The use of Stable Producer HEK293 Cell lines for Viral Vector Manufacturing
Gene and cell therapy workflows frequently utilise stable producer HEK293/293T cells in the production of viral vectors and are an example of an advanced therapy medicinal products (ATMPs). Compared to transient transfection methodologies, stable producer lines can provide a more scalable, higher titer production method, provide improved batch-to-batch consistency and also be a source for “the material for sequencing” as described in FDA draft guidelines from 2018.
Seeding and Evidence of Clonality with HEK293 Cells
The 2020 FDA guidance on CMC and INDs for cell and gene therapy spoke to both regulators and manufacturers looking to standardize best practices around viral vector production workflows. This includes avoiding the use of animal-derived reagents and using assurance of clonality as part of production quality control was highlighted.
Contemporary Viral Vector Workflows
Several gene and cell therapy treatments for rare and monogenic diseases and cancer are moving into late-phase clinical trials and commercial production.
These advances have led to more regulatory oversight on the manufacturing processes to produce viral vectors used for these treatments.
Regulatory expectations for gene therapy are discussed in this paper in the light of the latest FDA Guidance to Industry (Jan 2020).
Delivering Assurance For Viral Vector Production
Unparalleled regulatory assurance - The clonality report automatically captures the evidence of clonality, from single-cell to colony, within the context of a whole well image.
Faster project delivery - GSK report InstiGRO HEK had a significant positive effect on clonal outgrowth in all conditions tested, with increase in outgrowth ranging from a factor of 2.7 to 11.5
Proven technologies - For over 10 years, we’ve developed and sold technology to the leading biopharma companies worldwide, validated and backed by ISO 9001.
Fast customer site implementation - Most customers achieve full technology implementation within two-three months of installation.
Simple operation - Our instruments are designed for effective use by all team members, enabling workflows to be replicated across multiple sites.
Quality service - Our robust instruments and reagent products are supported at a global level.
Technologies for Viral Vector Production
VIPS for high efficiency single cell seeding and in-well verification by imaging
Very low-pressure seeding with high-efficiency plating leads to confidence in clonally-derived outgrowth. Cell imaging of the VIPS droplet in the dry well gives evidence of successful single-cell isolation. More about VIPS>
Cell Metric for Day 0 single cell assurance and outgrowth imaging
Whole-well, high-contrast imaging of the media-filled well to confirm the presence of a single-cell at day 0. Daily imaging to follow outgrowth with data wrapped up in clonality report for confident IND submission. More about Cell Metric>
Animal-free InstiGRO™ and InstiSHAKE™ Cell Growth Supplements for HEK Cells
InstiGRO HEK for higher chance of single cell recovery and faster, high-efficiency clonal outgrowth for compressed workflows. InstiSHAKE for increased growth rates and viability when expanding from static to fed-batch shaking culture.
InstiTHAW™ HEK to protect cells during freezing and thawing.
InstiTHAW HEK is designed to aid successful cold storage of HEK cells for enhanced cell recovery.
The true potential of gene therapy – with the incredible promise to treat a vast variety of diseases – will only be realised through enhanced manufacturing practices. In a recent article published in Genetic Engineering and Biotechnology News, the technologies, approaches and tools needed to standardize viral vector production and ensure the pipeline meets GMP standards are discussed. In the article, six developers – including Solentim – are showcased, along with their tools and solutions working to streamline production and make viral vector treatments more accessible to patients around the world.
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