Screening vaccine formulations for biological activity using fresh human whole blood

Brookes, Roger, Hakimi, Jalil, Ha, Yukyung, Aboutorabian, Sepideh, Ausar, Salvador, Hasija, Manvi, Smith, Steven G., Todryk, Stephen, Dockrell, Hazel and Rahman, Nausheen (2014) Screening vaccine formulations for biological activity using fresh human whole blood. Human Vaccines & Immunotherapeutics, 10 (4). pp. 1129-1135. ISSN 2164-554X

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Abstract

Understanding the relevant biological activity of any pharmaceutical formulation destined for human use is crucial. For vaccine-based formulations, activity must reflect the expected immune response, while for non-vaccine therapeutic agents, such as monoclonal antibodies, a lack of immune response to the formulation is desired. During early formulation development, various biochemical and biophysical characteristics can be monitored in a high-throughput screening (HTS) format. However, it remains impractical and arguably unethical to screen samples in this way for immunological functionality in animal models. Furthermore, data for immunological functionality lag formulation design by months, making it cumbersome to relate back to formulations in real-time. It is also likely that animal testing may not accurately reflect the response in humans. For a more effective formulation screen, a human whole blood (hWB) approach can be used to assess immunological functionality. The functional activity relates directly to the human immune response to a complete formulation (adjuvant/antigen) and includes adjuvant response, antigen response, adjuvant-modulated antigen response, stability, and potentially safety. The following commentary discusses the hWB approach as a valuable new tool to de-risk manufacture, formulation design, and clinical progression.

Item Type:	Article
Uncontrolled Keywords:	WBA, adjuvant modulation, vaccine, functionality, tuberculosis
Subjects:	C100 Biology
Department:	Faculties > Health and Life Sciences > Applied Sciences
Depositing User:	Ellen Cole
Date Deposited:	13 Feb 2014 16:59
Last Modified:	12 Oct 2019 18:29
URI:	http://nrl.northumbria.ac.uk/id/eprint/15401

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