Plasmid DNA products are one of the most common non-viral vectors, frequently used in both in vivo and ex vivo gene therapies. As a result, they can be utilised as drug substance (DS)/drug product (DP), intermediate or starting material.
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Today, cost pressure, market uncertainty, and market growth challenge the existing manufacturing technologies. With the rise of these more complex molecules often comes the challenge of manufacturing them cost-effective. One of the approaches that contract manufacturing organizations and drug development companies take to increase their manufacturing output is utilizing perfusion and process-intensive technologies. One of the challenges in such efforts is the adaptation of cells to very different culture conditions, which requires a sufficiently flexible cell and a good understanding of process requirements to maximize performance.
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Bio Pharma Asia
Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
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Workcast
Mike Keeney from Lawson Health Research Institute, Ontario, will present "Initial evaluation of the ClearLLab 10C System in the Immunophenotyping of Leukemia and Non Hodgkin Lymphoma". The presentation will introduce the new ClearLLab 10 Color System and the ClearLLab Control Cells, the first application-specific IVD control cells for leukemia and lymphoma* immunophenotyping as part of a validated system. He will then demonstrate the applicability of the system in evaluation of leukemia at Non-Hodgkin Lymphoma and will evaluate the results of the clinical accuracy study.
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