TRANSIENT AND STABLE PRODUCTION OF VIRAL VECTORS USING CEVEC‘S PROPRIETARY CAP-GT PLATFORM

Transient transfection process optimization for individual viral vectors is performed at small scale in multiwell format, shake flasks or 24-well stirred-tank bioreactors.

Viral vector manufacturing using stable cell lines is the best option to reduce production costs and increase the reproducibility of the production process. Stable producer cell lines that continuously produce viral vectors avoid the problems and costs of transient transfections.

PROCESS DEVELOPMENT

Upstream Process Development

  • Process optimization for both, transient and stable vector production runs
  • Stirred Tank Bioreactors, Wave, and/or Shake Flasks
  • Scale-down studies for optimization by Design of Experiment
  • Upscaling from lab to production scale

Downstream Process Development

  • Development of scalable and cGMP-compliant downstream processes for AAV and LV
  • State of the art purification equipment

CGMP MANUFACTURING

CAP-GT derived clinical material for Phase I-II studies is produced
by our current CDMO partners

  • GenIbet in Lisbon/Portugal – CAP CDMO Joint Venture
  • Paragon in Baltimore/Maryland – CEVEC’s preferred CDMO in North America
  • Beckman Research Institute City of Hope in Duarte/California – Support of Phase I/II clinical trials for lentiviral and adenoviral vectors

CEVEC assists in selecting the appropriate CDMO partner, with the final choice being made by our clients.

Based on our CAP-GT Viral Vector Production Platform we offer:

  • cGMP Master and Working Cell Bank Production
  • cGMP Master and Working Viral Seed Stock Preparation
  • cGMP Gene Therapy Vector Production
  • Quality Control / Quality Assurance Services
  • Fill and finish
  • Support of dossier filing with Regulatory Authorities

Benefit from our extensive know-how and expertise and contact us at: bizdev@cevec.com