Flexible manufacturing strategies for cell and gene therapy products

Mammalian cell line generation is a rate-limiting step in early CMC development and there is a constant desire to increase throughput. The implementation of automation is one way to increase throughput. This webinar will address some factors to consider during the process of automating a manual workflow including details of culture vessel changes, liquid handling adaptation, and changes of the cell line developer’s job during the process. With an end result of increased throughput, automation potentially allows cell line development to begin prior to final molecule selection. This can remove cell line development off the critical path of CMC development.

Virtual or “siteless” clinical trials allow trial coordinators and patients to conduct clinical study visits via online video calls and collect data via handheld or wearable devices. In addition, virtual trials increase the size and diversity of the patient pool, accelerate recruiting, and generate more informative, clinically-relevant data that is accepted by regulatory agencies. However, moving from traditional to virtual trials presents challenges as clinical trial sponsors learn how to design, execute, and complete effective virtual trials. To assure success, trial sponsors need to better understand the digital tools and platforms used in virtual trials, how to manage the data collection they enable, and the pitfalls to avoid. In this webinar, Bernard Munos, a pioneering pharmaceutical industry innovator, and Transparency Life Sciences co-founder Dr. Tomasz Sablinski will provide an overview of the strategies leaders are finding helpful in adopting and adapting to virtual trials.

Big datasets are a challenge to analyze. While all the “omics” crank out data by the terabyte, it hardly gets any bigger and messier than metagenomics data.

The genetic medicine revolution is truly underway. The COVID-19 pandemic has allowed mRNA and DNA-based vaccines to show their true potential, but the industry has ongoing challenges to overcome. Almost all of today’s genetic medicines (mRNA, DNA vaccines, viral vectors) are dependent on plasmid DNA as either a critical starting material or API, which presents challenges in advanced therapy manufacturing. Although plasmid DNA has proven its worth, enabling the production and availability of vaccines, there is also a bottleneck in the industry with contract manufacturers who offer GMP quality plasmid DNA, resulting in a substantial supply restriction. The inability to provide quality DNA within tight timelines is a threat to the rapid progress of R&D pipelines. Moreover, antibiotic resistance genes in plasmid DNA are becoming a crucial global issue and a topic of increasing regulatory scrutiny.