OF COMPLEX RECOMBINANT PROTEINS

SCALABLE MANUFACTURING

CEVEC’s CAP®Go Technology enables the recombinant production of complex and highly glycosylated proteins such as Blood Coagulation Factors, Laminins, Growth Factors and Plasma Proteins.

Recombinant proteins expressed on conventional platforms often do not match the glycosylation and pharmacokinetic profiles of their plasma-purified counterparts. CEVEC’s CAP®Go technology solves this by enabling the optimized, high-level expression of N- and O-glycosylated proteins.

CELL LINE DEVELOPMENT
FOR THE EXPRESSION OF
GLYCO-OPTIMIZED PROTEINS

HUMAN CELLS

  • Authentic human glycosylation of complex proteins
  • No potentially immunogenic non-human carbohydrate residues
  • High specific activity

HIGH PRODUCT TITERS

  • Up to 10 times higher titer than conventional cell lines
  • Minimal product aggregation
  • Cost-effective large scale production

REDUCED PRODUCTION COST

  • Consistent protein quality resulting in reduced downstream costs
  • Minimal batch-to-batch variations
  • Homogenous glycosylation patterns

With CAP®Go, several complex recombinant proteins have been produced successfully, like Coagulation Factors, Laminins, Plasma Proteins, Cytokines, Ion Channels, Growth factors, Virus Envelope Proteins, and further high molecular mass, multimeric proteins.

HOW TO ACCESS OUR TECHNOLOGY AND SERVICES

We provide full CMC Support up to Phase II Clinical Materials and Licenses to the CAP®Go Technology for your pharmaceutical product.

  • Cell line development using the appropriate CAP®Go line
  • Process development
  • cGMP cell banking
  • Support in GMP manufacturing

Choose from our comprehensive TOOLBOX OF CAP®GO CELL LINES expressing glycoproteins with:

  • Enhanced sialylation for increased half-life
  • Reduced antennary fucosylation
  • High degree of galactosylation of N-glycans
  • High or low N-glycan antennarity as required
  • Homogenous tailored O-glycosylation patterns
  • Human plasma identical glycans
  • Proper folding and secretion

CELL LINE DEVELOPMENT

CEVEC offers cell line development services based on its CAP® Go platform including

  • Construction of optimized expression vectors
  • Serum- and animal component-free cell line generation
  • Stable pool generation and single cell cloning

PROCESS DEVELOPMENT

  • Optimization of batch/fed-batch processes
  • Stirred tank bioreactors, Wave, and/or shaker flasks
  • Based on serum-free, chemically defined suspension culture media and feeds
  • Lab to production scale
  • Scale-down studies
  • Support in downstream processing

CGMP MANUFACTURING

Based on our CAP®Go platform we offer to support you in identifying the ideal CDMO partner and provide all necessary tech transfer, including

  • cGMP Master and Working Cell Bank production
  • cGMP bulk protein production
  • Quality Control / Quality Assurance Services
  • Support of dossier filing with Regulatory Authorities.
© CEVEC Pharmaceuticals GmbH 2020