Our GMP synthesis plant II and R&D center have successfully completed over a year of continuous operations serving the global pharmaceutical and biotechnology sectors. Throughout this timeframe, we have substantially expanded our technical and operational throughput for small and medium-scale batch production. This infrastructure provides optimal equipment sizing for active pharmaceutical ingredient (API) manufacturing geared toward preclinical development and clinical trial phases.
Backed by state-of-the-art facilities and a rigorous quality control framework, KINSY delivers flexible, strictly regulated chemical solutions aligned with international pharmacopeia standards and cGMP guidelines.
Chemical development and scale-up capabilities
Our research facilities are fully equipped to guide target compounds across every phase of analytical development, route scouting, and process optimization:
R&D Laboratory: Operating capacity ranging from 5 mL to 10 L, outfitted with automated reactors and modern flash chromatography systems (Biotage 75 and Biotage 150).
Scale-up Area: Flexible working volumes between 6 L and 100 L, dedicated to process validation, safety screening, reaction profiling, and intermediate batch preparation prior to full commercial scale.
GMP synthesis plant production capacity
To guarantee full compliance with rigorous international regulatory frameworks, our manufacturing environment houses specialized production suites and cleanrooms:
GMP Laboratory: Focused on high-purity small batches of APIs and critical intermediates (15 g to 300 g).
GMP Production Plant: Versatile reaction vessels ranging from 10 L to 400 L, fully engineered for cryogenic reaction conditions (-80 °C) and precise temperature control.
Advanced Purification: Industrial-scale flash chromatography (Biotage 400), ensuring strict control over impurity profiles, compound isolation, and regulatory specifications.
CDMO partnership and custom synthesis
Direct collaboration between our research scientists, analytical specialists, and plant chemical engineers streamlines technology transfer, mitigating project risks and accelerating delivery timelines under CDMO contracts. We support our partners through all project milestones, ensuring robust analytical documentation, process validation protocols, and comprehensive batch release records.
To assess technical feasibility or discuss your project specifications with our chemical engineering team, reach out through our contact page.
