Characterization and Quality Control of Biopharmaceuticals Using the Multi-Attribute Method (MAM): Advantages and Challenges
A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Biopharmaceuticals".
Deadline for manuscript submissions: 31 May 2025 | Viewed by 186
Special Issue Editor
Interests: mass spectrometry (MS); LC-MS, LC-MSMS; intact mass analysis; peptide mapping (PM); top-down sequencing (TDS); middle-up analysis; subunit analysis; analytical characterization; quality control (QC); post-translational modifications (PTMs); multi-attribute method (MAM); new peak detection (NPD); critical quality attribute (CQA); product quality attributes (PQAs); quality by design (QbD); biopharmaceuticals; monoclonal antibodies (mAb); cell and gene therapy (CGT); adeno-associated virus (AAV); biosimilar; glycosylation; deamidation; vaccines; MRNA; proteins; peptides; oligonucleotides; host cell proteins (HCPs); impurities; biomarkers; bioassays; bioactivity; potency; structure–activity relationship (SAR)
Special Issue Information
Dear Colleagues,
The biopharmaceutical industry is rapidly evolving, bringing complex biologics such as monoclonal antibodies (mAbs) and fusion proteins to the forefront of modern medicine. However, the intricate structures of these therapeutics pose significant challenges for characterization and quality control (QC), which traditional analytical methods often struggle to address. The Multi-Attribute Method (MAM) is emerging as a critical solution, offering detailed and accurate profiling of product quality attributes (PQAs) and streamlining QC workflows by consolidating multiple analyses into a single approach. Despite MAM’s advantages, adoption barriers remain, including the need for robust data analysis, regulatory acceptance, and standardized workflows.
Scope and Objectives of this Special Issue: This Special Issue compiles the latest advancements, applications, and insights regarding the MAM’s role within the biopharmaceutical sector, focusing on four primary areas:
- Advanced MAM Workflows: Innovative methodologies and case studies illustrating the MAM’s integration into biotherapeutic development and manufacturing;
- Regulatory Insights: Perspectives on the regulatory acceptance of the MAM and its alignment with current Good Manufacturing Practices (cGMPs);
- Technical Challenges and Solutions: In-depth discussions on technical hurdles encountered during MAM implementation, along with practical strategies to address them;
- Future Directions: Emerging trends and the evolving role of the MAM as the biopharmaceutical landscape continues to advance.
Conclusions: As the biopharmaceutical industry progresses, adopting sophisticated analytical tools like the MAM is vital for maintaining the rigorous quality and safety standards required for biologics.
This Special Issue will serve as a valuable resource for researchers, industry professionals, and regulatory stakeholders, providing a comprehensive look into MAM’s transformative potential. We hope that these contributions inspire continued innovation and collaboration, ultimately enabling the development of safer, more effective biotherapeutic products.
Dr. Jingzhong Guo
Guest Editor
Manuscript Submission Information
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Keywords
- analytical characterization
- critical quality attribute (CQA)
- the multi-attribute method (MAM)
- new peak detection (NPD)
- post-translational modifications (PTM)
- product quality attribute (PQA)
- peptide mapping (PM)
- quality by design (QbD)
- quality control (QC)
- structure–activity relationship (SAR)
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