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Panton, Genevieve (2025) Surfactant selection in biopharmaceutical product development. MRes thesis, University of Nottingham.

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Abstract

Biopharmaceuticals represent one of the fastest growing areas in the pharmaceutical industry, with

monoclonal antibodies (mAbs) dominating recent approvals. However, their inherent instability and high

surface activity pose formulation challenges. Throughout their manufacture, transport and

administration, mAb products encounter multiple stresses and interfaces that can induce aggregation

and visible and sub-visible particles, which are linked to safety risks such as immunogenicity. To address

this, non-ionic surfactants such as polysorbates and poloxamers are used due to their effectiveness and

history of use. Despite their success, concerns remain around their degradation propensity,

heterogeneity and safety. Novel surfactants are under investigation to overcome these issues, with

advantages including tunable and modular structures, improved degradation resistance, and potential

for rational design. However, their use is limited by complex regulatory pathways and the need for

extensive toxicological and compatibility studies. Ultimately, surfactant selection must be guided by a

careful, case-by-case risk–benefit evaluation, balancing stability, safety and regulatory considerations.

While novel excipients show promise, polysorbates and poloxamers will likely remain central to mAb

product formulations, supported by mitigation strategies and ongoing optimisation.

Item Type:	Thesis (University of Nottingham only) (MRes)
Supervisors:	Harding, Stephen Darton, Nicholas
Keywords:	Biopharmaceuticals; Monoclonal antibodies; Non-ionic surfactants
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Faculties/Schools:	UK Campuses > Faculty of Science > School of Biosciences
Item ID:	82740
Depositing User:	Panton, Genevieve
Date Deposited:	12 Dec 2025 04:40
Last Modified:	12 Dec 2025 04:40
URI:	https://eprints.nottingham.ac.uk/id/eprint/82740

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