ArticleNature biotechnology2004
Characterizing biological products and assessing comparability following manufacturing changes.
Article in Nature biotechnology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 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
73 citing papers in PubMed.
- Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2015Trial
- A General Strategy to Compare Stability Slopes of Biologics Using Short-Term data from Post-Change Batches Versus Long-Term Data from Pre-Change Batches.Pharmaceutical research · 2026Article
- 3D bioprinting the human chest wall: Fiction or fact.npj biomedical innovations · 2024Review
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Multivalent Aptamer-Based Lysosome-Targeting Chimeras (LYTACs) Platform for Mono- or Dual-Targeted Proteins Degradation on Cell Surface.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Tools shaping drug discovery and development.Biophysics reviews · 2022Review
- Protposer: The web server that readily proposes protein stabilizing mutations with high PPV.Computational and structural biotechnology journal · 2022Article
- High-throughput N-glycan screening method for therapeutic antibodies using a microchip-based DNA analyzer: a promising methodology for monitoring monoclonal antibody N-glycosylation.Analytical and bioanalytical chemistry · 2021Article
- Efficacy of minute virus of mice (MVM) inactivation utilizing high temperature short time (HTST) pasteurization and suitability assessment of pasteurized, concentrated glucose feeds in Chinese hamster ovary (CHO) cell expression systems.Engineering in life sciences · 2021Article
- Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution.Pharmaceutical research · 2020Article
- Similar biologics in India: A story of access or potential for compromise?The Indian journal of medical research · 2020Review
- An NMR-Based Similarity Metric for Higher Order Structure Quality Assessment Among U.S. Marketed Insulin Therapeutics.Journal of pharmaceutical sciences · 2020Article
- Reduction of charge variants by CHO cell culture process optimization.Cytotechnology · 2020Article
- Article
- Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis.Drug safety · 2019Review
- Hematopoietic Stem Cell Transplantation for Mucopolysaccharidoses: Past, Present, and Future.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019Review
- Aptamers as quality control tool for production, storage and biosimilarity of the anti-CD20 biopharmaceutical rituximab.Scientific reports · 2019Article
- Content/Potency Assessment of Botulinum Neurotoxin Type-A by Validated Liquid Chromatography Methods and Bioassays.Toxins · 2019Article
- Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective.The AAPS journal · 2018Article
- Enhancing Sensitivity of Liquid Chromatography-Mass Spectrometry of Peptides and Proteins Using Supercharging Agents.International journal of mass spectrometry · 2018Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Changes in production methods of a biological product may necessitate an assessment of comparability to ensure that these manufacturing changes have not affected the safety, identity, purity, or efficacy of the product. Depending on the nature of the protein or the change, this assessment consists of a hierarchy of sequential tests in analytical testing, preclinical animal studies and clinical studies. Differences in analytical test results between pre- and post-change products may require functional testing to establish the biological or clinical significance of the observed difference. An underlying principle of comparability is that under certain conditions, protein products may be considered comparable on the basis of analytical testing results alone. However, the ability to compare biological materials is solely dependent on the tests used, since no single analytical method is able to compare every aspect of protein structure or function. The advantages and disadvantages of any given method depends on the protein property being characterized.
Indexed as
Identifiers
15529163What 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.