The collaboration will see Glatt Systems – an India-based subsidiary of Germany’s Glatt – incorporate PAT tools into its own fluid bed and continuous process equipment, offering drugmakers more options to capture critical real-time data during all stages of a product life cycle.
“By integrating with Glatt's systems, pharmaceutical processes can be monitored continually throughout the process in real time and so allows any deviations to be picked up and thereby corrected in real time,” Ian Jones, CEO of Ireland-based Innopharma told in-Pharmatechnologist.com.
“This gives the manufacturer the opportunity to reduce batch failure and increase product quality,” he continued, adding such tools would also aid the Quality by Design (QbD) approach to product development being adopted by an increasing number of companies.
Among the offerings being integrated is Innopharma’s Eyecon technology, a particle analyser which is used for the analysis and profiling of powders and bulk solids.
“Eyecon is a non-product contact, direct imaging system that generates real-time on screen images, showing particle size and shape information,” Jones explained.
“Eyecon enables better process understanding, faster development, more robust & reliable processes with fewer out of speck batches and investigations,” he told us, adding that such improved control of the process can enable increased productivity and reduce cycle time and cost.
The collaboration is specifically targeting the Indian market where Glatt has a significant presence and a significant client base using its fluid bed systems.
“India is a world player in terms of pharma manufacturing - worth US$6B in 2015 and expected to reach $55B by 2020,” Jones said. “Outside the US it has the largest number of US FDA approved facilities and is the sixth largest market globally in absolute size.”
The country has also been subject to a regulatory clampdown over the past few years, which has led to a large number of US FDA warnings and consent decrees being issued to both API and finished formulation manufacturers.