GMP Viral Vectors / Vaccines

Waisman has the expertise to assist you with the cGMP manufacture of a variety of viral vectors that include adeno-associated virus (AAV), adenovirus and lentivirus, or custom viral vaccines such as enteroviruses, rhinovirus, etc. Our top priorities are to streamline our platform processes or work with you to design a process that meets your specific needs and expedites your transition to the clinic. Whether your intended clinical use is direct injection or ex-vivo transduction, our viral vector team has years of experience in the production, purification, and characterization of viral products. Additionally, Waisman has created and fully tested a cGMP compliant HEK293 Master Cell Bank (adherent and serum free/ suspension) for use as a host cell system for viral vector production. Custom cell banks can be produced as well. All viral vector production campaigns are performed in our ISO Class 7 Mammalian Suites.

Adeno-Associated Virus

Waisman has recently developed a scalable suspension culture-based HEK transfection process for AAV production with typical yields in the 104-105 vg./cell. In addition we have adenovirus helper and select rep/cap plasmids available for use in manufacturing.

Process Specifications

  • Serum-free suspension HEK293 triple-transfection based process at 2.5-50-250L scale
  • Robust TFF concentration and ion exchange purification steps
  • Iodixanol gradient ultracentrifugation optional processing
  • Full QC release panel testing including access to electron microscopy for empty:full analysis
  • In-house GFP reference standards for cell-based assay development

Adenovirus

Our manufacturing scientists have developed a scalable and reproducible production method that yields purified adenovirus for clinical trials in lot sizes of 1015 – 1016 viral particles. This robust process is designed to minimize equipment cleaning requirements and eliminate the possibility of product cross contamination.

Process Specifications

Electron micrograph of adenovirus produced at WB

  • Disposable chromatography systems capable of handling culture volumes in excess of 35 liters
  • Disposable filter units that remove cells and cellular debris down to 0.22 um, maintaining virus recovery and activity
  • Robust TFF concentration and ion exchange purification steps
  • Final formulation based on client requirements
  • QC assay panel for release testing and characterization includes activity titer, purity determination by HPLC, and VP/IU determination
  • In house characterized reference standard for assay comparisons

Lentivirus

Our manufacturing scientists have developed a scaleable/closed system process for lentivirus production in adherent 293FT cells that ranges in size format from tissue culture flasks to multi-tray cell factories depending on your batch size requirements.

Process Specifications

  • Optimized calcium phosphate transduction protocol
  • Closed system purification/concentration processing (TFF/ultracentrifugation)
  • In-house p24 ELISA and RT-PCR assays
  • Biological activity (TU/ml) assay development available (flow cytometry/immunostaining of transduced cells)
  • Transfection yields typically 107 copies/ml range
  • Final product yields typically 109 copies/ml range

GMP Viral Vectors /  Vaccine Highlights

  • Complete gene therapy capabilities (AAV, Ad, lenti)
  • Envelope / Non-envelope viruses
  • DNA / RNA viruses
  • 50-250L bioreactor / multi-tray formats
  • Disposable/scalable chromotography
  • In-house reference standards