Purer Solutions For A Better Life
8 Anzhi Street
Suzhou Industrial Park
Suzhou, Jiangsu, 215024, China
World-class process Research and Development are crucial in developing robust and dependable drug development and commercial processes at Agno Pharma. We support process design, route scouting, safety evaluation, process optimization, and continuous process improvement, striving for safer, more robust, cost-effective, and environmentally friendly processes. Our advancements in flow chemistry and biotransformation exemplify these efforts and cater to projects at various stages of development. Our team of 70 process-development chemists in Suzhou excels in creating commercial processes tailored for Agno Pharma’s wholly owned cGMP manufacturing facility in Lianyungang, Jiangsu Province. Typically, our Suzhou R&D staff travel to our production facility to ensure seamless chemistry transfer.
Our expertise can expedite your project from laboratory experimentation to clinical trials while maximizing value through a phase-appropriate approach. Agno Pharma’s comprehensive process development strategy aims to mitigate risks by ensuring safety and reproducibility from laboratory experiments to full-scale production. Leveraging our extensive experience, we naturally recommend starting materials, intermediate specifications, impurity profiling and isolation, proven acceptable range (PAR) parameters, and identification of critical process parameters (CPP). Advanced analytical methods underpin all our process activities, validating every decision.
Agno Pharma’s R&D facility boasts 72 research hoods and 28 walk-in hoods. Our kilo lab is equipped with up to 100-L reactors, a thin-film evaporator, fractional distillation equipment, centrifuges, Buchi rotary evaporators, flow reactors for hydrogenation, and medium-pressure chromatography systems. This infrastructure enables us to swiftly scale up laboratory processes to produce starting materials, registered starting materials, intermediates, and APIs at kilogram scales.
Our analytical group employs advanced instrumentation such as LC-MS, HPLC, GC, DSC, KF, RSD, and UV for product development, impurity identification, in-process control, and product testing and release. Instruments like DSC and ARSST are utilized in our safety evaluation lab for process safety testing. We prioritize environmental sustainability and employee safety with advanced features such as fresh air-conditioned makeup air, an explosion-proof Class-A solvent warehouse, and centralized waste liquid management systems.
Our purchasing team is well-versed in China’s chemicals market and maintains relationships with numerous producers worldwide.
As of June 2024, Agno Pharma has published three papers in Organic Process Research & Development on enzymatic chemistry (OPRD 2011, 291-293), process safety studies (OPRD 2012, 2021-2024), and process development (OPRD 2024, 2659-2666).
We have filed 62 patent applications, with 41 granted. Additionally, our clients have filed two patents (WO 2016/064900 A1 and WO 2021/243171 A1) based on the innovative processes developed by Agno Pharma.