Phase I clinical development
Transitioning to First-in-Human
We bridge the gap between discovery and first-in-human, ensuring your process, material, and data are ready for GMP execution.
- Overview
- How we support you
- Our core capabilities
- Our therapeutic modalities
- What this stage enables for your programme
- Why it's different working with us
- In our own words
Transitioning from discovery to first-in-human requires the integration of chemistry, engineering, analytical, and solid-state expertise into a manufacturable reality.
Many programs stall at this point. Routes that worked in the lab fail at scale, impurities emerge unexpectedly, or material supply cannot meet GMP standards.
We help you cross that boundary. We develop safe, efficient, and sustainable processes, ensuring your compound is ready for GMP manufacture, analytical qualification, and regulatory submission. We bridge the gap between discovery and clinical readiness, helping you choose the right GMP partner and building the scientific and technical foundation to support every subsequent phase.
Our Core, Phase I Capabilities
• Rapid route development, optimisation, and scale-up studies
• Thermal hazard identification and mitigation for safe operations
• Model-led process definition and design-space exploration
• Green chemistry integration for sustainability and cost efficiency
• Method development, optimisation, and qualification aligned with ICH Q14
• Impurity profiling, characterisation, and trace-level analysis
• Forced degradation, stability, and validation studies
• Large-scale purification and advanced separation techniques (SFC, chiral, EPSA)
• Experimental and in-silico evaluation of absorption, distribution, metabolism, and excretion
• Identification of metabolic pathways and potential liabilities
• Bioanalysis method development and validation
• PK data interpretation to support dose selection and toxicology bridging
• Salt and polymorph screening, crystallisation design, and control strategy
• Pre-formulation and developability assessment for FTIH compatibility
• Particle engineering, filtration, and washing optimisation
• In-situ particle measurement and imaging for PAT-driven process control
• SafeBridge®-certified containment and handling facilities
• Route design, process invention, and characterisation
• Crystallisation, isolation, and drying of HPAPI intermediates and products
• Analytical method development and in-process monitoring for safety assurance
• Homogeneous, heterogeneous, and biocatalytic reaction screening and optimisation
• Asymmetric hydrogenation and high-pressure catalytic processes
• Data-rich experimental design and visualisation using advanced informatics
• Route efficiency improvement for yield, selectivity, and sustainability
What This Stage Enables for Your Programme
By partnering with us, you move into Phase I knowing your process is ready, your analytical data is defendable, and your material supply is secure.
Our integrated approach removes the uncertainty from early manufacturing, providing the technical depth, documentation, and confidence required to enter clinical manufacture smoothly and safely.
Why It’s Different Working With Us
