AAV Gene therapy manufacturers must meet regulatory requirements across their manufacturing process to ensure patient safety. This includes all starting materials, excipients and ancillary materials used to create the therapeutic AAV particle, because they can have an effect on the final product.

Transfection reagents are ancillary materials, which are used during the manufacturing but are not intended to be present in the final drug product.

AAV manufacturers expect their raw material suppliers to comply with regulatory agencies by upholding to the highest quality standards and aligning with CMC guidelines.

At Polyplus, we do not compromise on quality or performance. FectoVIR®-AAV GMP is a premium transfection reagent that ensures:

• Patient safety. FectoVIR®-AAV GMP manufacturing strictly follows the ICH Q7 & Part II GMP guidelines. It is manufactured in compliance with the most stringent guidelines for the use of raw material (Eudralex Vol 4 Part II, Annex 1).
• Robust & reliable aseptic manufacturing. FectoVIR®-AAV GMP is produced following a robust and aseptic manufacturing process to guarantee quality of each batch and ensure batch to batch consistency.
• Manufacturing cost-effectiveness. FectoVIR®-AAV GMP is the scaled duplicate of FectoVIR-AAV to guarantee similar AAV production yield during process development for large scale GMP manufacturing and commercialization.
• Accelerated time to market. FectoVIR®-AAV GMP is intended to increase transfection performance and industrial scalability to expand the number of doses per production batch to treat more patients.