The article, ON-LINE PROCESS CONTROL: Automating the Control of Process-Scale Purification Columns Using On-Line Liquid Chromatography describes how Lilly used liquid chromatography to measure product purity in near real-time. This is an example of how pharmaceutical and biotech manufacturers are using the guidance from the FDA’s Process Analytical Technologies (PAT) initiative to improve their operations. I’ll warn you that this article is pretty technical and suited best for those Chemical Engineers among us.
I ran this article by our Life Sciences industry experts to see if they were involved in this or any similar efforts. Lead engineer Brian Crandall, whom you may recall from an earlier post, sent me a note back how his team had recently completed a project for a biotech manufacturer. They wanted an integrated way for their operators to interact with the chromatography columns with the goal of achieving process repeatability and more quantifiable product quality.
Brian and his team developed a solution based upon the ISA S88 modular standard. The major pieces of equipment used on the chromatography skid including dilution control, feed pumps, columns and valve arrays were grouped into processing categories to provide the operators a way to efficiently operate this skid. They can start new operations, hold ones that are currently running, and respond to abnormal processing conditions to take corrective action before quality is impacted.
Also critical was collecting the data from the chromatographs to do analysis around product optical density trends and equipment performance metrics. The DeltaV Batch automation system was also integrated with manufacturing execution system (MES) software to provide material genealogy with the manual and automated process information. This genealogy record included the materials transferred into and out of the chromatography skid. The solution for this information integration was based upon the ISA S95 information standard between enterprise and control systems.
To tie this information back to the business objectives of repeatability and improved quality, Brian and the team created a final batch report that displays the complete product history through the chromatography process. As stated on the PAT site:
The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
This design, integration and implementation work by Brian and team sounds exactly like what this goal is meant to achieve.
Update: Welcome Wall Street Journal readers!