Merck and Agilent to advance process analytical technologies for downstream processing
The biopharmaceutical industry needs to evolve and digitalize the next generation of bioprocessing to increase accessibility of biologics, said the companies.
They expect the combination of Merck’s bioprocess portfolio with Agilent’s advanced analytical products to extend real-time monitoring and automated process control of critical process parameters (CPPs) and critical quality attributes (CQAs) to downstream processing, helping customers produce biological drugs faster, with greater confidence, and at lower cost.
“PAT can reduce the burden of off-line testing, help to eliminate process hold steps and move the needle towards making real-time release a reality.
“Through real-time monitoring and automated process control of CPPs and CQAs, customers can increase their process understanding, which, in turn, can lead to more consistent product quality and increased assurance of product safety and efficacy. It can also improve process productivity resulting in faster release and potentially reduced manufacturing costs,” said Stacy Shollenberger, senior manager, PAT, Merck.
The adoption of PAT has been slow in both downstream and upstream bioprocessing, she told BioPharma-Reporter.
“As the industry shifts towards continuous cell culture process runs, PAT tools are being integrated upstream to monitor the process and enable feedback/feedforward control. However, the deployment of PAT tools in the downstream process (DSP) has remained less of a focus due to its step-by-step nature.
"With the industry shifting towards implementing continuous manufacturing, PAT tools for accurate, real-time analytics will be required across the entire bioprocessing workflow.”
Addressing continuous manufacturing needs
She said that downstream analytical analysis is predominately done in an off-line fashion, where a sample is taken from the process stream and sent to a quality control lab for analysis.
“Analytical analysis can often take several weeks, requiring intermediate hold steps to be built into the process. As the industry moves toward a continuous manufacturing process, analytics will need to be moved into an in-line or on-line orientation so that process monitoring and control can be performed in real-time. While the analytical technologies to monitor the downstream process exist today, the challenge lies in the integration of the analytical tools into the bioprocessing workflow from both a physical and a digital perspective.”
Moreover, global regulatory authorities are advocating for the use of PAT in pharma processes, said Shollenberger.
“Due to high regulatory requirements, the pharmaceutical and biopharmaceutical industries have been slow to implement modern quality techniques within their manufacturing processes to achieve manufacturing efficiencies. However, there is a significant need to increase process knowledge and understanding within these industries. PAT helps pharma and biopharma companies produce products with more flexibility and at a lower cost while ensuring consistent end-product quality.”