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PROCESS CONTROL YIELD ANALYSIS TRACK & TRACE PRODUCTION FACILITIES REPRODUCIBILITY SUPPLY CHAIN MANAGEMENT PROCESS AND PRODUCT R&D NOVEL APPLICATIONS HIGH TECH ENVIRONMENT QUALITY VOLUME INNOVATION

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In this webinar, you will learn: - The challenges tied to contamination control within a biopharmaceutical environment. - What closed processing is, and how sampling solutions are an integral component towards that end. - Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership. - Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling. Detailed description: Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection. Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.

Aseptic Process Sampling to address Risk of Contamination & Containment in co...

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Watch this webinar here: bit.ly/asepticwebinar2020 In this webinar, you will learn: - The challenges tied to contamination control within a biopharmaceutical environment. - What closed processing is, and how sampling solutions are an integral component towards that end. - Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership. - Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling. Detailed description: Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection. Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.

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Development of the PanDx Integrated Diagnostic Platform Wallace White Director, Point-of-Care Diagnostics Stratos Product Development UC Berkeley, March 5, 2015 After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it. Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI

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Watch this webinar here: https://bit.ly/2ZpV3GU Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics. Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle. In this webinar, you will learn: • Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite • Overview of Bioprocess lifecycle and present biomanufacturing data management challenges • Introduction to the Bio4C™ ProcessPad digital platform and its modules and features • Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations

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Watch this webinar here: https://bit.ly/2ZpV3GU Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics. Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle. In this webinar, you will learn: • Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite • Overview of Bioprocess lifecycle and present biomanufacturing data management challenges • Introduction to the Bio4C™ ProcessPad digital platform and its modules and features • Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations

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Nano Glass Structures

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8. PROCESS CONTROL YIELD ANALYSIS TRACK & TRACE PRODUCTION FACILITIES REPRODUCIBILITY SUPPLY CHAIN MANAGEMENT PROCESS AND PRODUCT R&D NOVEL APPLICATIONS HIGH TECH ENVIRONMENT QUALITY VOLUME INNOVATION