Viral Vector Manufacturing for Gene Therapy

Maximize Efficiency and Accuracy Across your Gene Therapy Development and Manufacturing Workflow

From the viral vector characterization assays that fuel discovery to potency measurement and safety assays for QC release, our gene therapy manufacturing products bring accuracy and consistency to your results.

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How We Help Viral Vector Manufacturing

Drug development and manufacturing has always been a challenging process. When the drug you are developing is a new type of treatment modality, such as a gene therapy, the challenges only increase in complexity.

At Bio-Rad, our goal is to simplify your day-to-day operations and bring clarity to your decision-making by removing complexity from your gene therapy manufacturing workflows. Through products that combine high-performance with ease-of-use and a long track record of success, we make it easy to obtain absolute quantification of viral titer, check for impurities like host cell DNA and mycoplasma contamination and evaluate viral potency for developing and deploying QC release assays. To support you in viral vector manufacturing, whether it is an adeno-associated virus (AAV), adenovirus (Ad), herpes simplex virus (HSV), or something else, Bio-Rad has proven products and a responsive and knowledgeable support team to accelerate your advanced therapeutic development.

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Adeno-Associated Virus (AAV) Gene Therapy Applications and Solutions Guide

Explore our suite of customizable products and services, ensuring efficiency, reproducibility, and reliability at every step of your therapeutic discovery, development, and manufacturing process.

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Adeno-Associated Virus Gene Therapy Applications and Solutions Guide
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Did you know?

Results from Phase 3 clinical trials show that one-time, pre-symptomatic administration of the gene therapy Zolgensma continued to show real-world efficacy even five years post-treatment.1 In the absence of treatment, children with SMA-1 would have a life expectancy of less than two years.2

Where We Help Drive Efficiency in Viral Vector Manufacturing

  • Viral Titel

    Viral Titer Determination

    Get the speed and certainty of absolute viral titer determination using Droplet Digital™ PCR (ddPCR™).

  • Viral Vector Characterization

    Viral Vector Characterization

    Develop and deploy robust virus potency assays for development and QC release.

  • Viral Vector QC

    Viral Vector QC

    Find ready-to-use assays to detect harmful contaminants such as pathogenic microbes and host cell debris.

Industry Snapshot: Globally Approved In Vivo Gene Therapies

While gene therapies in clinical trials took a pause in the late 1990s to better understand the immunogenicity and characteristics of different viral vectors,3 the past few years has seen a resurgence of interest in this promising approach. Teams around the world have developed safer and more effective vectors and, while much of the research has investigated AAV production and manufacturing, approved treatments include a range of viral vectors (Table 1).

Our specialists closely follow the latest developments in the field and are excited to support your efforts in expanding the list of approved gene therapy treatments.

Table 1. Globally Approved Gene Therapies.

Name/Trade Name
(Manufacturer)
Viral Vector Type Approved Indications Approval Year and Organization
Cancer
Talimogene laherparepvec/IMLYGIC® (Amgen) HSV1 Local recurrent unresectable cutaneous, subcutaneous, and nodal melanoma after initial surgery 2015 (USFDA), 2015 (EMA)
Mx‐dnG1/Rexin‐G® (Epeius Biotechnolgies) Retrovirus Soft tissue sarcoma, osteosarcoma, and pancreatic cancer 2007 (BFAD)
H101/Oncorine® (Shanghai Sunway Biotech) Ad5 Nasopharyngeal cancer 2005 (NMPA)
Ad‐p53/Gendicine® (Shenzhen SiBiono GeneTech) Ad5 Head and neck cancer 2003 (NMPA)
Ophthalmological diseases
Voretigene neparvovec/LUXTURNA® (Spark Therapeutics) AAV2 Leber's congenital amaurosis (Biallelic RPE65 mutation‐associated retinal dystrophy) 2017 (USFDA), 2020 (Health Canada), 2020 (TGA)
Neurological diseases
Onasemnogene abeparvovec/ZOLGENSMA® (AveXis, now Novartis Gene Therapies) AAV9 Spinal muscular atrophy (SMA) with bi‐allelic mutations in the survival motor neuron 1 (SMN1) gene in pediatric patients less than two years of age 2019 (USFDA), 2020 (EMA), 2020 (JMHW)
Metabolic diseases
Alipogene tiparvovec/Glybera® (UniQure) AAV1 Lipoprotein lipase deficiency 2012 (EMA)

*Excerpted from Zhao, et al.,2 Table 1 (available via CC-By-4.0).

More on Gene Therapy Development and Manufacturing

Articles

Resources

Webinars

Publications

Systemic Treatment of Fabry Disease Using a Novel AAV9 Vector Expressing α-Galactosidase A
Biferi MG, et al. Mol Ther Methods Clin Dev. 2020 Oct 22;20:1-17. doi: 10.1016/j.omtm.2020.10.016

Hair Cell Transduction Efficiency of Single- and Dual-AAV Serotypes in Adult Murine Cochleae
Omichi R, et al. Mol Ther Methods Clin Dev. 2020 May 13;17:1167-1177. doi: 10.1016/j.omtm.2020.05.007

Documents

Webinars

Publications

Two-Dimensional Droplet Digital PCR as a Tool for Titration and Integrity Evaluation of Recombinant Adeno-Associated Viral Vectors
Furuta-Hanawa B, et al. Hum Gene Ther Methods. 2019 Aug 1; 30(4): 127–136. doi: 10.1089/hgtb.2019.031

Using ddPCR to Accurately Quantify AAV Viral Titre and Integrity
The Manufacturing Chemist, 29 July 2021. Accessed July 15, 2022.

Documents

Documents

Documents

Publications

Insights on Droplet Digital PCR–Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy
Sugimoto H, et al. AAPS J. 2021 Mar 2;23(2):36. doi: 10.1208/s12248-021-00560-6.

Documents

Documents

Documents

References

  1. New Zolgensma data demonstrate age-appropriate development when used early, real-world benefit in older children and durability 5+ years post-treatment. Novartis. Accessed July 5, 2022. https://www.novartis.com/news/media-releases/new-zolgensma-data-demonstrate-age-appropriate-development-when-used-early-real-world-benefit-older-children-and-durability-5-years-post-treatment
  2. Finkel RS, McDermott MP, Kaufmann P, et al. Observational study of spinal muscular atrophy type I and implications for clinical trials. Neurology. 2014;83(9):810-817. doi:10.1212/WNL.0000000000000741
  3. Zhao Z, Anselmo AC, Mitragotri S. Viral vector‐based gene therapies in the clinic. Bioeng Transl Med. 2021;7(1):e10258. doi:10.1002/btm2.10258

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