By utilizing our deep knowledge of chemistry and bioconjugation we rapidly develop and streamline your program development and commercial timelines.
Our Development Capabilities
Our process development approach is defined and designed to ensure scale up directly from bench scale to final manufacturing.
Our experience goes beyond ADCs, including bioconjugates, oligonucleotides, nanoparticles, and vaccines.
Development capabilities include:
Our Design Capabilities
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:
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.
Stability
Stability indicating assays are identified early on via forced degradation studies performed during process development.
Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.
Using a diverse range of expertise in developing and manufacturing ADCs, bioconjugates and linker payloads, we create tailored solutions for your program.
We adapt our approach to shorten lead times and develop risk mitigations strategies to ensure your overall success in delivering vital medicines to patients safely.
