Thermo Fisher Expands Gene Therapy Portfolio to Support AAV Manufacturing

On July 7, 2021, Thermo Fisher Scientific announced its expanded gene therapy portfolio consisting of a new media panel, gene kit, and advanced purification resins to support adeno-associated viral (AAV) manufacturing. The tools aim to reduce manufacturing costs while increasing the viability of gene therapies as treatment options for patients.

The Gibco Viral Vector HEK Media Panel covers a broad variety of human embryonic kidney 293 (HEK293) cell types but is not tied to specific transfection reagents or techniques. The panel comprises ready-to-use formulations designed to help AAV developers identify an optimal formulation for their target cell line. The media included in the panel are optimized for higher titers, are scalable and customizable, and come with process consultation and data analysis to expedite media optimization and current good manufacturing practice (CGMP) manufacturing.

The Applied Biosystems resDNASEQ Quantitative Plasmid DNA–Kanamycin Resistance Gene Kit is easy to use and offers an all-in-one solution for precise and rapid measurement of residual plasmid DNA. The kit includes a highly sensitive multiplex quantitative polymerase chain reaction assay and contains all reagents. It also offers optimized sample prep options to help streamline workflows and 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 that are used in bioproduction for applications such as triple transfection of host cells to produce AAVs. According to Thermo Fisher in a company press release, 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 is the newest addition to the portfolio and includes POROS CaptureSelect AAV8, AAV9, and AAVX affinity purification resins as well as POROS CaptureSelect AAVX EvolveD Columns. These resins can significantly improve downstream processing of viral vectors by reducing purification steps. The resins also offer scalability to maximize process consistency, efficiency, and productivity, according to the press release.

"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, in the press release. "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."

Source: Thermo Fisher Scientific