Sonja Schach, Tobias Eilert, Beate Presser, Marco Kunzelmann
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引用次数: 0
Abstract
Determining process variances in biopharmaceutical manufacturing is challenging due to limited data availability. To address this, we introduce a Bayesian hierarchical model designed for meta-analysis of process variance. This approach can improve process variance estimation by integrating data from multiple products, providing more reliable estimates of critical quality attributes in cases of data scarcity. Additionally, our model aids in evaluating process models, ensuring quality in process development. The paper demonstrates the new method using a simulation study, showcasing its potential to leverage historical data for both upstream and downstream phases of future CMC drug development. The new statistical model has great potential to expedite the market introduction of therapies while ensuring patient safety, allowing new treatments to reach patients more quickly without compromising quality or efficacy.
期刊介绍：
Aims
Bioengineering (ISSN 2306-5354) provides an advanced forum for the science and technology of bioengineering. It publishes original research papers, comprehensive reviews, communications and case reports. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. All aspects of bioengineering are welcomed from theoretical concepts to education and applications. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. There are, in addition, four key features of this Journal:
● We are introducing a new concept in scientific and technical publications “The Translational Case Report in Bioengineering”. It is a descriptive explanatory analysis of a transformative or translational event. Understanding that the goal of bioengineering scholarship is to advance towards a transformative or clinical solution to an identified transformative/clinical need, the translational case report is used to explore causation in order to find underlying principles that may guide other similar transformative/translational undertakings.
● Manuscripts regarding research proposals and research ideas will be particularly welcomed.
● Electronic files and software regarding the full details of the calculation and experimental procedure, if unable to be published in a normal way, can be deposited as supplementary material.
● We also accept manuscripts communicating to a broader audience with regard to research projects financed with public funds.
Scope
● Bionics and biological cybernetics: implantology; bio–abio interfaces
● Bioelectronics: wearable electronics; implantable electronics; “more than Moore” electronics; bioelectronics devices
● Bioprocess and biosystems engineering and applications: bioprocess design; biocatalysis; bioseparation and bioreactors; bioinformatics; bioenergy; etc.
● Biomolecular, cellular and tissue engineering and applications: tissue engineering; chromosome engineering; embryo engineering; cellular, molecular and synthetic biology; metabolic engineering; bio-nanotechnology; micro/nano technologies; genetic engineering; transgenic technology
● Biomedical engineering and applications: biomechatronics; biomedical electronics; biomechanics; biomaterials; biomimetics; biomedical diagnostics; biomedical therapy; biomedical devices; sensors and circuits; biomedical imaging and medical information systems; implants and regenerative medicine; neurotechnology; clinical engineering; rehabilitation engineering
● Biochemical engineering and applications: metabolic pathway engineering; modeling and simulation
● Translational bioengineering
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