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rAAV (Adeno-Associated Virus) manufacturing using HEK-293 derivative cells
|Number of transfections|
1 L of FectoVIR®-AAV transfection reagent is sufficient to transfect on average 500 L of cell culture (using standard conditions)
Store FectoVIR®-AAV at 5 °C ± 3°C.
|Regulatory documentation (FectoVIR®-AAV GMP only)|
Certificate of compliance
FectoVIR®-AAV is a novel generation of synthetic transfection reagent specifically developed for industrial scale production of recombinant AAV (rAAV) in both suspension and adherent HEK-293 derivative cell systems. FectoVIR®-AAV transfection reagent guarantees higher rAAV titers, improves scalability for large scale production and de-risks manufacturing process with it’s availability at pharma GMP grade. FectoVIR®-AAV-GMP is manufactured under a validated and aseptic process in compliance with ICH Q7, GMP part II guidelines, the quality grade of reference for active pharmaceutical ingredients (API).
|Reference Number||Product||Amount of reagent|
|101000044||FectoVIR®-AAV||FectoVIR®-AAV 1 mL|
|101000022||FectoVIR®-AAV||FectoVIR®-AAV 10 mL|
|101000004||FectoVIR®-AAV||FectoVIR®-AAV 100 mL|
|101000054||FectoVIR®-AAV||FectoVIR®-AAV 1 L|
|102000006||FectoVIR®-AAV GMP||FectoVIR®-AAV GMP 100 mL Bottle|
|102000009||FectoVIR®-AAV GMP||FectoVIR®-AAV GMP 1 L Bag|
|120-001||***NODISPLAY***||***NO DISPLAY*** 1 ml||***NODISPLAY***|
|120-01L||***NODISPLAY***||***NO DISPLAY*** 1L||***NODISPLAY***|
|120-010||***NODISPLAY***||***NO DISPLAY*** 10 ml||***NODISPLAY***|
|120-100||***NODISPLAY***||***NO DISPLAY*** 100 ml||***NODISPLAY***|
Superior AAV yields to increase the number of doses per production batch
Titer value is the critical measurement to evaluate cost reduction. The choice of the transfection reagent has a direct impact on manufacturing costs. In comparison to gold standard PEIpro® and other competitor transfection reagents, FectoVIR®-AAV stands out with its unmatched performance in producing highest rAAV yields in suspension cell culture systems. FectoVIR®-AAV reproducibly improves AAV production yield with up to a remarkable 10-fold increase in viral genome titer compared to other competitors.
Achieving process economics by process intensification to decrease manufacturing costs
The transfection reagent is a key raw material that can provide direct cost benefits. With its remarkable performance, FectoVIR®-AAV enables process intensification by increasing productivity. By producing more rAAV particles, a greater number of doses is achieved for a same batch volume, meaning a reduction in the cost per dose (less labor and raw materials) and a reduction in footprint (fewer or smaller bioreactors for lower capital expenses) to bring the total manufacturing cost down.
Industrial scalability with low complexation volume
Scalability is essential to guarantee the development of high-yielding and reliable rAAV viral vector manufacturing process for commercialization. Large scale transient transfection implies that large volumes of transfection complexes need to be prepared and added to suspension cells within a given time frame for the transfection to be efficient. FectoVIR®-AAV solves volume constraint. FectoVIR®-AAV has been optimized to reduce the complexation volume down to 1%, facilitating the preparation of transfection complexes for large scale manufacturing. For example, for a 2000 L cell suspension volume, the transfection complexation volume can be optimized down from 200 L (10%) to 20 L (1%).
Industrial scalability with longer complex stability
Large scale transient transfection requires addition of a larger volume of transfection complexes to suspension cell culture, which means longer transfer time. With FectoVIR®-AAV, the transfer time is no longer a limiting factor that can lead to viral titer yield variability. FectoVIR®-AAV transfection complexes show tremendous stability: upon mixing FectoVIR®-AAV transfection reagent and plasmid DNA, transfection complexes can be reliably added to cells within 3h with no significant variation in rAAV titer yields.
Ensuring patient safety: cGMP grade transfection reagent to derisk AAV manufacturing
FectoVIR®-AAV GMP is produced in a two-step process in compliance with ICH Q7 GMP Part II (Eudralex Vol 4, Part II) ensuring validated and aseptic manufacturing process to maximize the transfection reagent quality. FectoVIR®-AAV 1 L bag allows to work in closed system with MPC connection and weldable c-flex tubing to decrease contamination risks. Polyplus accompanies each customer with complementary regulatory support regulatory filings (IND and BLA) in addition of a full set of documentation to ensure traceability and quality of the product. A residual test, to analyze the transfection reagent present/absence in the drug product, is available through selected service providers.
Zoom on the importance of quality for viral vector manufacturing optimization
AAV Gene therapy manufacturers must meet regulatory requirements across their manufacturing process to ensure patient safety. Transfection reagents are ancillary materials, which are used during the manufacturing but are not intended to be present in the final drug product. Benefit from Polyplus’ regulatory expertise to
- Understand current CGMP practices for raw materials
- Improve risk mitigation
- Rely on QbD to enhance quality of manufacturing process
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