For gene therapy developers seeking to rapidly and efficiently scale production, a set of solutions is now available from Thermo Fisher Scientific to support adeno-associated viral (AAV) manufacturing. A new media panel, gene kit and advanced purification resins help reduce manufacturing costs while increasing the viability of gene therapies as treatment options for patients.
AAV is a non-pathogenic virus with the ability to infect cells at various stages of growth, and has become a preferred “viral vector” for delivering gene therapies. However, scalability of AAV remains a challenge, particularly during the purification process. New solutions designed to produce higher quality viral vectors simplify the purification process, resulting in higher yield AAV production.
“Despite the immense promise of gene therapy, robustness and yield continue to pose challenges in the manufacturing process,” said Betty Woo, vice president and general manager, cell and gene therapy at Thermo Fisher Scientific. “Growth media that maximizes viral titer and rapid analytical tests contribute to cost-effective and efficient AAV production. Our expanding gene therapy portfolio is designed for a smooth ramp-up to clinical production and we have made focused investments to ensure we stay ahead of commercial demand. Ultimately, our innovative solutions are developed to expedite the delivery of safer therapies to patients.”
The Gibco Viral Vector HEK Media Panel*, part of an expanding portfolio, covers a broad variety of HEK293 cell types and is not tied to specific transfection reagents or techniques. Its ready-to-use formulations will help AAV developers identify an optimal formulation for their target cell line. The media are optimized for higher titers, are scalable and customizable and come with process consultation and data analysis to expedite media optimization and cGMP manufacturing.
The easy-to-use Applied Biosystems resDNASEQ Quantitative Plasmid DNA - Kanamycin Resistance Gene Kit* offers an all-in-one solution for precise and rapid measurement of residual plasmid DNA. It includes a highly sensitive multiplex qPCR assay with all reagents and optimized sample prep options for a streamlined workflow that delivers results in under five hours. The kit targets conserved regions of multiple kanamycin resistance gene families, covering all common plasmids with kanamycin resistant genes used in bioproduction for applications such as triple transfection of host cells to produce AAVs. Residual plasmid DNA must be measured to demonstrate that it is below the thresholds set by regulatory agencies to ensure product quality and safety.
Thermo Scientific POROS CaptureSelect AAV affinity purification resins*, the newest in a portfolio of viral vector solutions that includes the leading POROS CaptureSelect AAV8, AAV9 and AAVX affinity purification resins and POROS CaptureSelect AAVX EvolveD Columns, can significantly improve downstream processing of viral vectors by reducing purification steps and offering scalability to maximize process consistency, efficiency and productivity. Standard purification processes require multiple chromatographic or centrifugation steps, which results in low yields and long process development timelines.
CaptureSelect ligand technology, combined with the large pore structure of the POROS beads, enables efficient purification of large biomolecules such as viral vectors. POROS CaptureSelect AAV affinity resins are superior for the purification of AAV vectors with respect to capacity and specificity, and the POROS CaptureSelect AAVX resin is truly pan-tropic, enabling purification of a broad range of AAV serotypes.
*Intended use of the products vary. For specific intended use statements please refer to the product label.
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