Journal
PROCESSES
Volume 9, Issue 11, Pages -Publisher
MDPI
DOI: 10.3390/pr9111996
Keywords
surface plasmon resonance (SPR); bioprocess; monitoring; biosensor; quality by design (QbD); process analytical technology (PAT); biotherapeutics production; vaccines production
Categories
Funding
- Natural Sciences and Engineering Research Council of Canada
- TransMedTech Institute(NanoBio Technology Platform)
- Canada First Research Excellence Fund
Ask authors/readers for more resources
Biomanufacturers are urged by regulatory agencies to shift towards a quality by design or quality by control framework, requiring powerful analytical tools and sensors for real-time monitoring. Surface plasmon resonance (SPR) biosensors show promise in improving bioprocess monitoring in biotherapeutics production, vaccine monitoring, and contaminant detection. Limitations of SPR in monitoring roles can be addressed through advancements in hardware and SPR response modeling, enabling more efficient production control and potential for product monitoring from early production to downstream processing.
Biomanufacturers are being incited by regulatory agencies to transition from a quality by testing framework, where they extensively test their product after their production, to more of a quality by design or even quality by control framework. This requires powerful analytical tools and sensors enabling measurements of key process variables and/or product quality attributes during production, preferably in an online manner. As such, the demand for monitoring technologies is rapidly growing. In this context, we believe surface plasmon resonance (SPR)-based biosensors can play a role in enabling the development of improved bioprocess monitoring and control strategies. The SPR technique has been profusely used to probe the binding behavior of a solution species with a sensor surface-immobilized partner in an investigative context, but its ability to detect binding in real-time and without a label has been exploited for monitoring purposes and is promising for the near future. In this review, we examine applications of SPR that are or could be related to bioprocess monitoring in three spheres: biotherapeutics production monitoring, vaccine monitoring, and bacteria and contaminant detection. These applications mainly exploit SPR's ability to measure solution species concentrations, but performing kinetic analyses is also possible and could prove useful for product quality assessments. We follow with a discussion on the limitations of SPR in a monitoring role and how recent advances in hardware and SPR response modeling could counter them. Mainly, throughput limitations can be addressed by multi-detection spot instruments, and nonspecific binding effects can be alleviated by new antifouling materials. A plethora of methods are available for cell growth and metabolism monitoring, but product monitoring is performed mainly a posteriori. SPR-based biosensors exhibit potential as product monitoring tools from early production to the end of downstream processing, paving the way for more efficient production control. However, more work needs to be done to facilitate or eliminate the need for sample preprocessing and to optimize the experimental protocols.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available