FULLY SCALABLE
GENE THERAPY VECTOR PRODUCTION

The increasing number of gene therapy-based discovery programs in the biotech and pharma industry is driving a greater need for the scalable production of gene therapy vectors.

Our suspension CAP-GT cell lines provide a novel platform for the industrial production of viral vectors. CAP-GT cell lines are fully documented and comply with regulatory requirements. Growing in serum-free suspension culture at high densities, the cells provide a fully scalable vector production platform.

HIGH TITER VECTOR PRODUCTION

The CAP-GT production system consists of:
Human cell lines, media and processes for high titer production of

CAP®GT MEETS REGULATORY REQUIREMENTS

  • Cell line developed according to industrial standards
  • Complete documentation of cell line development and full certification of materials
  • Human origin, non-tumor derived, informed donor consent
  • Fully tested master cell bank
  • Positive scientific advice from EMA (PEI)
  • Biologics Master File for CAP Technology submitted to U.S. FDA

SCALABILITY OF CAP®GT

  • Suspension cell line, growing as isolated single cells
  • Growing to densities > 2x10e7 cells/ml in standard fed batch
  • Established processes with multiple bioreactor formats

SERUM-FREE SYSTEM

  • CAP-GT cells are adapted to serum free growth
  • Compatible with different serum free media
  • Optimized media CAP-CDM:
    • Serum-free
    • Chemically defined
    • Available in GMP quality
    • Media available as powder in different batch sizes according to your production needs

CAP®GT CONTRACT MANUFACTURING SERVICES

  • Master viral seed stocks
  • cGMP production of viral vectors
  • Quality Control / Quality Assurance Services
  • Fill and finish
  • Support of dossier filing with Regulatory Authorities

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CAP®GT EXAMPLES

  • Lentivirus production
  • Adenovirus production