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Harnessing the potential of machine learning for advancing "Quality by Design" in biomanufacturing.

ABSTRACT: Ensuring consistent high yields and product quality are key challenges in biomanufacturing. Even minor deviations in critical process parameters (CPPs) such as media and feed compositions can significantly affect product critical quality attributes (CQAs). To identify CPPs and their interdependencies with product yield and CQAs, design of experiments, and multivariate statistical approaches are typically used in industry. Although these models can predict the effect of CPPs on product yield, there is room to improve CQA prediction performance by capturing the complex relationships in high-dimensional data. In this regard, machine learning (ML) approaches offer immense potential in handling non-linear datasets and thus are able to identify new CPPs that could effectively predict the CQAs. ML techniques can also be synergized with mechanistic models as a 'hybrid ML' or 'white box ML' to identify how CPPs affect the product yield and quality mechanistically, thus enabling rational design and control of the bioprocess. In this review, we describe the role of statistical modeling in Quality by Design (QbD) for biomanufacturing, and provide a generic outline on how relevant ML can be used to meaningfully analyze bioprocessing datasets. We then offer our perspectives on how relevant use of ML can accelerate the implementation of systematic QbD within the biopharma 4.0 paradigm.

SUBMITTER: Walsh I

PROVIDER: S-EPMC8744891 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFurther improvements in population health in low- and middle-income countries demand high-quality care to address an increasingly complex burden of disease. Health facility surveys provide an important but costly source of information on readiness to provide care. To improve the efficiency of health system measurement, we applied unsupervised machine learning methods to assess the performance of the service readiness index (SRI) defined by the World Health Organization and compared it to empirically derived indices.MethodsWe drew data from nationally representative Service Provision Assessment surveys conducted in 10 countries between 2007 and 2015. We extracted 649 items in domains such as infrastructure, medication, and management to calculate an index using all available information and classified facilities into quintiles. We compared three approaches against the full item set: the SRI, a new index based on sequential backward selection, and an enriched SRI that added empirically selected items to the SRI. We evaluated index performance with a cross-validated kappa statistic comparing classification using the candidate index against the 649-item index.Results9238 facilities were assessed. The 49-item SRI performed poorly against the index using all 649 items, with a kappa value of 0.35. New empirically derived indices with 50 and 100 items captured much more information, with cross-validated kappa statistics of 0.71 and 0.80, respectively. Items varied across the indices and in sensitivity analyses. A 100-item enriched SRI reliably captured the information from the full index: 83% of the facilities were classified into correct quintiles of service readiness based on the full index.ConclusionA facility readiness measure developed by global health experts performed poorly in capturing the totality of readiness information collected during facility surveys. Using a machine learning approach with sequential selection and cross-validation to identify the most informative items dramatically improved performance. Such approaches can make assessment of health facility readiness more efficient. Further improvements in measurement will require identification of external criteria-such as patient outcomes-to guide and validate measure development.

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Harnessing the potential of machine learning for advancing "Quality by Design" in biomanufacturing.

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