Early Phase API Development

TBD Pharmatech supports early-phase API development and clinical batch manufacturing for innovative small-molecule APIs, including process adaptation, scale-up, and EU cGMP production.

This stage bridges preclinical research and clinical manufacturing, enabling reliable production of API batches for Phase I–III clinical studies under controlled GMP conditions.

We provide

• Process adaptation from laboratory to GMP manufacturing
• Scale-up for early-phase clinical batch production
• Manufacturing of clinical API batches (Phase I–III)
• Analytical method development and validation
• Quality control and GMP documentation support
• Regulatory support for clinical supply

Clinical batch capabilities

• Production of small-molecule APIs for early-phase clinical trials
• Flexible batch sizes within approximately 3–200 kg range
• EU cGMP-compliant manufacturing environment
• Integrated analytical testing and quality systems
• QP release for clinical trial supply

When to work with TBD Pharmatech

• When moving an innovative API from preclinical to clinical phase
• When transferring a process into EU GMP manufacturing
• When reliable clinical batch production is required
• When scaling up early-stage processes for human trials
• When working with niche or complex small-molecule APIs

Integration with CDMO services

Early-phase API development and clinical manufacturing are supported by integrated CDMO capabilities, including route scouting, process development, and scale-up. This ensures continuity from laboratory development through clinical and commercial API supply.