Newsletter | January 31, 2024

01.31.24 -- Is FDA's COVID Container Closure System Guidance Still Useful?

FEATURED EDITORIAL

Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic?

The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

When To Start Thinking About The Use Of Automation

In this segment, industry professionals discuss when teams should start thinking about automation in their operations and, more importantly, what key questions to ask when building a company’s automation framework.

INDUSTRY INSIGHTS

Transforming CGT With A Synergistic Partnership

Understand the strategic advantages of a new collaboration and discover how two companies' unified vision promises to elevate CGT to new heights, one empowered patient at a time. 

Access And Support For Cell And Gene Therapy

Experienced patient support hubs play a pivotal role in navigating the entire treatment journey, significantly reducing the time between treatment determination and therapy initiation for CGT patients.

Evaluating A Novel Cyclic Olefin Polymer Container System For Storing AAV

This study investigates the suitability of a container system composed of the novel COP CZ as an alternative for the ultra-cold storage of therapeutically relevant AAV viral vectors.

Plasmid Selection In Drug Discovery: Starting With The End In Mind

Clinical development milestones are built on the achievements of previous phases. Explore the importance of an effective strategy, working backward from the end goal: commercialization.

Reliable Osmolality Testing Of High-Concentration mAb Formulations

Review an evaluation of the OsmoTECH XT (freezing point) and Vapro 5600 (vapor pressure) osmometers as a means of measuring concentrated protein formulations.

Upstream Optimization Paves The Way For Full Capsids In AAV6

Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product.

Revolutionizing Healthcare Access With A Resilient Supply Chain Network

Delivering supplies and biospecimens to remote areas demands an experienced logistics partner. Learn how state-of-the-art technology streamlined the supply chain process for a remote clinical trial.

Setting Expectations For Post-Thaw Segment QC Testing On A CBU

Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution, in order to create a benchmark of what is to be expected when interpreting segment testing.

SOLUTIONS

UpTempo AAV Platform Process Cuts Development Timeline In Half

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