Newsletter | April 16, 2021

04.16.21 -- Cell & Gene Therapy Process Development Resources

 
Robust Process Development For cGMP Manufacturing Of Cell Therapies
 
By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. This article tackles how to approach process development with a manufacturing workflow mindset that will transition smoothly to cGMP manufacturing.
Cell Therapy Scale-Up Strategies For Commercial Success
 
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.
Pluripotent Stem Cell Expansion And Scale-Up
 
Upstream process development is complex for stem cell therapies because these therapies involve many manipulations during cell differentiation, or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.
Platform Cell And Gene Therapy Media Development
 

As the industry moves into biologics, engineered cells, and viral vectors, and, ultimately, to a future where we're manufacturing restorative or regenerative therapies in their entirety, there is a tradeoff between the simplicity of the process and its cost-effectiveness. Here we describe the process of removing serum from the expansion step of an autologous cell therapy. The challenge is doing so in a cost-effective manner without affecting cell performance.

Practical Tips To Develop A Lentivirus Packaging Cell Line
 

Lentiviral vector (LV) production represents a large portion of costs for CAR-T therapies. At the Centre for Advanced Therapeutic Cell Technologies (CATCT) scientists are working to address obstacles that hinder commercialization of cell therapies. One project is aimed at reducing LV production costs. Here are practical tips and a case study to develop a lentivirus packaging cell line.

Improving Lentiviral Vector Downstream Processing Workflows
 

Lentiviral vectors (LV) are a common vehicle to deliver genetic material in CAR T-cell and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. This article discusses the process development pain points of a modern workflow and ways to address them.

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