We are happy to present a joint Vironova/Takeda study (PLoS ONE 17(6): e0269139) demonstrating a validated cryogenic TEM-based (cryoTEM) method to visualize, quantify, and assess the genome packaging in recombinant adeno-associated virus (rAAV) particles.
“This was a great collaboration, establishing how valuable cryoTEM is in gene therapy development”, says first author Mathieu Colomb-Delsuc, Lab Manager Research and Innovation at Vironova. “The full and empty rAAV capsid ratio in a sample correlates directly with the potency of a drug. This analysis method presents a reliable way to do that precise determination throughout the development process.”
The rAAV analysis method is validated according to ICH Q2 (R1). It is performed using Vironova’s proprietary GMP-compliant analysis software, VAS (which has lately been further enhanced to also detect intermediately filled particles).
We extend our appreciation and thanks to all Takeda co-authors for the fruitful cooperation.
Read the full paper on PLoS ONE
7 June, 2022
