Incorporate Real-Time Data Sharing Into Process Development

By Petter Mörée, Industry Principal, OSIsoft

In the early stages of drug development, process scientists leverage a wide range of equipment and analytical tools to collect vital data that helps them understand how a drug substance and drug product behaves in certain conditions. This information is then used to design a development and manufacturing process and implement process controls that ensure accuracy and consistent quality as a product transitions from research to clinical and commercial manufacturing. It also supports filings for new drug applications by serving as a key component of the batch record and regulatory approval review.

Most companies will say this process development knowledge does not just define the product ― it is the product. Therefore, it is important you consider solutions that could help scientists, engineers and analysts share their observations and collaborate on how to prevent issues later during the critical ― and more expensive ― stages of manufacture.