Strategic Approach to Non-GMP Manufacturing
We understand that early-stage pharmaceutical development demands a unique balance of speed, flexibility, and quality. Our non-GMP capabilities are specifically designed to accelerate your development timeline while strategically incorporating key quality elements that facilitate a smooth transition to GMP manufacturing.
Accelerated Development Services
- Rapid Synthesis Solutions: Fast-tracked synthesis routes for medicinal chemistry programs and lead optimization
- Flexible Scale-Up: Quick transition from milligram to multi-kilogram scale for preclinical and early clinical needs
- Process Optimization: Efficient parameter screening without the documentation burden of full GMP
- Analytical Support: Method development and preliminary validation to support early characterization
- Material Supply: Expedited delivery of non-GMP intermediates and APIs for toxicology studies and formulation development
Quality Elements Without GMP Constraints
Our non-GMP operations strategically incorporate quality principles that support your product’s eventual GMP transition:
- Documentation Framework: Right-sized batch records and analytical reports capturing critical process information
- Material Control: Proper identification and inventory management
- Equipment Qualification: Basic functionality validation
- Process Reproducibility: Focus on consistency and quality with streamlined verification
- Analytical Testing: Reliable characterization employing many of the same instruments used in our GMP facilities
Risk-Based Quality Implementation
We employ a thoughtful, phase-appropriate approach to quality:
- Critical Parameter Identification: Early focus on process parameters that impact product quality
- Impurity Profiling: Identification and control of significant impurities prior to GMP manufacturing
- Stage-Appropriate Controls: Gradual implementation of controls based on development phase and program needs
- Quality Risk Assessments: Simplified risk management to prioritize critical quality attributes
- GMP Readiness Planning: Strategic roadmap for transitioning processes to full GMP compliance
Facilities Designed for Speed and Flexibility
- Dedicated Non-GMP Laboratories: Purpose-built spaces for rapid experimentation and development
- Kilo Lab Capabilities: Scale-up equipment mirroring GMP facilities for process consistency
- Analytical Instrumentation: Advanced equipment matching GMP capabilities for reliable data correlation
- Sample Management: Organised storage systems for retention and future reference
- Data Management: Secure storage and preservation of all data for easy retrieval
- Collaborative Workspace: Open environment facilitating scientist-to-scientist communication and problem-solving
By understanding exactly when and how to apply quality controls, we deliver the speed your early-stage programs demand while intelligently incorporating quality elements that ensure a smooth transition to GMP manufacturing. Leverage our technical expertise to gain a competitive edge in your market today!