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Doctoral Capstone Presentations pbhamidi Thu, 08/22/2024 - 13:28 Blending Scientific Knowledge of the Human Body, Mind, Emotions and Spirit Doctoral Capstone Presentations Below are links to the brief presentations of doctoral capstone projects. Interested in working with an OTD capstone student or exploring the possibility?
Cooke, Research Associate Professor at the University of Maryland School of Pharmacy, Aaron Larson, VP of Health Plan Quality Analytics at UnitedHealth Group and Anita Pothen Skaria, Vice President of Quality and ProcessImprovement with Centene Corporation. Develop new performance measures for MTM quality.
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.
They need to resolve any issues that affect cell performance and quality, whether it is media optimisation or processimprovement. Our R&D team is happy to present custom media development and manufacturing options for our clients to consider, to meet these challenges.
The workshop included presentations by USP on its available standards for advanced therapies, FDA/CBER on CMC challenges for CART cell therapies, and industry approaches to potency testing during CART development, and using Analytical Quality by Design (AQbD) principles in potency assay development. Release testing alone is not sufficient.
Both processes are evolving to enhance product development and output. Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control.
We often deploy our Intelligence Benchmarking Survey as a barometer for processimprovement opportunities with many of our clients and over the years have found that nearly 60 percent of the organizations we’ve surveyed struggle with demonstrating and managing the perceived value of competitive and market intelligence initiatives. . <Read
For example, in selecting the best technology, we can obtain and use data-based analytics to design scale of tech transfer, to make scientific, data-based processimprovements, and to bring efficiencies in process. Also, we can expect to see the utilisation of digital technologies for predictive modelling.
[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
Combining the incremental processimprovements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. The recent expansion of global oligo manufacturing demand has presented numerous opportunities to design better molecules, better processes, and better facilities.
This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Accessed March 2023. drug supply.,”
Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles). Present in sufficient quantity to achieve target concentration in process and enable defoaming.
Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations.
In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous processimprovements for approved products. Then the durations were compiled for analysis and presented in the table. Table 1: Hypothetical example of how an assessment was performed.
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