PolyCrystalLine

Our mission is to support our clients during drug development, helping them to reduce batch failure, avoiding costly crystallisation issues and overall offering greater confidence in drug quality during manufacturing. We can support you from early-phase drug discovery to kilogram supply.

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

About Us

PolyCrystalLine CDMO

In 2018 PolyCrystalLine decided to launch PolyCrystalLine CDMO. A new Contract Development and Manufacturing Organization (CDMO) cGMP certified to complete the R&D Service provided by Polycrystalline SPA. This new division will enable Polycrystalline Group to unlock integrated solutions starting from the R&D activities to the production of GMP certified Batches. With this new site Polycrystalline intends to confirm and improve the capacity to help pharma companies, connecting our legacy of experience in solid state chemistry with their requirements for innovation, commercial manufacturing and product success. Starting from Q3 of 2022, PolyCrystalLine CDMO will offer a comprehensive portfolio of solutions to fully control and understand your process, thus enabling consistent, robust production of cGMP quality products.

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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 will be 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 the all 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.

Why we are different?

 

We are a high performing cohesive team of trained chemists and analysts, with more than 10 years of experience in the development and optimization of APIs crystallization.

We care about results and innovation based on sound science and the use of modern technologies.

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