Reference Materials

Reference Materials

Reference materials are controls or standards for quality control assays and methods. In the field of gene & cell therapy, reference materials are critical for comparability between studies and clinical trials. Previously, the only available AAV reference materials are provided by ATCC over a decade ago. As a leader in AAV production and analytical assays, Vigene is now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference materials are extensively analyzed with molecular based assays and transmission electron microscope.

Commercially supplied reference standards obtained from a reputable commercial source can be used in addition to certified reference standards, according to FDA gene therapy CMC guidance, released in January, 2020, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)”.

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AAV Reference Materials (Full Capsids)

Recombinant Adeno-associated virus (rAAV) is a widely used gene delivery tool for research and clinical applications. To be able to compare the pharmacokinetics and efficacy of rAAV, well-characterized AAV reference materials are needed for quality control assays and for bridging calibration of internal reference materials. The reference materials (full capsids) with accurate vector genome concentration can be used in qPCR-based vector genome quantification. Since AAV is known to produce empty particles without payloads, the full-to-empty ratio of standard materials is also very important for product characterization. Vigene Biosciences is a world leader in viral vector manufacturing and analytic assays. We are providing these extensively analyzed AAV reference materials with viral particle concentrations and full/empty ratio.
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AAV Reference Materials (Empty Capsids)

Recombinant Adeno-associated virus (rAAV) is a widely used gene delivery tool for research and clinical applications. High quality and high purity reference materials (empty capsids) can be used as negative controls or reference materials in quality control assays, including HPLC, ELISA, etc. Vigene Biosciences is a leader in viral vector manufacturing and analytic assays. We are providing well-characterized AAV reference materials (empty capsids) to meet the industrial needs.
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Need Custom AAV Reference Materials?

Although 6 different AAV serotypes of reference materials are offered, if you need a different serotype or a larger scale, we can provide custom productions for you, tailored to your specific needs. The same production, purification methods and analytical assays will be followed.

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Need AAV Packaging Service?

We have two types of AAV viral vector packaging services, research grade level and full CGMP grade level. We can assist you in your viral vector needs from concept to commercialization. Our team of experienced scientists can provide help at all stages, from designing your custom viral vector to generating AAV viral particles that tailored to your needs. With a 17-year track record of CGMP viral vector manufacturing, Vigene can provide high quality CGMP AAV manufacturing using flexible production platforms, including adherent 293 cells, suspension 293 cells and SF9 cells.

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Need Plasmid DNA Production?

The most common method of AAV production uses triple transfection, which requires plasmid DNA. Vigene offers the full range of plasmid manufacturing services for applications ranging from preclinical research studies all the way up to clinical trials and commercial manufacturing. We have the capacity and capability to manufacture plasmid according to individual client specifications.

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Reference materials are controls or standards for quality control assays and methods. In the field of gene & cell therapy, reference materials are critical for comparability between studies and clinical trials. Previously, the only available AAV reference materials are provided by ATCC over a decade ago. As a leader in AAV production and analytical assays, Vigene is now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference materials are extensively analyzed with molecular based assays and transmission electron microscope.

Commercially supplied reference standards obtained from a reputable commercial source can be used in addition to certified reference standards, according to FDA gene therapy CMC guidance, released in January, 2020, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)”.