The Road to HPLC2018 Part VI: Continuous Evolution
The pharmaceutical industry is looking to continuous manufacturing to increase efficiency and ensure safety – can separation technology keep up?
Todd Maloney |
This year at the 47th International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC2018), there will be several lectures and a tutorial session discussing best practice for integrating process analytical technologies (PATs) for continuous manufacturing.
Generally defined as a series of unit operations where materials produced in each process step are continuously transferred to the next process step for forward processing, continuous manufacturing is considered by many to be the future of pharmaceutical manufacturing. To be successful, continuous manufacturing requires the convergence of chemical engineering, analytical and organic chemistry, and process automation, to deliver robust, flexible manufacturing platforms.
A key attribute of any continuous manufacturing process is the ability to monitor product quality throughout the process. Combinations of parametric controls and PATs are frequently deployed to enable on-line monitoring of product quality attributes in continuous processes, including simple sensors (conductivity, temperature, pH) and optical spectroscopy (IR, Raman, UV-Vis). However, as pharmaceutical and biopharmaceutical processes continue to increase in complexity, the demand for information-rich experiments with the ability to track low-level impurities is driving the integration of HPLC for on-line process monitoring.
There are clearly many challenges associated with moving HPLCs into chemical or biological processing areas, including the physical space the instrument occupies, the sampling interface to the process, data management, and connectivity between analytical and engineering control systems. ATEX-rated enclosures are required to operate analytical instruments in a production environment, and can add considerable cost and complexity towards implementing on-line HPLC. Process sampling interfaces for on-line HPLC must ensure a representative sample is collected and that the process is not disturbed during sampling, plus sampling interfaces require thorough understanding of sample concentration, solubility, stability, material compatibility and matrix effects, to minimize the risk of fouling the sampling interface or HPLC. Communication and control between chromatography data systems (CDS) and distributed control systems (DCS) is vital to implementing on-line HPLC. Direct communication between the CDS and DCS enables on-line analysis at any time, while transfer and visualization of chromatographic data in the DCS improves process understanding and control.
At HPLC 2018, speakers from Eli Lilly and Company and GlaxoSmithKline will highlight applications of on-line HPLC in development and commercial-scale continuous manufacturing of small molecule pharmaceuticals – with speakers from Amgen, Biogen, and Merck highlighting recent applications for enhanced process control in biopharmaceutical production. The aforementioned challenges will be front and center, as each speaker presents their approach to process sampling and connectivity between the analytical and continuous manufacturing environments. Additionally, Eli Lilly will introduce novel process sampling interfaces for on-line HPLC with automated sampling, quench, and dilution. These innovative sampling interfaces enable on-line HPLCs to operate hundreds of feet away from a process, removing the instrument from the production floor, eliminating the need for ATEX enclosures, and enabling sampling and instrument control from the process DCS.
I cannot think of a better venue than HPLC2018 for these speakers to share their success stories, and to discuss the current and future challenges of on-line HPLC in a continuous manufacturing environment. With so many of the world’s separation science experts in one location, there are sure to be some intriguing conversations and insights to continue instrument innovation and integration in the continuous manufacturing environment.
HPLC 2018 takes place on 29 July to 2 August in Washington, DC. HPLC2018.org