# Custom synthesis (CDMO): Characteristics

How one bad inspection letter can lose a contract

Source page: https://www.materialinsights.org/chemicals/custom_synthesis/characteristics/

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

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/custom_synthesis/index.md)
- [Overview](https://www.materialinsights.org/chemicals/custom_synthesis/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/custom_synthesis/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/custom_synthesis/routes/index.md)
- [Production](https://www.materialinsights.org/chemicals/custom_synthesis/production/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/custom_synthesis/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/custom_synthesis/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/custom_synthesis/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/custom_synthesis/movement/index.md)
- [Regulation](https://www.materialinsights.org/chemicals/custom_synthesis/regulation/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/custom_synthesis/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/custom_synthesis/links/index.md)