Process Development works with Analytical Method Development (AMD) to determine its quality attributes. We design your processes to optimize yields and remove impurities with minimal steps and optimal recovery.
Our capabilities include:
- Conjugation reaction optimization
- Chromatographic purification steps including ion-exchange, hydrophobic interaction, metal affinity, etc.
- Column chromatography from 1ml through 20L of bed volume
- TFF step optimization
- Filter sizing studies
- Lyophilization cycle development
- Stability on process intermediates and process hold steps
- Determination of Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation
We have years of experience in characterization and supporting the selection of the best candidates for progressing to clinical studies.
Early candidates can be produced from different antibodies, types of linkers and payloads to screen for the most potent solution for your target.
Material generated is used to develop your early-stage material for analytical and formulation development.
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