ReviewBioMed research international2015
Early implementation of QbD in biopharmaceutical development: a practical example.
Review in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed.
- Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes.AAPS PharmSciTech · 2026Review
- Blockchain-enabled quality by design system for clinical trials.Frontiers in medicine · 2025Article
- Evaluation of a novelEuropean journal of nuclear medicine and molecular imaging · 2024Article
- Designing of an extract production protocol for industrial application of cell-free protein synthesis technology: Building from a current best practice to a quality by design approach.Engineering biology · 2023Review
- Improved Time Resolved KPI and Strain Characterization of Multiple Hosts in Shake Flasks Using Advanced Online Analytics and Data Science.Bioengineering (Basel, Switzerland) · 2022Article
- Assessment of Therapeutic Antibody Developability by Combinations of In Vitro and In Silico Methods.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Immunogenicity Challenges Associated with Subcutaneous Delivery of Therapeutic Proteins.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- Pharmacokinetic Engineering of OX40-Blocking Anticalin Proteins Using Monomeric Plasma Half-Life Extension Domains.Frontiers in pharmacology · 2021Article
- QSAR Implementation for HIC Retention Time Prediction of mAbs Using Fab Structure: A Comparison between Structural Representations.International journal of molecular sciences · 2020Article
- Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs.Journal of clinical and translational science · 2020Review
- The uniqueness of flow in probing the aggregation behavior of clinically relevant antibodies.Engineering reports : open access · 2020Article
- Mitigation of liquid-liquid phase separation of a monoclonal antibody by mutations of negative charges on the Fab surface.PloS one · 2020Article
- Using extensional flow to reveal diverse aggregation landscapes for three IgG1 molecules.Biotechnology and bioengineering · 2018Article
- Affibody molecules as engineered protein drugs.Experimental & molecular medicine · 2017Review
- Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development.The AAPS journal · 2017Review
- Article
- Article
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- A comparison of biophysical characterization techniques in predicting monoclonal antibody stability.mAbsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In drug development, the "onus" of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or "binding" functionality). Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a "holistic" interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole. In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way. We define specific areas of risk and how they can impact product quality in a broad sense, including essential aspects such as product efficacy and patient safety. Emerging industry practices around developability are introduced, including some specific examples of applications to biotherapeutics. Furthermore, we suggest some potential workflows to illustrate how developability strategies can be introduced in practical terms during early drug development in order to mitigate risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain. Finally, we also discuss how the implementation of such methodologies could accelerate the access of new therapeutic treatments to patients in the clinic.
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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.