GMP Viral Vectors / Vaccines

Waisman has the expertise to assist you with the CGMP manufacture of a variety of viral vectors that include custom viral vaccines and gene therapy viral vectors. 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.

Custom Viral Vaccines

Our manufacturing scientists have developed scalable/closed system processes for a variety of custom viral vaccine products manufactured in either suspension bioreactors or adherent culture technologies.

Example Experience

• Fully aseptic process for an engineered viral vaccine manufactured in adherent Vero cells
• Viral vaccine challenge material manufactured in a novel human diploid fibroblast cell line
• Purification by column chromatography
• Closed system purification/concentration processing (TFF/ultracentrifugation)

Adenovirus

Our manufacturing scientists previously developed a scalable and reproducible production method that yields purified adenovirus for clinical trials in lot sizes of 10¹⁵ – 10¹⁶ viral particles at 50L scale, further scalable to 250L production. The process was designed to minimize equipment cleaning requirements and eliminate the possibility of product cross contamination.

Process Specifications

• Disposable filter units that remove cells and cellular debris down to 0.22 um, maintaining virus recovery and activity
• Benzonase treatment for degradation of host DNA impurities
• Downstream chromatography systems for initial capture and polishing 
• Robust TFF concentration and buffer exchange
• 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

Adeno-Associated Virus

Manufacturing using a scalable suspension culture-based HEK transfection process for AAV production with typical yields in the 10⁴-10⁵ vg./cell. 

Process Specifications

• Experience with serum-free suspension HEK293 triple-transfection based processes 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
• Experience cell-based assay development

GMP Viral Vectors / Vaccine Highlights

• Complete viral vector capabilities (AAV, Adeno)
• Custom Envelope / Non-envelope viruses
• DNA / RNA viruses
• 50-250L bioreactor / multi-tray formats
• Disposable/scalable chromatography