There is a long road to achieving regulatory approval when developing new drugs to ensure they are safe for patient use. Regulatory approval requires analyzing particle shape and size to develop stable and effective products and looking for contaminants that can come from the environment, packaging materials, formulation ingredients, interactions between the formulation and the product packaging, or generated during processing. Such rigorous analysis requires the generation and analysis of a significant amount of imaging data.
Indian company ImageProVision has been developing microscopic image analysis applications for the pharmaceutical industry for a decade. They were looking to add automation to their image capturing process and worked with Prior Scientific to add a motorized stage to their system.
Benefits of automation to achieve better regulatory compliance
ImageProVision has developed several image analytics products for pharmaceutical companies to help companies develop drugs and get them approved by the authorities.
We interviewed Sandeep Kulkarni, founder and CEO of ImageProVision, on why adding automation was necessary for their products. “The pharma industry is adopting automation where ever possible. This is required for improving productivity, avoiding manual mistakes/subjectivity, and better regulatory compliance.” tells Kulkarni, “We automated the analytics part through our software but taking images from the microscope was still manual. Though there are motorized stage microscopes in the market, the combination of automation in image capturing and analytics in a strict regulatory environment was not available.”
ImageProVision approached Prior to integrating automation and motorized stage H101A for their system to offer a value-added solution for the pharma industry. “We have then launched two products; ipvAutoCount and ipvAutoClass having Prior Scientific’s motorized stage as part of our system offering,” tells Sandeep Kulkarni and continues, “We could introduce automatic versions of products for the pharmaceutical market. Having Prior as a hardware partner, who has expertise in automation, gives us the confidence to go to the customers without any apprehensions. Our customers are also happy with the performance of our systems.”
Adding a motorized stage to the products enables the system to cover the entire area of the sample and stitches the image tiles to create a single image. The software then automatically counts the particulate matter and produces the results.
“Having Prior as a hardware partner, who has expertise in automation, gives us the confidence to go to the customers without any apprehensions.”
Prior Scientific’s motorized H101A ProScan™ stage is adaptable to virtually any microscope or optical system. The H101A stage lets the user increase labour efficiency by automatically scanning specimens and storing points for later recollection and inspection with unmatched repeatability. The challenge for ImageProVision was that there wasn’t a sample holder for the filter papers used in their particle analysis. Having the sample secured is paramount during scanning the samples to have the high-quality image tiles that are stitched together to create a single image of the sample. Prior Scientific designed a sample holder for the ImageProVision application to enable them to get the high-resolution images needed without compromising the samples.
The Prior stages come with a software development kit, making them easy to integrate with your software. Kulkarni concludes his experience working with Prior: “We had a very good experience handling Prior H101A, starting from packaging, very safe packaging, detailed instructions, ease of integration and online support from Prior team.”