CatSci Ltd. Cardiff, United Kingdom of Great Britain and Northern Ireland (the)

About CatSci Ltd. :

CatSci Ltd are an award-winning innovation partner for medicines development who are committed to creating tailored solutions from candidate selection through product launch and beyond. We break down the silos in small molecules, TACS, glues and oligonucleotides CMC development to accelerate the delivery of life-changing medicines to patients in need.

Service Offerings:

• Process Chemistry & Chemical Development
• Route scouting and selection
• Rapid route development and scale-up
• Process design & development & optimization
• Thermal hazard identification and mitigation
• Kilo-scale non-GMP and GMP material supply
• Technology transfer for late-stage and commercial manufacture
• Analytical Science Method development and validation (aligned with ICH Q14 and USP <1220>)
• Impurity identification and characterization
• Forced degradation studies
• Trace element analysis (aligned with ICH Q3D)
• Stability studies
• Drug substance and product batch release testing
• Oligonucleotide sequencing and analysis
• Oligonucleotide Research & Development & Manufacturing
• Synthesis from nanomole quantities up to 30 grams
• Process robustness studies for late-phase development
• Analytical characterization using high-resolution HPLC-MS
• Expertise in CMC and regulatory requirements for oligonucleotide therapeutics Crystallization Solid State & Preformulation Salt and polymorph screening
• Crystallization design and optimization
• Pre-formulation studies including formulation definition for pre-clinical studies
• Particle and formulation risk assessment
• Comprehensive physical property measurements
• Development and optimization of catalytic processes
• Advanced data science and visualization techniques
• High Potency API (HPAPI) Development Safe handling and development of high potency compounds (OEB-5)
• Process invention and characterization
• Crystallization
• Isolation and drying
• Analytical method development and sample analysis

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