Umetrics Suite Blog

Why DOE Is Essential in the (Bio)Pharma Industry

October 14, 2020

For pharmaceutical and biopharma companies, building quality into your products from an early stage is a key factor in regulatory approval and market success. Design of Experiments (DOE) is an essential tool for achieving both regulatory compliance and faster time to market.

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How Is DOE Used In Process Industries?

September 15, 2020

When it comes to creating an optimal manufacturing process that limits variation and conserves energy or resources, or a developing a new formula that is most likely to meet customer expectations, design of experiments (DOE) is an indispensable tool.

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Using Multivariate Models in a Regulated Environment for Continuous Manufacturing of Pharmaceuticals

January 14, 2020

Continuous manufacturing is one of the key trends within the pharmaceutical industry, both for the production of ‘classical’ drugs as well as large molecules. Companies are looking for ways to shift from traditional batch processing to a continuous method of operation. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, as well as more consistent quality of the drug product.

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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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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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