Author Archives: Michal Mleczko

Development of a Stand-Alone Monitoring Application for Purification Processes in Biomanufacturing

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The ability to monitor unit operations in biomanufacturing is essential because it enables early fault detection and effective root-cause analysis. Below, we present a case study on the development of a stand-alone, data-driven, process-monitoring application for a biomanufacturing purification process. We review the application’s functionality and highlight its utility using a few examples from commercial manufacturing of a therapeutic protein. Lessons learned from the development of that application also are presented. The progress and performance of a purification process have…

September 28, 2022

Establishing a Digital Platform for Data Science Applications in Biopharmaceutical Manufacturing

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Biopharmaceutical manufacturing consists of multiple processes with complex unit operations. Those include mammalian cell culture in upstream operations and downstream chromatography steps for removing impurities from production streams and purifying the therapeutic biological molecule (1). Biomanufacturers need enhanced understanding to ensure the process control and manufacture of safe and efficacious drug products. Process understanding also enables opportunities for improving manufacturing efficiency. Both process understanding and optimization can be facilitated by leveraging large volumes of biotechnology data — typically generated during…

February 4, 2022

Pathogen Safety Digital Platform for Biopharmaceuticals: The Journey from Ground to Cloud

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Digital transformation is at the heart of many biopharmaceutical companies’ strategies for ongoing success. However, the definition of digital transformation and what it consists of differ within the bioprocess industry (and might even vary within a single company), specifically as it applies to the overall value chain from R&D to clinical trials, manufacturing, supply chain, and eventually commercial operations. To provide a perspective on what digital transformation could look like in bioprocessing, we present a case study about an exploratory…

December 14, 2021

Multivariate Data-Driven Modeling for Continued Process Verification

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Continued process verification (CPV) is an integral part of process validation for the manufacture of human and animal drugs and biological products (1). It is designed to meet three primary goals: maintain a validated state of products, their processes, and related systems; enable continuous process improvements; and meet regulatory requirements for life-cycle validation. A CPV program for a biologic product entails regular collection of data related to critical process parameters (CPPs) and critical quality attributes (CQAs) and the preprocessing, analysis,…

October 28, 2021