01.26.23 -- FDA's Final Guidance On Early-Phase CGT Trials

The Hofmeister Series applies to upstream media – for bioavailability and foam stability, downstream buffers – for purification and to the formulation and final fill drug product stability.

With smartphones now ubiquitous, read about how interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage.

Identify and examine the key trends in the advanced therapy medicinal product (ATMP) industry and explore their impact on companies across a range of concerns, including speed to market, efficiency, safety, and innovation.

This study shares how a detection system can be trained to identify infected cells, and then be used to determine the percentage of infected cells within the culture in real time.

The Cooperativity Program’s goal is to help ISG clients build and strengthen their in-house departments — medical writing or otherwise — to reach their utmost potential.

Explore how technological advancements, innovative business models, increased wearables support, FDA’s push to the industry to adopt DCT, and a holistic approach to clinical trials have proliferated the DCT landscape.

The performance of the VIA Thaw CB1000 is compared to thawing in a water bath. The VIA Thaw™ dry thawing system shows comparable performance to a water bath but with less handling.

Managing the manufacturing process for cell and gene therapy products can be a significant challenge. Delays can affect capacity, resource planning, and the path to product commercialization.

Will Junker, head of manufacturing quality at Kite Pharma, talks to Cell & Gene: The Podcast listeners about the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time to market. We also discuss why developing a better understanding of the vector manufacturing process is critical to bringing continuous and secure supply to market. 

Learn from an analytical scientist about the demand for efficiency in bioprocess workflows that is driving a need for greater improvements in analytical assay performance and instrument automation.

The successful outcomes delivered by cell and gene therapies, coupled with the emergence of modalities across nucleic acid therapeutics and microbiomes, pose the next scalability challenge.

In this webinar, explore how to accelerate CGT workflows using highly sensitive single-cell DNA sequencing (scDNA-seq).

Discover key upstream and downstream considerations for process development for RNA drug substance manufacturing and the parameters that need construct-specific optimization to increase yield and reduce impurities.