Overview

VectorBuilder is a full-service CDMO with extensive expertise in manufacturing GMP-grade gene therapy vectors. We support the full spectrum of vector design, production and QC needs along with the entire gene therapy drug development pipeline. Our highly experienced team has worked with thousands of customers to create research-grade vectors for the early discovery stage, GMP-like vectors for the pre-clinical stage, and full GMP-grade vectors for the clinical stage.

Process Development
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We can develop and optimize GMP manufacturing processes for a variety of gene therapy vectors including plasmid DNA, adeno-associated virus (AAV), lentivirus, adenovirus, herpes simplex virus (HSV), and several other viral vectors.
Analytical Development
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We can develop and validate all the in-process and release QC assays required for the production of GMP-grade gene therapy vectors.
Plasmid Manufacturing
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We can manufacture GMP-grade plasmid DNA at various scales, employing antibiotic-free and animal component-free production methods.
Virus Manufacturing
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We can produce GMP-grade AAV and lentivirus using our platform technologies. We also have experience producing other types of viral vectors such as adenovirus, MMLV, HSV, and vesicular stomatitis virus (VSV).
Cell Banking
We can generate GMP-grade Master Cell Banks (MCBs) and Working Cell Banks (WCBs) for E. coli, mammalian cells and insect cells, derived either from our in-house validated cell lines or customer-provided cell lines.
Fill/finish
We can do manual or automated aseptic filling of the DS/DP into glass vials (0.5 to 2 ml) or cryo bags. We have the capacity to complete >3000 vials per day.
Regulatory Support

We work closely with our customers to provide regulatory support at each critical milestone of their drug development process. These include:

  • Consultation for regulatory strategy
  • Support for IND-enabling documentation
  • Preparing CMC documentation for clinical trial and BLA filing
  • On-site audit by regulatory authorities
  • Addressing manufacturing questions from HAs
Technology Transfer
We can provide technology transfer with best practices including detailed bill of materials, well-documented production process, and fully qualified analytical methods used in the manufacturing of the gene therapy vector.

Our comprehensive quality system is embedded in every aspect of our GMP manufacturing process that spans facilities, supplies, production, fill/finish, storage, in-process and release QC, and personnel. Our company culture places great emphasis on quality, innovation, continuous improvement, and “white-glove” customer service. As such, we can consistently meet and exceed customer expectations. We also strive to achieve rapid turnaround and affordable prices while maintaining high quality and full regulatory compliance.

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