We power viral vector upstream process optimization

The development of robust, scalable, cost-effective processes that yield high titers of high-quality viral vectors is crucial to the successful commercialization of safe and efficacious gene therapies that require large and/or multiple doses to treat more prevalent diseases. The successful commercialization of viral vector-based therapies relies on GMP-compliant and scalable, industrialized production platforms to rapidly advance high-quality products to market while also ensuring patient safety. The most utilized approach to AAV (adeno-associated virus) and lentivirus (LV) production is through the transient transfection of mammalian cell lines, such as HEK293 or derivatives, followed by viral vector harvest, downstream purification processes and analytics for final product testing. Since viral vector production is a significant cost driver in AAV and LV-based gene therapies, it is prudent to optimize each step of the upstream manufacturing process already at the process development phase to ensure compliance of critical raw materials (eg. plasmid DNA, transfection reagents), maximize yield and product quality while minimizing costs.

 

Taking the right first-time approach to optimize end to end viral vector manufacturing process

 

  • Improve performance of your process by relying on innovative plasmid engineering and transfection reagents 
  • Improve cost-effectiveness of your manufacturing process through end-to-end scientific support for process scale-up and process intensification  
  • Reduce time to market with Polyplus’ end-to-end regulatory support to facilitate your regulatory journey to reach cGMP compliance 

Your journey starts here : roadmap for AAV manufacturing scale up

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Discover Our Applications

RNA/DNA Therapeutics

RNA/DNA in vivo delivery is the most powerful alternative to viral vectors for nucleic acid-based therapies. They offer substantial advantages in terms of reliability,safety and costs for nucleic-acid based therapies

Protein Production

Broad range of solutions is needed for manufacturing of functional  proteins or antibodies at the desired scale in bacteria, yeast and mammalian cell expression systems

Life Sciences

Optimised plasmid engineering and specific transfection reagents are key to enable protein expression in a wide range of adherent and suspension mammalian cell types