GMP Viral Vectors / Vaccines

GMP Viral Vectors /  Vaccine Highlights

  • Envelope / Non-envelope viruses
  • DNA / RNA viruses
  • 35L bioreactor / multitray formats
  • Disposable/scalable chromotography
  • In house reference standards

Waisman has the expertise to assist you with the cGMP manufacture of a variety of viral vectors that includes adenovirus, AAV and lentivirus. Our top priority is to work with you to design a process that meets your specific needs and expedites your transition to 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 Banks (adherent and serum free/ suspension) for use as a host cell system for viral vector production.  All viral vector production campaigns are performed in our ISO Class 7 Mammalian Suites (Facility/Mammalian Suites).

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 WCBF

  • 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