Plasmid DNA and co-delivery of several plasmid DNA
GMP compliant Recombinant AAV virus production
Adeno-Associated Viruses (AAV)
Mammalian producer cell lines (HEK-293, HEK-293 derivatives) grown in suspension cultures
|Number of transfections|
100 mL of FectoVIR®-AAV transfection reagent is sufficient to transfect on average 50 L of cell culture
5 ± 3 °C, stable for at least 18 months from manufacturing date when stored appropriately
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.
|102000009||1 L Bag with weldable tubing and MPC connector|
Success of AAV commercialization relies on GMP compliant and industrial scalable production platforms to accelerate time to market and ensure patient safety.
FectoVIR®-AAV GMP ticks all the boxes to make each AAV-based gene therapy a success. FectoVIR®-AAV GMP ensures highest AAV titers with reproducible quality while ensuring maximum process robustness and process safety.
Performance at industrial scale
Building on our research use only (RUO) FectoVIR®-AAV composition, FectoVIR®-AAV GMP guarantees performance with a minimum two- to three-fold increase in AAV productivity in suspension HEK-293 cell systems, and industrial scalability of transfection. It can be used to produce therapeutic viral vectors for patient administration, from clinical trials through to commercialization, with marked increases in the volume of production and finished doses at a lower cost per dose. Read more on FectoVIR®-AAV, a giant step for AAV large scale manufacturing
Pharma GMP compliant manufacturing process
FectoVIR®-AAV-GMP is manufactured according to Pharma GMP guidelines. Pharma GMP guidelines are the most appropriate guidelines for raw materials, of which ancillary materials that transfection reagents belong to. These guidelines state that the quality of raw materials should be of pharmaceutical grade when available to avoid contamination and minimize variability of raw material (ICH Q7 and EudraLex Vol 4, Part IV, 7.13) in order to improve patient safety (Figure 1).
Fig 1. Manufacturing process of FectoVIR®-AAV GMP reagent.
Choosing pharmaceutical FectoVIR®-AAV GMP as transfection reagent ensures compliance with these guidelines. FectoVIR®-AAV GMP production is a two-step process, with the production of the intermediate powder product in compliance with ICH Q7 GMP Part II (Fig. 1) and the sterile filtration and aseptic fill & finish of the liquid final product (ready to use FectoVIR®-AAV GMP) in compliance with ICH Q7 GMP Part II / Eudralex Vol 4, Part II, Annex 1 (Table 1).
Table 1. FectoVIR®-AAV range characteristics