Biotherapeutic Analysis: Precision Characterization and Quality Control

Dear Colleagues,

We are pleased to invite you to contribute to this Special Issue on “Biotherapeutic Analysis: Precision Characterization and Quality Control” in Biomolecules.

The biotherapeutics landscape is undergoing unprecedented transformation as complex biologics, cell therapies, and gene therapies move from bench to bedside. Ensuring the safety, efficacy, and quality of these sophisticated products requires equally sophisticated analytical approaches. Traditional characterization methods, while foundational, are being challenged by the complexity of next-generation therapeutics and the demands of modern regulatory frameworks. The integration of advanced analytical technologies is revolutionizing how we characterize and control biotherapeutic products. Furthermore, the incorporation of artificial intelligence, machine learning, and digital connectivity into analytical workflows promises to accelerate development timelines while maintaining the rigorous quality standards essential for patient safety. This convergence of analytical innovation, automation, and intelligent data analysis represents a critical frontier in biopharmaceutical science, with profound implications for global health and regulatory science.

This Special Issue aims to showcase cutting-edge research and comprehensive reviews that advance the science and practice of biotherapeutic characterization and quality control. We seek contributions that demonstrate novel analytical approaches, innovative applications of established techniques, and forward-thinking perspectives on the future of biotherapeutic analysis. The scope encompasses the full spectrum of analytical challenges in biologics development and manufacturing—from early-stage characterization to process analytical technology (PAT), release testing, and stability assessment. We are particularly interested in work that bridges analytical science with regulatory requirements, addresses the unique challenges of advanced therapy medicinal products (ATMPs), and explores the role of automation and artificial intelligence in creating more efficient, robust, and predictive quality systems. This Special Issue aligns with Biomolecules’ focus on the structure, function, and analysis of biological macromolecules, with direct relevance to proteins, nucleic acids, and complex biological systems that form the basis of modern therapeutics.

In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following:

• Advanced mass spectrometry techniques for biologics quality assessment;
• NGS-based analytical methods for cell and gene therapy products;
• Process analytical technology (PAT) and real-time release testing strategies;
• Artificial intelligence and machine learning applications in biotherapeutic analysis;
• Automated and high-throughput analytical platforms for biologics;
• Critical quality attribute (CQA) identification and monitoring strategies;
• Comparability and biosimilarity assessment methodologies;
• Analytical challenges in cell therapy manufacturing and characterization;
• Gene therapy vector characterization and quality control;
• Regulatory science perspectives on analytical method validation and acceptance;
• Digital transformation and data integrity in biopharmaceutical quality systems;
• Post-translational modification analysis;
• Host cell protein and process-related impurity detection methods;
• Emerging analytical technologies for next-generation biotherapeutics.

We look forward to receiving your contributions.

Prof. Dr. Jared Auclair
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Biomolecules is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• biotherapeutics
• analytical characterization
• quality control
• mass spectrometry
• cell therapy
• gene therapy
• biologics
• process analytical technology
• regulatory science