AAV Testing Service

Recombinant adeno-associated viral (rAAV) vectors have been used in over 200 clinical trials with a good safety profile and significant clinical benefit in a number of genetic diseases. Moreover, because of their ability to infect non-dividing and dividing cells and to act as an efficient substrate for homologous recombination, rAAVs are being used as a tool for gene-editing approaches. Nevertheless, manufacturing of these vectors at high quantities and fulfilling current good manufacturing practices (GMP) is still a challenge, and several technological platforms are competing for this niche. The most commonly found impurities in rAAV stocks include defective particles (AAV capsids that do contain the therapeutic gene or are not infectious), residual proteins from host cells and helper viruses (herpes simplex virus, adenovirus, or baculoviruses), and illegitimate DNA from cells, plasmids, or helper viruses that may be encapsidated into rAAV particles. Furthermore, rAAV particles contain all of the AAV genetic elements required for their propagation in the presence of a helper virus, whereas pseudo-wtAAV particles harbor only a portion of the wild-type genome. Although AAV is considered as nonpathogenic, these types of particles are undesirable, in particular because Rep proteins may induce nicks in DNA, and cap expression could trigger the immune response.

From master cell bank creation through lot release, QVirus™ Platform provides clients with a comprehensive portfolio of GMP, GLP and USP testing services to support your pipeline's AAV-based programs. With decades of virology experience, a team of expert scientists, and continual investment in equipment and facilities, QVirus™ Platform delivers a testing platform that saves clients time and money.

Our Testing Services for AAV-Based Products Purity and Safety

Safety TestMethod
endotoxinLAL assay
Rabbit pyrogen assays
sterility/bacterio- and fungi-static activitySterility tests
replication-competent AAVSerial infection on permissive cells/rep or cap qPCR
Purity TestMethod
General puritySDS-PAGE/silver staining
ProteinSDS-PAGE/Coomassie blue
HPLC
Residual BSAELISA
Residual production reagentHPLC, MS, ELISA
Host cell proteinsMS, ELISA
Residual cell DNAqPCR, HTS
Residual DNA from raw materialqPCR, HTS
Empty/intermediate particles
Ratio vg (qPCR)/vp (ELISA)
Electron microscopy, AUC

* LAL, limulus amebocyte lysate; qPCR, quantitative real-time PCR; HPLC, high-performance liquid chromatography; ELISA, enzyme-linked immunosorbent assay; MS, mass spectrometry; HTS, high-throughput sequencing; AUC, analytical ultracentrifugation;

Our AAV testing program also includes:

  • Established assays to quantitate genomic/vector copy numbers which utilize common sequences covering a wide variety of AAV serotypes.
  • Genome titer assay available by qPCR or ddPCR.
  • Experience with cell-based potency assays for AAV and other viral vectors.

With years of experience in biosafety assessment, Our QVirus™ Platform can design a customized testing program to assess the purity, potency, and safety of your viral vaccine or gene therapy product at phase-appropriate levels to support your regulatory filing. If you have any special requirements, please feel free to contact us.

References
1. Penaud-Budloo M, et al. Pharmacology of recombinant adeno-associated virus production. Molecular Therapy - Methods & Clinical Development, 2018:S2329050118300032.
2. Werling N J, et al. Systematic Comparison and Validation of qPCR Methods for the Quantitation of AAV Products. Human Gene Therapy Methods, 2015, 26(3):82.

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