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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

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.

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Understanding Large Molecule Drug Development: From Biologics to Market

Impact Pharmaceutical Services

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.

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Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

The FDA Law Blog

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.

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Personalised culture media solutions support timely biopharmaceutical manufacturing

European Pharmaceutical Review

They need to resolve any issues that affect cell performance and quality, whether it is media optimisation or process improvement. Our R&D team is happy to present custom media development and manufacturing options for our clients to consider, to meet these challenges.

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Drug development trends: insight from Thermo Fisher’s Anil Kane

European Pharmaceutical Review

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 process improvements, and to bring efficiencies in process. Also, we can expect to see the utilisation of digital technologies for predictive modelling.

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Top 4 Reasons an In-House Fuld + Company Consultant Boosts Companies’ Strategy + Intelligence Capabilities

Fuld

We often deploy our Intelligence Benchmarking Survey as a barometer for process improvement 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

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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.,”