Scale-Up Capabilities
We scale conjugation to match your study needs — from microgram-level screening batches to 1–2g production sufficient for in vivo efficacy and PK/PD studies. The same antibody and linker-payload you provide at small scale is conjugated with the same consistency at every scale.
From Proof-of-Concept to In Vivo Ready
Scaling a bioconjugation process is not simply a matter of multiplying volumes. As batch sizes increase, mixing dynamics, reaction kinetics, and purification methods must adapt to maintain product quality. Our team ensures that your conjugate retains the same DAR, purity, and functional activity at every scale — from a microgram screening batch all the way to a gram-scale in vivo lot.
Scale-Up Focus Areas
Process Reproducibility
- Consistent Drug-to-Antibody Ratio (DAR) across scales
- Preservation of monomeric purity (minimizing aggregation)
- Maintenance of binding affinity and functional activity
- Detailed documentation of scale-up parameters
Purification & Recovery
- Transition from spin columns to FPLC-based purification
- Efficient removal of unreacted payload and free linker
- Optimization of yield at larger scales
- Buffer exchange into study-appropriate formulations
Seamless Transition to Stage 2 and 3
As your batch size increases, robust analytics and formulation become even more critical. A 1g in vivo lot requires rigorous QC testing and stability evaluation. We seamlessly integrate Stage 1 production with Stage 2 Characterization and Stage 3 Formulation, ensuring your material is fully validated and stable before it reaches the vivarium.
