Virus Manufacturing

VectorBuilder has extensive expertise in producing many different types of viruses. We can provide viruses of different scales and quality attributes to meet the full range of demands along the gene therapy drug development pipeline. We have established and validated platform technologies for large-scale GMP manufacturing of adeno-associated virus (AAV) and lentivirus. We also have experience producing other types of viral vectors such as adenovirus, MMLV, herpes simplex virus (HSV), and vesicular stomatitis virus (VSV). We can produce viruses in several grades that cover different downstream applications including drug discovery research, pre-clinical studies, clinical trials and commercialization.

Different Grades of Virus Offered
  • Research-grade virus

    Research-grade virus is suitable for basic research and drug discovery studies. It is produced in conventional cell culture facilities. Stringent QC assays are performed to ensure the quality of the virus meets the standards requested by customers.

    Visit here to learn more about our research-grade virus
  • GMP-like virus

    GMP-like virus is suitable for pre-clinical studies including drug safety and metabolism testing in animals. The manufacturing of GMP-like virus follows key features of GMP guidelines, such that the production process and quality attributes are comparable to GMP with document control and traceability. GMP-like grade is therefore intended to be a small-scale mimic of the final GMP product, but with significantly lower cost and much faster timeline. Product release is accompanied by a certificate of analysis (COA). TSE/BSE statement can be provided upon request.

  • GMP virus

    GMP-grade virus is produced in our certified GMP cell culture suite following strict GMP guidelines. A comprehensive quality assurance system is embedded throughout the manufacturing process, including an array of in-process and release QC assays to ensure that the virus meets customer specifications and regulatory standards for quality and safety. At product release, a COA and a batch release report fully documenting the production process are provided.

Workflow for GMP-like and GMP Plasmid Production

Vector characterization

Process development

Cell banking

Engineering run

GMP manufacturing

QC and release

Fill/finish

  • RE digestion
  • Sequencing
  • Cell line

    development

  • USP/DSP
  • Analytical

    development

  • MCB
  • WCB
  • Closed system
  • General/physical

    properties

  • Identity
  • Purity
  • Safety
Platform Technologies
  • Adeno-associated virus (AAV)

    We package AAV in HEK293 cells under either adherent conditions (Cell Factory 10 or iCELLis 500) or serum-free suspension conditions (up to 200 L single-use bioreactor). We also package AAV in suspension Sf9 insect cells. We can achieve a scale of up to 1017 GC AAV per batch.

  • Lentivirus

    We package lentivirus (2nd and 3rd generation, pseudotyped with VSV-G or other viral surface proteins) in HEK293, under either adherent growth conditions (Cell Factory 10 or iCELLis 500) or serum-free suspension conditions (up to 200 L single-use bioreactor). We can achieve a scale of up to 1011 TU per batch.

View here to learn more about our process development services View here to learn more about our QC and stability study services

To inquire about our GMP manufacturing services email us a cdmo@vectorbuilder.com. For other questions contact us.