Information Technology

Multivariate Data-Driven Modeling for Continued Process Verification

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Continued process verification (CPV) is an integral part of process validation for the manufacture of human and animal drugs and biological products (1). It is designed to meet three primary goals: maintain a validated state of products, their processes, and related systems; enable continuous process improvements; and meet regulatory requirements for life-cycle validation. A CPV program for a biologic product entails regular collection of data related to critical process parameters (CPPs) and critical quality attributes (CQAs) and the preprocessing, analysis,…

October 28, 2021

Simplifying the Bioprocessing 4.0 Journey

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Bioprocessing 4.0, the biopharmaceutical version of Industry 4.0, is on course to become a reality in the next decade (1). This is because its “cyber-physical systems†that comprise cloud computing, connected systems, and digital process control offer many benefits. They include better process monitoring and management of a biologic’s critical quality attributes (CQAs) and the chance to control intensified processes for faster, less-expensive production of protein-based biologics and vaccines. Automation also can reduce the number of skilled operators needed while…

September 30, 2021

Prepared for the Future?
Smart Maintenance Is Key to Industry 4.0

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With the rapid advancement of digitalization, new technologies and flexible production concepts have become essential parts of the biopharmaceutical industry, especially for implementing Industry 4.0, the Internet of things (IoT), and predictive maintenance. As an expert partner for digitalization, Zeta supports its customers with new tools for smart maintenance. Swift commissioning helps biomanufacturers complete their projects successfully. That requires trained personnel and maintenance support. Intelligent tools based on digital plant data ensure smooth operation. Smart Maintenance Navigator (SMN) technology is…

August 27, 2021

The Promise of Artificial Intelligence in Healthcare

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The term artificial intelligence (AI) has become pervasive in conversations about the future of healthcare. AI has the potential to transform medicine through novel models of scientific discovery and healthcare delivery, ultimately leading to improved individual and public health. Yet misunderstanding and miscommunication abound. Thus, concepts related to AI need to be defined and explained to elevate our general level of understanding and our discourse around the topic. The Promise of AI in Healthcare AI has been studied by computer…

June 18, 2021

Preparing for Process Improvements: Discussions of the Cell Therapy Industry’s Supply Chain, Automation, and Control Needs

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As editors, we are fortunate to have the opportunity to listen to biopharmaceutical developers and innovators discuss the intricacies of their work. Typically, we find that the best discussions come from asking two fundamental questions: What need did you observe in the industry that drove your work, and what technologies would help you do your job better? Over the past five years or so, the answers have shifted. Cell and gene therapy (CGT) innovators are focusing on increasingly complex diseases…

April 26, 2021

Rapid Development of Viral Vector Production Processes: Iterative Parameter Optimization

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With recent developments and successes in cell and gene therapy, the biopharmaceutical industry is facing increased demand for safe and efficient delivery systems (1). Viral vectors, including adenoviruses (AV), adenoassociated viruses (AAV), and lentiviruses (LV), are among the most common delivery agents because they infect mammalian cells efficiently. Suspension cultures have become a popular choice for robust and scalable viral manufacturing systems. Using stable cell lines that integrate all or part of the viral production elements adds further benefits by…

April 16, 2021

Automation of Potency Assays: A Strategic Journey

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Cell-based potency testing provides quantitative data concerning a drug’s biological activity. Thus, it plays an essential role in biopharmaceutical quality control (QC), good manufacturing practice (GMP) product release, comparability determination, and stability testing for both drug products and drug substances. Potency is a critical quality attribute (CQA) often scrutinized by regulators and reviewers. Test methods are specific to a drug’s mechanism of action (MoA) and should be validated to internationally harmonized regulatory standards (1). The options preclude applying a simple…

March 9, 2021

Using Prior Knowledge to Estimate Long-Term Variation

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A reasonable estimate of long-term variation for a biopharmaceutical product critical quality attribute (CQA) can be challenging to justify, especially in the early stages of a product’s lifecycle when only limited data are available. However, if the combination of product and analytical method reasonably can be matched with historical data, prior knowledge can provide an estimate of a value. This variation estimate could be used to assist in risk assessments related to continued process verification (CPV) activities, including control charting…

March 9, 2021

Enhancing Vaccine Platforms: Computational Models Accelerate Development, Manufacturing, and Distribution

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Pandemics such as the current COVID-19 outbreak pose tremendous healthcare and economic challenges. Vaccines hold promise for controlling pandemics; however, substantial challenges come with pandemic-response vaccine development, manufacturing, distribution, and administration. To address those now, many companies are using rapid-response vaccine-production platform technologies. Computational modeling tools could help further accelerate development of those technologies, increase production and distribution efficiencies, and reduce costs and risks once vaccine platforms are fully developed and validated. To those ends, a set of modeling methodologies…

February 5, 2021

Practical Considerations for Statistical Analyses in Continued Process Verification

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Several statistical techniques can be used to assist in monitoring biopharmaceutical product quality attributes as part of continued process verification (CPV) activities. These include run charts, control charts, and capability analyses. Below, I provide an overview and recommendations on statistical strategies when developing a CPV program, considering the expected behavior of manufacturing results in the biopharmaceutical industry. Presence of Autocorrelated Data In a previous study, I highlighted the tendency for data to be positively autocorrelated (values are closely related to…

December 17, 2020