May 2020 Featured Report

Challenges and Benefits of Networking Process Control Manufacturing Systems: Integration to Business Systems in Industry 4.0

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Networking of manufacturing process control systems can lead to benefits of efficiency, increased productivity, and better facility use, leading to lower cost of goods (CoG). Furthermore, integration of manufacturing systems with manufacturing execution systems (MESs) upward to an enterprise resource planning (ERP) business system improves overall organizational efficiency. An ERP system enables optimization of intrafacility manufacturing resources. For multiple manufacturing facilities, it facilitates optimization across a company’s manufacturing network. Enabling Technologies and Systems At the enterprise resource planning level (Figure…

May 28, 2020

Designing the Right Strategy for Digital Transformation: How a Pragmatic Approach to Digital Transformation Can Help Biomanufacturers Adapt to a Challenging Future

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Although the biopharmaceutical industry has enjoyed explosive growth over the past three decades, it still faces an assortment of challenges. Those include growing portfolio complexities, increased demand volatility, stringent regulatory requirements, increased pricing pressures, and growing technological complexities, all leading to severe pressure on profit margins. To overcome such pressures, biopharmaceutical operations need to become more reliable and agile, and they must realize efficiency gains in both manufacturing and supply chains. Digital transformation offers strong value opportunities, including a potential…

May 28, 2020

Fluorescent Nanosensors: Real-Time Biochemical Measurement for Cell and Gene Therapies

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Cell and gene therapies are destined to transform the methods by which global healthcare challenges are approached and overcome (1). The US Food and Drug Administration is reviewing and approving an increasing number of cell and gene therapy products (2), and biopharmaceutical developers are dedicating immense resources to realizing the enormous potential of these therapeutics. Therefore, technologies that facilitate their effective and efficient manufacture will accelerate cell and gene therapies’ transition from medicines of the future to medicines of the…

May 28, 2020

Soft Sensors for Bioprocess Monitoring

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Achieving the high process efficiencies and optimization of Manufacturing 4.0 will require sophisticated software systems, mathematical modeling, and on-line process monitoring. Soft sensors are valuable tools that enable users to measure process parameters in real time. I spoke with Benjamin Bayer, data scientist at Novasign GmbH and doctoral candidate at the University of Natural Resources and Life Sciences in Vienna, Austria, about the potential of soft sensors for bioprocessing and important considerations for their use. Introduction How would you describe…

May 28, 2020

Developing Process Control Strategies for Continuous Bioprocesses

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Process control enables biomanufacturers to ensure that operating parameters are within defined specifications. A control strategy should be established during early stages of process development while process and product performance are being defined using risk-based methods such as quality by design (QbD) and process analytical technologies (PATs). Confirming process control as an essential part of product development creates greater process knowledge and understanding and provides the first steps toward process optimization. By understanding how process performance relates to product quality,…

May 15, 2020