Newsletter | November 30, 2023

11.30.23 -- Accelerating Process And Analytical Development Timelines For Cell And Gene Therapies

Optimizing And Scaling Lentiviral Vector Production

Here, we outline how the upstream and downstream workflows of the VirusExpress® platform for lentiviral vectors (LVVs) were optimized through the use of design of experiments and supplementary studies to develop a scalable, robust, and streamlined approach for LVV manufacturing that addresses cell and gene therapy innovators' needs.

 

The Importance Of Scalability In Viral Vectors

Diseases that previously lacked cures or even treatments may be addressed with new classes of gene therapeutics. Often, viral vectors are challenging to produce at the large scales needed to reach the potential of these therapies. We dive deep into the importance of scalability in viral vectors with Eva Fong, senior scientist at MilliporeSigma.

 

Applying High Throughput Processes To Optimize AAV Titers

Recombinant adeno-associated virus (AAV) has emerged as a leading modality for in vivo gene therapy. Development teams have established an innovative approach to upstream optimization for these therapeutics, demonstrated via high-throughput methods for transfection optimization and scale-up of an optimized process to bench-scale bioreactors.

 

Process Development Is Key To Patient Success

Process development (PD) is a critical component of the commercialization of viral vector-based therapies. While some gene therapy developers may want to speed through this operation to meet deadlines, doing so can put product quality, safety, and efficiency at risk. Explore PD and key factors to consider on the path to commercialization.

 

Accelerate Development And De-Risk Gene Therapy Manufacturing

Working with an experienced process and analytical development (PAD) team to guide you in developing robust processes and analytical methods is instrumental to the success of your gene therapy. Join viral vector PAD experts as they showcase strategies for developing robust processes and analytics for efficient and de-risked manufacturing.