Insights On Enterprise Solutions
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Scaling Up Your Viral Vector Therapy
7/7/2020
Early in the development of viral vector gene therapies, it’s critical to design a strategy that supports commercial needs based on clinical indication, patient population size and dosing requirements. This video reveals the most important factors to consider when scaling up.
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Risk Mitigation For Single-Use Cold Chain Distribution
7/7/2020
In this recorded webinar, we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.
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Bridging The Connectivity Gap Between Traditional Sensors And Single-Use Systems
6/30/2020
The secure, leak-free connection of sensors to single-use assemblies is paramount in ensuring both the accuracy of the measurements taken and protection of the manufacture of expensive drug products.
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Establishing Process Data Visibility In Contract Manufacturing Networks
6/30/2020
This joint webinar with Accenture explores the key findings from Accenture’s ‘Dare to be Different’ industry survey including the challenges within today’s increasingly decentralized and complex supply chain and how sponsors and CDMOs plan to address them.
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What To Expect From Your First CMO Remote Audit
6/26/2020
Choosing the right manufacturing partner means going beyond just technical specs. Having the opportunity to see facility layouts and condition are critical. However, with COVID-19 changing how we think about travel, will the in-person audit become a thing of the past? GMP does not require on-site audits and the benefits offered by touring online could spell the end of CMO facility visits for good. Now is the time to begin familiarizing yourself with the remote audit process.
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Business And Legal Risks In Life Science Outsourcing
6/26/2020
Significant business and legal risks threaten emerging and global life science enterprises. Among those are the industry's extensive reliance on external partners for product development and CDMOs.
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Ensure Sterility In End-To-End Bulk Management
6/22/2020
A CMO was experiencing sporadic product loss through cross contamination. To mitigate risks for further losses through contamination, the innovative CMO was looking for a reliable approach to guarantee sterility in their processes from downstream to fill & finish by all means.
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Strategies For Flexible Manufacturing
6/22/2020
Biopharmaceuticals are increasingly complex and on shorter timelines to meet patient needs. Here's an in-depth look at the latest market drivers, approaches, and technologies in flexible manufacturing.
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R&D Quality As The Foundation For Product Quality
6/22/2020
This webinar will focus on current practices in use at Cytovance Biologics as part of product lifecycle management. At times, projects are received with differing amounts of background information and this webinar will discuss control of quality during the various stages of R&D while still maintaining the flexibility necessary for research. There must be dynamic balancing of expectations for quality with the needs of the scientists to understand and characterize the material being produced particularly in R&D.
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Phase-Appropriate GMPs: A Regulatory Roadmap
6/22/2020
This webinar will focus on current best practices for mapping the regulatory framework during R&D, investigational phases, and to commercial manufacturing. Taking a proactive approach to exploring what control strategies are expected, and subsequently required, will provide a streamlined development approach ensuring the safety and quality of the product.