Umetrics Suite Blog

How CDMOs Can Use Data Analytics as a New Source of Revenue

November 20, 2020

The global biologics market is one of the fastest growing segments of the pharmaceutical industry. Annual revenues are expected to exceed $300 billion in the next 2-3 years.¹ But development and production can’t keep pace with discovery. That’s one reason outsourcing to contract development and manufacturing organizations (CDMOs) continues to increase. CDMOs, which currently represent 20% of the industry’s manufacturing capacity, are expected to grow to 30% of global manufacturing volume by 2025. ¹

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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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Using Data Analytics to Accelerate COVID-19 Vaccine Development

July 23, 2020

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.

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How to Make Sure You Have the Right Tools for Your Digital Transformation Process

June 25, 2020

Digital transformation in biopharma promises to deliver exponential results and make new discoveries and solutions to complex problems a reality, but it requires companies to make big changes to get there—changes in processes as well as adoption of new technologies. For some companies and facilities, this is a bigger leap than for others. Depending on the level of digitalization and integration that currently exists within a company, the process can take from months to years.

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Avoid Costly and Dangerous Process Deviations by Using Real-Time Data Analytics

March 5, 2020

Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes.

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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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How One Company Integrated Data to Implement Real-Time Bioprocess Monitoring

September 4, 2019

Most biopharma manufacturing companies are keen to adopt new methods that would streamline production, reduce errors and ensure product quality. That was the goal of Bristol-Myers Squibb when they implemented a complex real-time process monitoring system that involved integrating data from a number of different technologies, systems and vendors to gain greater control over complex batch processes.

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Data analytics techniques help researchers identify promising breast cancer biomarkers

March 12, 2019

Breast cancer is the most commonly diagnosed cancer amongst women worldwide and a leading cause of cancer related deaths among females. It’s the second most common type of cancer overall. According to the International Agency for Research on Cancer Research, there were more than 2 million new cases in 2018.

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Can data analytics improve biopharma manufacturing processes for autologous treatments like CAR-T?

December 13, 2018

Advancements in cell and gene therapy hold promise for the future of personalized medicine, especially for cancer treatments. However, bioprocessing methods for autologous cellular therapies, and CAR-T in particular, often present unique challenges in manufacturing due to the variability of the starting material and unique nature of each batch. Is there a way to create more efficient processes in order to bring down costs and make personalized medicine a viable option for more patients?

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Learn how one biopharma company relies on batch process MVDA to improve product consistency

September 20, 2018

In life science biopharma manufacturing, demonstrating consistent, repeatable processes is essential both for regulatory compliance and product quality. Being able to create data-driven, performance-based objectives, and aligning the process control strategies with compliance and business performance objectives, allows companies to take their data analysis to the next level: the level at which it becomes meaningful for the company’s bottom line.

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Use a spectroscopy tool to make spectral data analysis faster and easier

March 22, 2018

In pharmaceutical and other industries that rely on spectroscopy and multivariate calibration for quality control of manufacturing processes, optimizing the analysis of spectral data is imperative. Using a tool that is specifically designed with spectral analytics in mind can make the job faster, easier and more reliable.

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