Integrated End-to-End CMC Services
Integrated End-to-End CMC Services
Getting new molecules to the clinic is difficult and complex, with many technical hurdles to overcome.
Pathfinder™ is our end-to-end CMC service, integrating API and drug product development. Our API and product teams are co-located and bridged by our broad material science and pre-formulation capabilities.
Starting with API process design and scale-up, our early developability assessments help drive candidate selection and inform formulation routes for IND enabling and human clinical trials. Formulation development runs parallel to API process scale-up and manufacture, while GMP API moves seamlessly into GMP product manufacture to supply clinical trials.
Our joined-up teams consolidate all technical data into coherent scientific reports, leading to better decision-making. API and product manufacturing under a single QMS result in the more effective delivery of clinical material, accelerating your path to the clinic.
Capabilities
Cost-efficiency
Working with a single provider reduces the management and coordination of multiple partners, simplifying communication while minimizing shipping requirements and logistics costs.
Time Savings
Streamline and expedite project timelines with seamless technology transfer to ensure consistency during scale-up.
Scientific Continuity
Benefit from seamless knowledge transfer and retention, enabling scientific continuity with support from cross-functional expert teams.
Flexibility
Flexible solutions offer tailored approaches to meet the most complex requirements.
API Process Development & Manufacturing
- Route & process design
- Non-GMP and GMP manufacturing for non-clinical and clinical
- Flexible global supply chains
Material Science & Pre-formulation
- Salt and polymorph screening
- Crystallization process development
- API characterization
- Developability assessment
- Integrated Pre-formulation & PK/PBPK
- Pre-clinical product formulation & tox supply
Product Formulation, Analytical Development & Manufacturing
- Oral solid dose
- Solubility enhancement (spray drying, lipids, micronisation)
- Hi potent handling to OEB4
- GMP Manufacturing & packaging
Regulatory Support & Consultation
- IND dossier preparation and submission
- R&D consultation
- Dedicated project management
