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.
In the midst of a global COVID-19 pandemic, a top priority for many pharma and biopharma companies is to get a vaccine developed, produced and delivered to the public as quickly as possible. Ushering a vaccine through rigorous testing protocols and regulatory approvals is not an easy (or quick) effort, but incorporating advanced data analytics could help accelerate the process. Data analytics has proven effective in speeding vaccine development both by enabling more efficient Design of Experiments (DOE) and by creating rapid-scale production rollout processes.
A new diagnostic method for detecting a rare kidney stone disease has recently been developed at the University of Iceland. Instead of using urine microscopy, which has certain disadvantages, the diagnostic method is based on mass spectrometry of plasma samples. Preliminary clinical data shows very promising results both in terms of detecting the disease and therapeutic drug monitoring. Design of Experiments (DOE) was used as a chemometric approach to optimize the assay. Below is a summary of the assay development and optimization.
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.
A challenge for the regenerative medicine industry is to develop cell culture processes that can be scaled up for high volume production. Finding a better way to scale up commonly used research cells like HEK293T (used for protein expression and the production of recombinant retroviruses or lentiviral vectors) would be beneficial for biologists in many fields of medicine. Dr. Franziska Bollmann, virus scientist at Sartorius Stedim Biotech in Germany, recently conducted two experiments to find out if micro bioreactor systems can help facilitate the transition from the traditional shake flask process to a more improved method optimizing process control.
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.
What’s the secret formula for creating long-lasting bubbles? Is expert knowledge of liquid dynamics needed to optimize the mixture design and develop the best bubble solution? Or can we use design of experiments (DOE) and data analytics to draw conclusions? Let’s a take a look at a fun example of how DOE can be used to optimize a mixture design in order to achieve our goal: create long-lasting bubbles.
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.
At the heart of any process used to manufacture biological products is a bioreactor setup that supports a stable and reproducible biologically active environment. The bioreactor provides a controlled environment to achieve optimal growth for the particular cell cultures being used.
In life science, biopharma and other areas of research, development and production, design of experiments (DOE) provides a systematic method to determine cause and effect relationships between factors and responses affecting a process, product or analytical system. But the key to understanding your results is effective analysis of your experimental data.
Worldwide demand for energy escalates every year, and the consumption of fossil fuels continues to increase despite the growing supply of alternative energy options. Globally, about 81 percent of energy comes from a finite supply of fossil fuels like oil, coal and natural gas. Fossil fuels are used to heat homes, run vehicles, power industry and manufacturing, and provide electricity.