TBD Pharmatech supports technology transfer of small-molecule APIs into EU cGMP manufacturing, including process adaptation, scale-up, and preparation for clinical or commercial production.
We enable the transition of API processes from laboratory development or external suppliers into controlled GMP manufacturing environments.
We provide
- Transfer of API processes into EU cGMP manufacturing facilities
- Process adaptation for GMP execution and scale-up
- Technical evaluation and optimisation of transferred processes
- Integration with analytical, quality, and regulatory systems
- Preparation for clinical and commercial API manufacturing
Technology transfer scope
- Transfer from laboratory-scale or pilot processes
- Transfer from external CDMOs or manufacturing partners
- Adaptation to EU cGMP production requirements
- Alignment with facility capabilities and batch scale (3–200 kg)
When to work with TBD Pharmatech
- When transferring API processes into EU GMP manufacturing
- When moving from development to clinical or commercial production
- When replacing or supplementing an existing manufacturing partner
- When scaling up processes for reliable GMP execution
- When working with niche or complex small-molecule APIs
Integration with CDMO and manufacturing services
Technology transfer is supported by integrated CDMO capabilities, including process development, scale-up, and GMP manufacturing. This ensures continuity from development through clinical and commercial API supply.
