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October 1, 2025Biological Products Prevention Diagnosis TreatmentOpen Access

Excipients in biological medicinal products: Functional classification, stability issues, and analytical quantitation approaches

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Authors

AMA. S. MineroORO. B. RounovaISI. M. Shcherbachenko

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Overview

Analysis reveals stability issues and quantitation methods for excipients in biological products, suggesting enhanced quality control.

Key Points

  • Selection of excipients in biological products requires careful evaluation of potential adverse effects.
  • Liquid chromatography techniques are essential for quantifying excipients, ensuring product quality in biological products.
  • Innovative analytical methods can minimize risks associated with excipient degradation and improve compliance testing.
  • A mathematical model aids in selecting excipient compositions, crucial for the development of safe biological products.

Cite This Study

Minero et al. (2025) studied this question.

synapsesocial.com/papers/68dd91cffe798ba2fc498cb1https://doi.org/10.30895/2221-996x-2025-25-3-307-320
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Also Consider

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  1. 1Analysis of the use of excipients in medicines of biological origin2024 · 1 citations
  2. 2Exploring Experimental and Statistical Approaches to Control Oversensitivity of In Vitro Permeability to Excipient Effects2025 · 1 citations
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  4. 4Naturally derived excipients in injectable nanomedicines: a systematic review of pharmacokinetic performance, regulatory readiness, and future quality by design perspectives2026
  5. 5Excipients Used in Pediatric Oral Dosage Forms: Challenges and Perspectives for Safe Hospital Practice2026