Issue link: https://www.e-digitaleditions.com/i/1248960
8 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m Development The promise of PAT During a bioprocess, many critical quality attributes (CQAs) and process parameters are monitored to en- sure product quality. In traditional processes, samples are taken frequently by manual means and brought into analytical laboratories for testing to ensure product quality has been met; this carries forward throughout the process. These methods are labor-intensive, allow for operator error, and do not deliver real-time data, which inhib- its their use in continuous bioprocesses, according to Botonjic-Sehic. "Real-time data is extremely important for identifying and mitigating process failures immedi- ately and is necessary to complement the advances in continuous processing," she asserts. To help overcome this industry challenge, Pall Biotech has been focusing on the evaluation and development of new process analytical technologies (PATs) that can measure CQAs in real-time. "The goal is to remove any lag between identifying and mitigating a discrepancy in the process by bringing monitoring closer to the process. By automating analytics and enabling the automatic tracking and processing of data, integrity, and security are built into the process," observes Botonjic-Sehic. The company, she adds, is focusing on the most de- manding CQAs throughout the bioprocess. "We do not want to just bring new equipment to the process suite for the sake of it; we want to ensure that we are bring- ing measurements closer to the process with intelligent and intuitive designs. While there is still not a 'one-for- all' approach, different analytical techniques are being evaluated to meet application needs with as much func- tionality as possible," Botonjic-Sehic says. The value of automation In addition to real-time data, automation of both the bioprocess and the data collection and analysis, which can be leveraged by a computerized platform to provide real-time feedback control of the biopro- cess, can provide an even deeper level of product quality, according to Botonjic-Sehic. Pall Biotech has implemented this approach through a framework capable of controlling the process equipment and analytical instruments, au- tomating the data collection and analysis, and feed- ing the data into developed chemometric models to enable continuous monitoring and control of bioprocesses. An integrated human-machine interface (HMI) enables the operator to monitor the process and in- tervene as needed, ensuring optimum process con- trol and product quality, according to Botonjic-Se- hic. She notes that the automated documentation of critical process parameters and CQAs also improves the efficiency of process maintenance, while the che- mometric model of each unit operation improves productivity at each step. "This real-time feeding of automated collected data into chemometric model- ing results in a truly continuous approach to process control and quality," Botonjic-Sehic asserts. "Our objective is to have fully automated and in- tegrated control capabilities from end-to-end of the bioprocess, capable of immediately detecting any deviation in either the process or the product, with an HMI giving the operator the tools needed to mit- igate those deviations, saving time, reducing batch failures, and improving overall product quality and consistency at every scale," concludes Botonjic-Sehic. Digital advances have increasing impacts Advances in digital technology are also contributing to greater quality for data monitoring and control sys- tems. For instance, cloud-based storage environments are making it easier to bring together data generated on