Development and Implementation of Process Analytical Technology (PAT) Systems in the Biopharmaceutical Sector – Challenges and Returns

Posted on August 15, 2017

Abstract The Food and Drug Administration’s (FDA) process analytical technology (PAT) initiative encourages pharmaceutical manufacturers to use innovative analytical tools to improve the understanding and control of their manufacturing processes. In-line and on-line process analytics constitute a vital element of the PAT strategy. The utilization of PAT tools to monitor media composition and control specific […]

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Single Use Systems in Biologics Manufacturing and their Impact on Manufacturing Execution System (MES)

Posted on July 27, 2017

Since their inception in production, single use systems (SUS) have evolved and improved thanks to the continuous relationship between vendors and biopharmaceutical manufacturers, accommodating a wide range of operational needs. From culture initiation in small volume bags, to large-scale production bioreactors, chemical solution preparation and product storage, the implementation of single use technologies is a […]

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Continuous processing optimization with smarter tools

Posted on June 30, 2017

  Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative ways to quickly and […]

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The future of biomanufacturing

Posted on June 29, 2017

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exists a lag in automation and measurement to make the most use of the technology and data integration. Next challenges in biomanufacturing The next set […]

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Process Analytical Technology for Upstream Bioprocessing

Posted on June 16, 2017

Summary In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence […]

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Implementing global best practices and technology specifications for single-use systems

Posted on April 12, 2017

How does your global company share internal expertise, best practices and specifications? Do you have platform technologies globally? Is it easy to find out what has been learned at other manufacturing sites? If not, opportunities exist for speed to market, elimination of redundant work, and cost savings. By: Jason Nisler Bioprocessing Application Specialist, CPC – […]

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Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

Posted on April 11, 2017

Summary Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a […]

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FDA’s Office of Pharmaceutical Quality Establishes the Center for Excellence in Manufacturing Science and Innovation Research

Posted on March 28, 2017

In January 2015, the FDA’s Office of Pharmaceutical Quality (OPQ) was stood up as a super office within the Center for Drug Evaluation and Research (CDER). Since then, OPQ has established itself as a global leader in regulatory science and research pertaining to drug product quality. A critical part of CDER’s mission is to ensure […]

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Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Posted on March 17, 2017

Summary Single-pass tangential flow filtration (SPTFF) followed by multi-column chromatography (MCC) was used to continuously process a cell culture supernatant containing a monoclonal antibody (MAb) via Protein A affinity chromatography. This study demonstrates the benefit of such a combination in term of process robustness, productivity and economics of continuous processing. The SPTFF technique can readily […]

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Challenges in the Development of Continuous Processes for Vaccines

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Abstract The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity […]

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