Surfactant selection in biopharmaceutical product development
Publication Date
December 12, 2025
Creator
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
ethesis
Thesis Type
MRes
Supervisors
Subjects (LC)
Associated Schools / Departments
School of Biosciences (UK)
eprints ID
82740
UoN Repository URI
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Name
Genevieve Panton.pdf
Type
Full-text
Description
Examined
Size
1.13 MB
Format
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