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.
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 enables Polycrystalline Group to unlock integrated solutions starting from the R&D activities to the production of GMP certified Batches. With the new site Polycrystalline intends to confirm and improve the capacity to support pharma companies, connecting our legacy of experience in solid state chemistry with their requirements for innovation, commercial manufacturing and product success. Starting from Q2 of 2023, 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.
services
CDMO
CDMO
OUR COMMITMENT
As Polycrystalline CDMO we see ourselves as your strategic partners, with our reliability and our full commitment to meet your need into the development of new APIs and HPAPIs we want to unlock the full potential of our partnership going beyond the classic client/supplier relationship.
Our recent investment is aimed to meet and outmach your expectations, our innovative technologies, our custom made plant , our highly skilled scientisst and our continuous reaserch to reach the excellence are just some of the keys of Polycrystalline CDMO.
We look forward to have the chance to be your partner and join Polycrystalline in the journey from a small start-up to a fully integrated 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 ensuring 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
When it comes to the production of your API you want to be sure to have the right process in your hands. That’s why Quality by Design approach for the process delopment is one of our main focus! Our approach ensures the robustness of the process, employing statistical, analytical and risk-management methodology in their design, development and manufacturing. With Polycrystalline you will get the quality you need.
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 using the most recent process analyzing tools allows us generate detailed crystallizion profile necessary to optimize each process.
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.
