Facilities


  • GMP manufacturing of bulk drug substance (BioAPI)
  • BioAPI filling (aseptic) in bags or flasks
  • BioAPI release
  • Multiproduct manufacturing plant
  • Stability studies (ICH-guidelines)
  • Process validation
  • Cleaning validation
  • Baculovirus development (MVB)
  • Process development in lab-scale
  • Primary recovery
  • Purification development
  • Bioassay development
  • Analytical development
  • Tech transfer and scale-up

Bionaturis-Jerez

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  • Controlled disposable system: each larvae acts as a mini-bioreactor. It´s self-optimized, self-regulating, keeping internal sterility, homeostasis, oxygen level, pH, and nutrient concentration.
  • No pathogenic virus in manufacturing.
  • BioAPI release
  • Densely packed FLYLIFE optimizes space. Self-contained organism reduces operator intervention, sterile handling, and process control.
  • Scale-up process is linear. Oxygen mass transfer, shear, and gas mixing are inconsequential. High speed. From cDNA to product releases in 10-12 weeks.
  • Yield: as much as 50 times higher than the same protein manufactured by insect cell culture.

The project “FLYLIFE Manufacturing plant” has been funded by the Ministerio de Ciencia e Innovacion (Spain) through European FEDER funds:

  • PCT-AA11858537-2009 / PCT-010000-2009-007 “LABORATORIO DE INVESTIGACIÓN + PLANTA PILOTO PROTEINAS RECOMBINANTES” (ACTEPARQ 2009-2010. Loan: 948.146,00€)
  • PCB- A11858537-2010 / PCB-010000-2010-027 “EQUIPAMIENTO DE INFRAESTRUCTURA: LABORATORIO DE INVESTIGACION + PLANTA PILOTO PROTEINAS RECOMBINANTES” (INNPLANTA 2010. Loan: 605.543,00€)
  • REI-100000-2010-212 ”BIONATURIS INDUSTRIAL: PRODUCCIÓN DE PROTEÍNAS RECOMBINANTES” (REINDUS 2010. Loan: 600.000€)
  • REI-100000-2012-198 ”BNT DERMOCOSMETICS” (REINDUS 2012. Loan: 593.673€)