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End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics.

Annette Medina Morales1, Alavattam Sreedhara2, Jakob Buecheler3

  • 1Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland, 20878, USA. annette.medina@astrazeneca.com.

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Summary
This summary is machine-generated.

This study outlines a consensus strategy for selecting and controlling surfactants in biopharmaceutical formulations, ensuring protein stability and product quality throughout manufacturing and storage.

Keywords:
Control strategyFormulation stabilityIn use compatibilityPoloxamerPolysorbateSurfactant

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Drug Delivery

Background:

  • Biopharmaceutical formulations commonly utilize surfactants for protein stabilization.
  • Surfactants can degrade, impacting drug product performance and stability.
  • A consensus approach to surfactant selection and control is needed.

Purpose of the Study:

  • To describe a common strategy for surfactant selection and control in protein-based therapeutics.
  • To build upon survey results from the AAPS Drug Product Handling community.
  • To identify key studies, common issues, mitigations, and rationale for surfactant use.

Main Methods:

  • Analysis of survey responses from 22 anonymized respondents.
  • Overview of surfactant stabilization principles.
  • Development of a strategy for surfactant level selection.
  • Discussion of risk identification, mitigation, and control strategies.

Main Results:

  • A general consensus exists on surfactant selection and control strategies for biopharmaceuticals.
  • Understanding and controlling surfactant material attributes is crucial for consistent quality.
  • Mitigation strategies address risks from host cell proteins, manufacturing, and storage.

Conclusions:

  • The described strategy ensures consistent use of high-quality surfactants in drug substance/drug product manufacturing.
  • Effective control strategies enhance protein stability and drug product performance.
  • Mitigation plans address potential risks during manufacturing, storage, and in-use conditions.