ArticleThe AAPS journal2017
A View on the Importance of "Multi-Attribute Method" for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy.
Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed.
- Development and Integrated Application of the Multi-Attribute Method (MAM) in Quality Control of Biotechnological Drugs.Biotechnology and bioengineering · 2026Review
- Protein Therapeutic Quality Control Using Multi-Attribute Method (MAM): Challenges and Current Practice in cGMP Environments.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Review
- Qualification and Implementation of a Robust Multi-Attribute Method Platform Across Multiple Laboratories for High-Resolution Process Characterization of Biopharmaceutical Products.Pharmaceuticals (Basel, Switzerland) · 2026Article
- The Multi-Attribute Method (MAM), An Advanced LC-MS Approach for Protein A Resin Performance and Lifecycle Evaluation.Antibodies (Basel, Switzerland) · 2026Article
- Article
- Intact Mass Spectrometry Analysis of Immuno-Isolated Human Therapeutic Antibodies from Serum.Methods in molecular biology (Clifton, N.J.) · 2026Article
- Article
- Multi-attribute monitoring (MAM) methodology for glycosylated subunit vaccines.Scientific reports · 2025Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Assessment of monoclonal antibody glycosylation: a comparative study using HRMS, NMR, and HILIC-FLD.Analytical and bioanalytical chemistry · 2024Article
- A candidate antibody drug for prevention of malaria.Nature medicine · 2024Article
- Diagnostic utility of N-terminal TMPP labels for unambiguous identification of clipped sites in therapeutic proteins.Scientific reports · 2023Article
- Addressing Acid-Catalyzed Deamidation and the Solubility of Hydrophobic Peptides in Multi-Attribute Method Workflows.Analytical chemistry · 2023Article
- Evolution of Vaccines Formulation to Tackle the Challenge of Anti-Microbial Resistant Pathogens.International journal of molecular sciences · 2023Review
- Multi-Attribute Monitoring Method for Process Development of Engineered Antibody for Site-Specific Conjugation.Journal of the American Society for Mass Spectrometry · 2023Article
- Innovative Metrics for Reporting and Comparing the Glycan Structural Profile in Biotherapeutics.Molecules (Basel, Switzerland) · 2023Article
- Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Optimized Multi-Attribute Method Workflow Addressing Missed Cleavages and Chromatographic Tailing/Carry-Over of Hydrophobic Peptides.Analytical chemistry · 2022Article
- Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study.Journal of the American Society for Mass Spectrometry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Today, we are experiencing unprecedented growth and innovation within the pharmaceutical industry. Established protein therapeutic modalities, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, are being used to treat previously unmet medical needs. Novel therapies such as bispecific T cell engagers (BiTEs), chimeric antigen T cell receptors (CARTs), siRNA, and gene therapies are paving the path towards increasingly personalized medicine. This advancement of new indications and therapeutic modalities is paralleled by development of new analytical technologies and methods that provide enhanced information content in a more efficient manner. Recently, a liquid chromatography-mass spectrometry (LC-MS) multi-attribute method (MAM) has been developed and designed for improved simultaneous detection, identification, quantitation, and quality control (monitoring) of molecular attributes (Rogers et al. MAbs 7(5):881-90, 2015). Based on peptide mapping principles, this powerful tool represents a true advancement in testing methodology that can be utilized not only during product characterization, formulation development, stability testing, and development of the manufacturing process, but also as a platform quality control method in dispositioning clinical materials for both innovative biotherapeutics and biosimilars.
Indexed as
Identifiers
29192343What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.