Custom Development and Manufacturing

ISOCHEM offers cGMP and non cGMP industrial exclusive custom synthesis and provides tailor made services from development to production, including route selection, process and analytical development as well as process optimization.​


 

Flexible Solutions: ISOCHEM's highly skilled teams​ interact closely
with the pilot units and multipurpose facilities.
 ​
Reduced Time to Market: ISOCHEM's knowledge and​ management
tools ensure an optimized timing for projects.​

Continuous Cost Savings: ISOCHEM delivers substantial ​improvements
in manufacturing and creates additional value​ by reducing operating costs.​

Security of Supply Chain: ISOCHEM optimizes and secures ​sourcing of
raw materials, based on total transparency with customers.​​

  • cGMP (FDA) and non cGMP​

  • Clinical batch supply​

  • Routine production​

  • Supply chain​

  • Regulatory support​

  • Risk management​

  • Full transparency    ​

 

Case studies 

Phase I advanced intermediate: 100 Kg delivery​
Achievement: development and scale-up from lab procedure ​
- Rapid development (avoiding 2 filtrations & use of DCM)​
- Minimum R&D for secured scale-up​
- Production of 100 Kg batch 4 months after kick-off​
​- Then development and scale-up of a second generation process 

Pre-launch regulated intermediate: multiton production​
Achievement: Rapid industrial technical transfer​

- Demonstration run completed 3 months after the kick-off​
- Full size batch production 4 months after the kick-off​
- Product quality – Supply chain & QA support ​
- Yield and production improvement over the following 12 months​

Generic API: new supplier ​
Achievement: development and filing of API ​

- Process developed from scratch (2 steps)​
- Analytical development and validation in addition to Pharmacopeia 
  ​(GTI’s and residual solvents)​
- Scale-up and process validation achieved within 9 months​
- Full filing data delivered to the customer  in time ​

Tolling hydrogenation of an intermediate  ​
Achievement: rapid tech transfer and production ​

- Familiarization and scale-up preparation 1  month​
- 2 successful batches the next month​
- 10 MT campaigns routinely​
 

For more detailed technical support, please contact us

Download Custom synthesis brochure