Community Research and Development Information Service - CORDIS

FP7

CRYSTAL-VIS — Result In Brief

Project ID: 605814
Funded under: FP7-SME
Country: Ireland
Domain: Health, Industry

Better control of crystal properties for industry

Researchers have developed imaging technology to monitor and control crystal formation in real time during manufacturing processes.
Better control of crystal properties for industry
An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is responsible for pharmacological activity. Crystallisation is a critical step during API manufacture, with around 70 % of APIs going through a crystallisation step at some point in their manufacture.

Controlling the final shape and size of these crystals is a major challenge to manufacturers, particularly as it is often difficult to monitor and measure. API molecules are becoming increasingly complex, tending to reduce aqueous solubility and often leading to difficulties in crystallisation. Understanding the crystallisation process is fundamentally important for reducing failure during drug development.

The EU-funded CRYSTAL-VIS (A process analytical technology for characterising the physical properties of crystals) initiative brought together industrial SMEs to develop a revolutionary imaging-based physical characterisation device. The researchers developed a prototype device that uses imaging-based physical characterisation technology for real-time control of crystallisation during the manufacturing process.

CRYSTAL-VIS designed a prototype, developed software and algorithms, created a user interface, and integrated and validated the technology within a crystallisation vessel in an industrial setting. The researchers used three different approaches to probe market requirements: visits to pharmaceutical companies, an online survey and participation in a conference.

Researchers carried out an online survey using Google Forms, to determine current technologies in use in the industry. In the questionnaire, they aimed to determine industry’s needs for the Crystal-Vis technology as well as operating ranges and platforms for it.

Researchers received positive responses to the Crystal-Vis technology, indicating definite need within the industry for such a device. The survey identified particle size distribution as the most important characteristic to focus on, followed closely by crystal shape.

While respondents identified crystals in the size range 0-50 µm as the most important, 12 % of respondents identified crystals greater than 150 µm to also be important. These findings revealed a definite need among API manufacturers to gain a greater understanding of their crystallisation processes.

Related information

Keywords

Imaging technology, crystal formation, active pharmaceutical ingredient, crystallisation, CRYSTAL-VIS
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