services

CDMO

CDMO

The integration of our CRO knowledge and CDMO capabilities places PolyCrystalLine as an excellent partner in the production of intermediates and APIs in GMP compliance.

Our team can support you in the optimization and in the synthesis of challenging molecules from gram to kilogram scale with consistency and optimized physical and bulk properties.

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

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.

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.

LET’STALK

Contact US for more info.