About 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.

A fully integrated CDMO

GMP compliant

Multi – Kg scale reactors

High containement systems for OEB5

Why Choose us?

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EFFICIENCY

Working closely with our clients allows us to tailor each project optimizing time and leading to successful results.

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RELIABILITY

We are committed to continual improvement based on sound science and the use of modern technologies providing clear and trustful result.

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EXPERTISE

Highly trained team of chemists and analysts with more than 15 years of experience in the discovery of new solid forms and in the development and optimization of crystallization processes.

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INTEGRATED

From the discovery to the development of new APIs under the same roof with a quick and reliable technology transfer.

API Custom Manufacturing

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. The investment in the process development and optimization can derisk the API’s Pathway to the clinic, avoiding batch failure and tuning expensive and inefficient production operations.

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. For more than 15 years we have been extensivly characterizing more than 500 different APIs, investing in new state of the art equiments. We won’t stop now.

POLYCRYSTALLINE ROADMAP ROADMAP

2005

Foundation of PolyCrystalLine SpA

2006

From Start-up to Company

2007

Purchasing of First XRay Diffractometer

2009

Moved to custom made facility in Medicina (Bo)

2014

First AIFA inspection

2015

GMP certification

2016

Construction of 2nd facility in Medicina (Bo)

2017

FDA inspection

2018

Beginning of PolyCrystalLine CDMO project

2019

Expansion of Laboratory in Medicina

2020

Covid

2022

Launch of PolyCrystalLine CDMO

POLYCRYSTALLINE CDMO NEWS NEWS

  • 1 Ottobre 2021
  • NEWS
PolyCrystalLine attending CPhI 2021 in Milan!

Meet us at the forthcoming CPhI 2021 in Milan, from November 9 to November 11. ...

  • 7 Giugno 2021
  • NEWS
PolyCrystalLine CDMO is on the way

The construction work of the new facility started in Mesagne (BR), Puglia in June 2021.

  • 10 Gennaio 2021
  • NEWS
Render of PolyCrystalLine CDMO

This is the  render of PolycrystalLine’s new facility, dedicated to the new CDMO services, that...

Contact

Get In Touch

Any question? Reach out to us and we’ll get back to you shortly.

  • phone(+39) 051 6970791
  • mailinfo@pcl-cdmo.com