At Presude Lifesciences, we provide advanced process research services to expedite the scale-up of lead compounds and intermediates, bridging the gap between research and commercialization. Whether it is an expansion of an existing scalable process or de novo development for new IP, our professional staff can assist in optimization of these routes. We assist our clients in transferring their laboratory projects to pilot-scale production with real-time reaction profiles and total process development. Our cutting-edge Process Chemistry and Scale-Up facility is equipped to tackle the complex challenges of chemical R&D and kilo-scale production, ensuring a smooth transition from discovery to large-scale synthesis of lead compounds, route scouting, process development, and validation. Our key services include the following:
Our team has extensive experience in designing novel and commercially viable synthetic routes. We perform the selection and screening of routes efficiently, focusing on the availability of raw materials, safety, economics, and robustness.
Our team of experienced scientists excels in developing robust, efficient, and scalable processes that deliver high yields and minimize waste. By employing systematic methodologies and identifying critical process parameters, we offer:
- Development and optimization of synthetic routes for APIs, lead compounds, and key intermediates.
- Scale-up of processes from lab to pilot to commercial scale.
- Process validation to ensure consistent quality and compliance.
- Troubleshooting and optimization of existing processes.
We facilitate seamless technology transfer by preparing comprehensive technology transfer packages that include:
- Detailed Process Descriptions: Detailed descriptions of manufacturing processes and analytical methods.
- Standard Operating Procedures (SOPs): Well-documented SOPs to ensure consistent execution of processes.
- Validation Reports: Thorough validation reports to support commercial scale synthesis.
- Training and Support: Providing training and ongoing support to ensure successful implementation at the receiving site.
Partner with us to ensure expedited process development and large-scale synthesis of your products. Write us to learn more