Isuru Udugama

Dr. Isuru Udugama


Research Focus & Metrics

Academic Career Length

10Years (2017-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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12 December 2020 in Processes
Verified
Journal Article
Open access
PDF file
Ashish KumarAshish Kumar
Ashish Kumar
IUIsuru Udugama
Isuru Udugama
Carina L. GargaloCarina L. Gargalo
Carina L. Gargalo
Krist V. GernaeyKrist V. Gernaey
Krist V. Gernaey
Continuous manufacturing of biologics (biopharmaceuticals) has been an area of active research and development for many reasons, ranging from the demand for operational streamlining to the requirement of achieving obvious economic benefits. At the same time, biopharma strives to develop systems and concepts that can operate at similar scales for clinical and commercial production—using flexible infrastructures, such as single-use flow paths and small surge vessels. These developments should simplify technology transfer, reduce footprint and capital investment, and will allow to react readily to changing market pressures while maintaining quality attributes. Despite a number of clearly identified benefits compared to traditional batch processes, continuous bioprocessing is still not widely adopted for commercial manufacturing. This paper details how industry-specific technological, organizational, economic, and regulatory barriers that exist in biopharmaceutical manufacturing are hindering the adoption of continuous production processes. Based on this understanding, the roles of process systems engineering (PSE), process analytical technologies, and process modeling and simulation are highlighted as key enabling tools in overcoming these multi-faceted barriers in today’s manufacturing environment. Of course, we do recognize that there is also a need for a clear set of regulations to guide a transition of biologics manufacturing towards continuous processing. Furthermore, the role played by the emerging fields of process integration and automation as well as digitalization is explored, as these are the tools of the future to facilitate this transition from batch to continuous production. Finally, an outlook focusing on technology, management, and regulatory aspects is presented to identify key concerted efforts required to drive the broad adaptation of continuous manufacturing in biopharmaceutical processes.

21 August 2017 in Processes
Verified
Journal Article
Open access
PDF file
IUIsuru Udugama
Isuru Udugama
Seyed Soheil MansouriSeyed Soheil Mansouri
Seyed Soheil Mansouri
AMAleksandar Mitic
Aleksandar Mitic
Xavier Flores-AlsinaXavier Flores-Alsina
Xavier Flores-Alsina
Krist V. GernaeyKrist V. Gernaey
Krist V. Gernaey
Recovering valuable compounds from waste streams of bio-based production processes is in line with the circular economy paradigm, and is achievable by implementing “simple-to-use” and well-established process separation technologies. Such solutions are acceptable from industrial, economic and environmental points of view, implying relatively easy future implementation on pilot- and full-scale levels in the bio-based industry. Reviewing such technologies is therefore the focus here. Considerations about technology readiness level (TRL) and Net Present Value (NPV) are included in the review, since TRL and NPV contribute significantly to the techno-economic evaluation of future and promising process solutions. Based on the present review, a qualitative guideline for resource recovery from bio-based production processes is proposed. Finally, future approaches and perspectives toward identification and implementation of suitable resource recovery units for bio-based production processes are discussed.