07.15.25 -- The FDA Was Darned Near Perfect, Right?

In a recent webinar, contract manufacturing experts explored innovations in viral vector manufacturing as well as addressing production challenges and quality control strategies.

Discover how an automated cryopreservation process is reshaping the leukapheresis supply chain and driving progress into the future.

Learn how a platform streamlines LVV titer measurement, offering a faster and more efficient alternative to traditional methods and addressing key process development challenges.

Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.

With real-world examples and a vision that challenges the prevailing norms of biotech commercialization, this conversation offers a powerful look at what it takes to reshape the future of healthcare.

Understanding these partnerships and their impact on efficiency and safety is essential for stakeholders navigating the complexities of CGT development and production.

This study compared non-viral transfection methods in primary human T-cells, demonstrating the feasibility of an LNP-based process with CRISPR/Cas9 and HDR template DNA in a single payload.

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Accelerate your path to the clinic with a cost-effective, label-free whole-body service — designed to deliver deeper insights, faster decisions, and better outcomes for your drug candidates.

These HEK293-derived, animal-component-free suspension cell lines form the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

Explore specificities and challenges, leveraging automation for scalability with the Cocoon^® Platform, building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.

Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

Examine how lipid nanoparticles revolutionize intracellular drug delivery to enhance RNA vaccines, cell therapies, protein replacement, and gene editing.

Here, we walk you through our groundbreaking, enzymatic DNA manufacturing process that enables the production of linear DNA templates for IVT mRNA synthesis — without the use of cells.

Cell therapies hold immense promise, but navigating the development process can be daunting. A strategic partner can bridge the gap between early-stage innovation and successful commercialization.