Umetrics Suite Blog

Which data analytics methods best support a quality by design approach for biosimilars?

November 12, 2019

Biosimilars are an exciting route to increasing access to the highly effective therapy made possible by biologics, but ensuring a biosimilar meets the critical quality attributes (CQA) of the original biologic is a major challenge. Optimizing production at full scale is impractical, which makes a quality by design (QbD) approach using a reliable scale down model of the process an attractive alternative. A process development team at Zhejiang Hisun Pharmaceuticals, Taizhou, China, therefore developed a scaled down model of the cell culture process used to produce the biosimilar adalimumab. They qualified the model using multivariate data analysis (SIMCA), and explored the design space for key process attributes (KPA) and CQAs using MODDE.

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Streamline your biopharma development with integration between Genedata and MODDE® DOE software

May 2, 2019

One key to reducing R&D costs in the biopharmaceutical market is streamlining and speeding up process data flow for Design of Experiments (DOE). Now, a direct integration of Genedata Bioprocess® platform and Umetrics Suite MODDE® software enables seamless data flow and facilitates the design, execution and evaluation of experiments in large-molecule process development.

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Design of Experiments enables the optimization of transfection efficiency in line with QbD principles

November 29, 2018

Pressure to cut development costs and lower regulatory barriers while assuring product quality has stimulated the pharmaceutical industry to apply Quality by Design (QbD) to manage risk and gain process and product understanding. As a result, QbD is being widely promoted by regulatory authorities such as the Food and Drug Administration, and the International Conference on Harmonization.

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How to ensure data integrity and compliance of your data analytics systems

October 31, 2018

Making sure your data and processes from research and development through to production are compliant is essential in today's highly regulated life science, biopharma, pharmaceutical and food industries. But it's no easy task. Following all of the required steps and ensuring the integrity of your data at every stage is easier and more successful when you use a product designed to keep your data compliant.

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Creating a design of experiments study to predict formula robustness

November 9, 2017

Using a Quality by Design (QbD) approach for DOE supports ICH Q8 compliance

In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.

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