping You De-Risk Lead Candidate Selection
- 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
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 have a longer shelf life
How Our Manufacturability Assessments Work
We rank your candidates based on risk and make observations at each stage of the manufacturability assessment. At the end of the screening, we collate the ranked data and make a comprehensive recommendation based on each candidate’s overall suitability for manufacture.
To ensure material availability for preclinical work and enable a timely development start, we offer an optional material supply run with your lead candidate, confirming the selected candidate performs well in the platform process at 10 L scale.
