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Recombinant adeno-associated virus (rAAV) has become one of the most attractive viral vectors for many gene therapy applications, because of its efficient transduction ability to both dividing and non-dividing cells, long-term gene expression in vivo, lack of human pathogenicity and minimal immunogenicity.
Figure 1. Distribution of adeno-associated virus (AAV)-mediated gene therapy in clinical trials. Each panel represents number of clinical trials by (A) current status of the clinical phase, (B) therapeutic area, and (C) gene therapy approaches. BD, Blood disorders; CNS, Central Nervous System; ED, Eye Disorders; LSD, Lysosomal storage disorders; NMD, Neuromuscular Disorders. (Au HKE, Isalan M, Mielcarek M. Gene Therapy Advances: A Meta-Analysis of AAV Usage in Clinical Settings. Front Med (Lausanne). 2022 Feb 9;8:809118.)
However, the large-scale production is a major challenge for the use of rAAVs in gene therapy applications. In order to make sure that our services can meet diverse needs from our clients, Creative Biogene has established platforms suitable for three-grade of AAV manufacturing that cover non-GMP AAV manufacturing, GMP-Like AAV manufacturing and cGMP AAV manufacturing. Our AAV manufacturing platforms enable robust and economical rAAV production suitable for different downstream applications including drug discovery research, pre-clinical studies, and clinical trials.
2) GMP-Like/GLP AAV Manufacturing
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