Custom synthesis (CDMO): Characteristics
How one bad inspection letter can lose a contract
What this tab covers The physical and chemical properties that set its grade, price and uses, with the commercial grades and the standards that define them.A CDMO is judged on regulatory record, technical breadth, capacity, speed and IP protection. Customers audit sites, and inspection histories (warning letters, 483s) strongly affect who wins contracts.
Properties that matter commercially
| Property | Value / specification | Why it matters | Source |
|---|---|---|---|
| Regulatory track record | USFDA, EMA, PMDA inspection outcomes | decides eligibility for commercial supply | qualitative |
| Reactor capacity | Laurus 8,200 kL (FY26) | scale for commercial products | Laurus FY26 |
| Modalities | small molecules, peptides, oligos, ADCs, biologics | breadth wins integrated contracts | qualitative |
Commercial grades
- Discovery services
- Clinical-phase CDMO
- Commercial CMO
- HPAPI and ADC
- Peptide and oligo
- Biologics