Stage 3 — Formulate & Scale
ADC Formulation Services
Identify the right buffer, confirm stability across storage conditions, and ensure your ADC survives the journey from bench to animal study — or beyond.
What We Offer
Formulation development is often an afterthought — until your ADC aggregates in the syringe or loses activity after a freeze-thaw cycle. We help you get ahead of these problems early.
Buffer Screening
- pH range screening (5.0–8.0)
- Excipient panel (sucrose, trehalose, mannitol, polysorbate 20/80)
- Salt concentration optimization
- Accelerated stability (40°C, 1–4 weeks)
- Readouts: SEC, DAR, activity
Freeze-Thaw Stability
- Up to 5 freeze-thaw cycles tested
- Multiple time points (T=0, 1wk, 1mo, 3mo)
- Analytical panel at each time point
- Comparison across formulation conditions
- Storage condition recommendations
Formulation Recommendation Report
- Ranked formulation candidates
- Supporting analytical data
- Recommended storage conditions
- Risk assessment for in vivo use
- Ready for regulatory documentation
Stability Study Time Points
We design stability studies to match your program timeline and regulatory needs.
| Time Point | Storage Condition | Analyses Performed |
|---|---|---|
| T = 0 (Baseline) | Fresh / post-formulation | SEC, DAR (HIC/LC-MS), activity assay |
| T = 1 week | 4°C, −20°C, −80°C | SEC, visual inspection |
| T = 1 month | 4°C, −20°C, −80°C | SEC, DAR, activity assay |
| T = 3 months | 4°C, −80°C | Full panel: SEC, DAR, LC-MS, activity |
| Freeze-Thaw Cycles | −80°C ↔ RT (up to 5 cycles) | SEC, DAR, activity at each cycle |
Need Scale-Up After Formulation?
Once you’ve identified your optimal formulation, we can reproduce your conjugate at 1–2 g scale in that exact buffer — with full QC to confirm lot-to-lot consistency.
