Biopharmaceutical analysis - current analytical challenges, limitations, and perspectives

• Type: Another Publication in an International Scientific Journal
• Date: 2025

Authors

Cunha, DR (Author) Other; M. Beatriz Q. Garcia (Author) FFUP; Marcela A Segundo (Author) FFUP

Journal

Title: Analytical and Bioanalytical Chemistry

ISSN: 1618-2642

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 0 Citations

Scopus - 0 Citations

Other information

Authenticus ID: P-019-VZK

DOI: 10.1007/s00216-025-06036-2

Abstract (EN): Biopharmaceutical analysis is essential for ensuring the quality, safety, and efficacy of these medicines. Nonetheless, it faces significant challenges due to the complexity of these molecules and the strict regulatory standards. This work explores the strengths, limitations, opportunities, and threats in biopharmaceutical analysis, focusing on the challenges and emerging analytical technologies and their impact on biopharmaceutical development and quality control. Key challenges identified include the complexity and heterogeneity of biopharmaceuticals leading to the requirement for a broad spectrum of analytical methods, the high cost of the required analytical instrumentation, and the need for skilled professionals to implement advanced analytical techniques. Integrating artificial intelligence-driven data analysis, automation, and multi-omics approaches can significantly improve analytical precision and efficiency. However, regulatory barriers and financial constraints remain critical obstacles to widespread adoption. This work highlights the need for industry-wide collaboration to standardize methodologies and regulations, improve data integrity, and facilitate regulatory acceptance by reviewing the last 5 years of biopharmaceutical-related works. Ultimately, the continued development of biopharmaceutical analysis, driven by technological advancements and strategic investments, is crucial for biopharmaceutical development, enhancing manufacturing efficiency, and ensuring broader access to high-quality biopharmaceuticals.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 22