A streamlined project control and management between PolyCrystalline SPA sites will guarantee besides an efficient technology transfer, an unbeatable support with all the analytical techniques available in our facilities.
services
CDMO
CDMO
cGMP Manufacturing (Pre-Clinical, Phase I, II and III)
Our new small molecule API custom manufacturing capabilities integrated with our R&D facility will allow PolyCrystalLine CDMO to bring your project from early phase development to scale-up and commercial manufacture with our focus on the right solid forms. We have been doing this for many years. PolyCrystalLine CDMO is a partner that you can trust.
Quality by Design (QbD) Process Development
PolyCrystalLine CDMO’s Scientists have a unique experience in design, develop and optimize robust, reliable and cost effective processes.
Integrated Technology Transfer and Full Analytical Support
Scale-Up and Tech Transfer
We offer efficient scale up of multi-step procedures. The use of automated reactors (with FT-IR, FBRM, pH, temperature and turbidity sensors, etc.) guarantees the monitoring of all parameters.
- Real-time crystallisation monitoring to generate detailed profiles.
Custom Synthesis
We can synthesize and characterize reference compounds of APIs, pharmaceutical intermediates and critical process related impurities in a timely and cost-effective manner. Also, we can support you with the development of a control system for impurities involving manufacturing conditions and suitable analytical methods.
- Scout the best API supplier on the market.
- Reproduce the selected procedure to obtain the desired crystalline form.
- Deliver the selected crystalline form with high purity profile and CoA.