Articles
Bioprocess Information Infrastructure
Article focuses on infrastructure selection and how hardware, software, and information systems form an ecosystem for an ideal knowledge management infrastructure for biopharmaceutical development and manufacturing. Simplicity, sustainability, and scalability can be achieved only when the trio is designed from a holistic perspective. The two-part article series explores related tools and technologies that biopharmaceutical companies can leverage to build an efficient mechanism for capturing and delivering valuable information. Part 1 of the series explores structured data capture and analysis tools, whereas Part 2 is dedicated to unstructured data capture and analytics. Part 2 concludes by focusing on how an integrated environment can be created to leverage on both structured and unstructured data, providing a single access window to enterprise information for end users.
Operational Excellence: More Data or Smarter Approach?
Achieving operational excellence is a growing goal among biopharmaceutical enterprises. Companies are investing heavily in software, data marts, and data integration to achieve operational excellence. The authors explore approaches for meeting operational-excellence goals, and discuss how to manage collected data with a risk-based approach for improved process understanding. Read More
Book Chapter
Knowledge management and process monitoring for biotech processes in QbD paradigm (In print)
Pharmaceutical processes are complex and highly variable in nature. The complexity and variability associated with these processes results in inconsistent and sometimes, unpredictable process outcomes. To deal with the complexity and understand the causes of variability in these processes, in-depth knowledge and thorough understanding of the process and the various factors affecting the process performance become critical. This makes knowledge management and process monitoring an indispensable part of the process improvement efforts for any pharmaceutical organization.