The two Italian companies will offer their clients a high-tech, integrated full-service to handle challenging projects requiring various skills and technologies, by merging their expertise in research, chemical development, set up of polymorphs, tech transfer, scale-up and GMP manufacturing. Each company will contribute to the synergy through hi-tech services, expertise and know-how.
PolyCrystalLine will be in charge of solid-state studies and related specific chemistry while ICROM will handle GMP scale-up and manufacturing of chemical and crystallization processes.
Merging high level professionals from the two teams will ensure time efficiency, cost control and high performance leading to an overall improvement for the benefit of all clients.
THE TWO COMPANIES
PolyCrystalLine was founded in 2005 as a start-up within the crystal-engineering group of the University of Bologna.
It has since grown into a company specialized in providing reliable solutions to optimize and control the crystallization process of Active Pharmaceutical Ingredients for pharmaceutical companies. This mission is accomplished by the engagement of over 25 highly skilled employees.
“It is a pleasure, as CEO of PolyCrystalLine, to announce this strategic alliance with ICROM, a company that will extend our services portfolio guaranteeing the cGMP manufacturing of API with consistent solid-state properties” states the CEO of PolyCrystalLine, Stefano Luca Giaffreda.
Icrom has over 50 years of experience as a chemical-pharmaceutical Company focusing on the development and multi-scale GMP manufacturing of Active Ingredients.
With up to 90 m3 reaction capacity and 85 employees among R&D, Operations, Quality&Regulatory, Finance and Marketing, the Company delivers its products and services to more than 40 Countries worldwide and supports the global Pharmaceutical segment both as CDMO for new chemical entities and delivering high quality APIs to the generic Drug market.
“We are proud to announce the creation of a strategic hub, where ICROM and PolyCrystalLine will join their expertise, technologies, and resources. We will maximize each other's skills while providing the Pharmaceutical segment with solutions for chemical development and custom manufacturing of APIs" says the CEO of Icrom, Pierfrancesco Morosini.
The two companies will jointly provide research and development capabilities, creating a unique team of +20 scientist to share skills, equipments, expertise, and know-how.
Lab spaces and cutting-edge tools will also be “connected”, making controlled reactors for site monitoring and crystallization process available and more accessible.
The use of the most recent Advanced process analytical tools (PAT) on controlled reactors equipped with in-situ sensors, such as Crystal 16 or Mettler Toledo EasyMax working station, will allow R&D activities to be available from 4ml on crystal 16, to 10+ Liter Reactors; enabling a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect critical quality attributes (CQA).
With the high cointainement system on point, thanks to stainless steel isolators, the R&D activities can be easility performed on highly potent API, up to OEB 5 (5L controlled reactor).
Each project will be supported by both the analytical teams equipped with state of the art technology such as:
- Xray Diffractometer, DVS intrinsic, Malvern Morphologi G3, and Mastersizer 3000.
- Chromatography tools such as GC, GC-HS, HPLC-Ms, UPLC-Ms
The processes set-up at lab scale is then easily transferred through a joint tech-transfer Team to the GMP workshops at ICROM, where the process can be up-scaled for pilot and validation manufacturing from few Kgs up to tons.
The reactions are constantly followed thanks to automated setting systems in equipment with multi-scale capacities from 25L glass reactors, to stainless-steel, glass-lined and Hastelloy reactors from 500 L to 6’000L and including a dedicated GMP unit for HP-API manufacturing.
The solid state consistency of industrial batches will be ensured by the Team, screening polymorphs, salt or co-crystals. The solid state analyses cGMPfor batch release whereas requested are available in house, including X-ray diffraction, Particle size distribution and Surface Area (BET).
Because of this alliance, ICROM and PolyCrystalLine's services value will boost consistently, providing a strategic hub able to deliver a comprehensive service offer to the pharmaceutical market.