GMP AAV Vectors Production

Viral vectors have a long track record in therapeutic gene delivery and intervention. Current efforts are starting to bear fruit, as more viral vector therapies are reaching the later stages of clinical development. Since the discovery of adeno-associated virus (AAV), a variety of serotypes and variants have been described and characterized, with AAV2 being the most widely studied. The single-stranded DNA (ssDNA) genome, which is flanked by two inverted terminal repeats (ITRs), can be replaced by any gene (maximum z5kb) to create a rAAV vector genome. AAV vector technology has advantages that make it one of the most attractive solutions for therapeutic gene delivery. It is possible to transduce both dividing and nondividing cells with AAV vectors, and long-term transgene expression can be achieved in post-mitotic cells. Besides, AAV exhibits low immunogenicity, and no adverse events have been reported during past clinical trials.

AAV vectors are currently among the most commonly applied for in vivo gene therapy methods. The evaluation of vectors during clinical development requires the production of considerable amounts of highly pure and potent vectors. The scale of production is mainly determined by the number of virus particles required per batch. For adenovirus production, a scale associated with the cultivation of up to 1015 virus particles (VP)/batch or less may be normally produced in up to 100 L bioreactor for gene therapy applications. A process that allows the robust and reproducible manufacturing of a drug at the required scale, with the required yields and purity, is important for its clinical development and commercial viability.

A sample manufacturing process using AAV vectors.

Figure 1. A sample manufacturing process using AAV vectors.

For over a decade, QVirus™ Platform at Creative Biogene has developed a cell transfection and production system that is an efficient, scalable process for engineering cell function and enabling cell-based manufacturing for clinical applications. QVirus™ Platform has developed 293T and HEK293 producer cell lines for both adherent and suspension culture GMP AAV production methods. Besides, we will guide your selection of cell line and culture condition based on the size of your transgene, the serotype of your AAV gene therapy, and the quantity of GMP AAV required.

Service Highlights

➢ Seamless process transfer from development to GMP partner
➢ Established manufacturing process for all common AAV serotypes
➢ Scale-up capabilities and high end 2 step purification
➢ Synchronized preclinic and GMP manufacturing processes and quality controls

QVirus™ Platform has the expertise to assist you with the GMP manufacture of AAV. If you have any special requirements, please feel free to contact us.

References
1. Merten O W, et al. Manufacturing of viral vectors for gene therapy: part I. Upstream processing. Pharmaceutical Bioprocessing, 2014, 2(2):183-203.
2. Blessing D, et al. Scalable Production of AAV Vectors in Orbitally Shaken HEK293 Cells. Molecular Therapy-Methods & Clinical Development, 2019, 13: 14-26.

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