Process Development & Scale-Up
Reproduce your optimized conjugate at 1–2 g scale with the same DAR, purity, and activity you saw at the bench. You provide the antibody and linker-payload; we handle the scale-up chemistry, purification, and QC.
Our Scale-Up Process
We follow a structured process development workflow to ensure that every scale-up is a faithful reproduction of your discovery-stage conjugate — using the same antibody and linker-payload you provided at small scale, not a new experiment.
Process Review & Transfer
We review your existing conjugation protocol (or our own if we made your Stage 1 material) and identify any parameters that need optimization for larger scale — reaction volume, mixing, temperature control, and reagent stoichiometry.
Conjugation Route Optimization
We fine-tune the conjugation conditions at intermediate scale to maximize yield and DAR consistency before committing to the full-scale run. Reaction parameters are locked before scale-up.
Purification at Scale
We use FPLC (Fast Protein Liquid Chromatography) and ultracentrifugation to remove unconjugated antibody, free drug, and aggregates from your scaled-up conjugate. Purification conditions are optimized to maximize yield without compromising purity.
Full QC Release Testing
Every lot is tested against the same analytical panel used for your Stage 1 material — DAR by HIC and LC-MS, purity by SEC, and functional activity — to confirm lot-to-lot consistency.
Delivery & Documentation
You receive your conjugate in your specified formulation buffer, along with a complete Certificate of Analysis (CoA) and process documentation suitable for regulatory submissions and IND preparation.
Scale Options
What We Produce
- Microgram batches for screening
- Milligram lots for in vitro validation
- 1 g lots for in vivo efficacy studies
- 2 g lots for repeat-dose in vivo studies
- Custom scale on request
What’s Included in Every Lot
- DAR determination (HIC + LC-MS)
- Purity by SEC-HPLC
- Endotoxin testing
- Protein concentration (A280)
- Certificate of Analysis (CoA)
- Process development report
