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April 8, 2026Biotechnology Journal

Advanced Extractables and Leachables Assessment of Microcarriers Used for Adherent Cell Cultures

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Authors

AHArmin HaukIPIna PahlJAJonas Austerjost

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Overview

Demonstrates the safety of microcarriers used in cell therapy by assessing extractables and leachables, indicating their low risk for patient safety.

Key Points

  • The aim is to assess the extractables and leachables from microcarriers in cell culture applications to ensure patient safety.
  • Analyzed styrene-based microcarriers qualitatively and quantitatively according to USP 〈665〉.
  • Conducted kinetic investigations and fitted data to an algorithm for dynamic modeling of extractables.
  • Modeled the temporal exposure to process equipment-related leachables in a hypothetical cell therapy application.
  • PERLs released from microcarriers in a dynamic system do not influence product quality at harmful levels.
  • Concentrations of leachables remain below levels that could negatively affect human therapeutic cells.
  • Dynamic systems with partial medium exchange show significantly lower concentrations of leachables compared to static conditions.

Cite This Study

Hauk et al. (2026) studied this question.

synapsesocial.com/papers/69d5f14b74eaea4b11a7ae96https://doi.org/10.1002/biot.70220
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