Intermediates, APIs, Excipients and Polymers for drug delivery solutions
PMC 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: PMC Isochem's highly skilled teams interact closely with the pilot units and multipurpose facilities.
Reduced Time to Market: PMC Isochem's knowledge and management tools ensure an optimized timing for projects.
Continuous Cost Savings: PMC Isochem delivers substantial improvements in manufacturing and creates additional value by reducing operating costs.
Security of Supply Chain: PMC Isochem optimizes and secures sourcing of raw materials, based on total transparency with customers.
cGMP (FDA) and non cGMP
Clinical batch supply
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 Pharmacopoeia
(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