Applying process analytical technologies (PAT) for biotherapeutic development and manufacturing is possible because of technological, economic, and regulatory advantages across the industry. Typically, chromatographic, spectroscopic, and/or mass spectrometric sensors are integrated into upstream and downstream unit operations in‐line, on‐line, or at‐line to enable real‐time monitoring and control of the processes.
However, despite their widespread use, a holistic business value assessment of PAT has not been properly addressed in biologics.
This has led BioPhorum to publish a Systematic assessment of process analytical technologies for biologics, which reviews the current usage and perceived value of PAT in the biopharmaceutical industry. It is the first time this type of assessment has been performed across manufacturing and development spaces.
The team used an industry‐wide survey where the views of subject matter experts on PAT tools were collected, assessed, and ranked. The team also evaluated PAT tools for their technological attributes based on predefined criteria (e.g., better process understanding) and business attributes (e.g., simplicity of implementation).
The survey results demonstrated that on‐line liquid chromatography, in‐line Raman, and gas analysis techniques have a high business value, especially at the production bioreactor unit operation of upstream processing. Also, in‐line variable path spectroscopy, on‐line liquid chromatography, multiangle light scattering, and automated sampling are highly valued in Protein A purification and the polishing steps of the downstream process.
The paper also explains how to develop and implement some PAT tools. While their selection is ultimately governed by process control strategy, the insights from this assessment will help senior management to have the confidence to invest and strategically implement PAT to maximize business value. Vendors and public research organizations will also benefit from the paper when assessing industry needs and prioritizing product development and research.
Using PAT correctly will allow companies to analyze a process to reduce manufacturing risks, highlighting issues sooner and enabling their quick resolution. It can also give confidence if a process is working well. Published in Biotechnology and Bioengineering, the results of this study will help current practitioners of PAT and those new to the field to gauge, prioritize and steer their projects for success.