Products

E. coli LBP FTO I expression System comes from LeanBio S.L. development program, providing best performance, yield and quality of the product under development. It is totally in agreement with ICH guidelines, and the required information for dossier submission into regulatory agencies is available on request. It does not have any prophage sequences in the genome, which enables manufacture of RCB, master cell banks and working cell banks. This is a crucial step for risk mitigation in most valuable raw material for biologics manufacture. Main characteristics of the product are described as follows:

  • E. coli based strain with freedom to operate
  • Customized compatible vectors with freedom to operate
  • Highest expression levels, more than the 50%
  • Inducible with IPTG
  • Tight control with no leakage
  • USP platform media and process for high cell density fermentation
  • Target protein expression, more than 15g/L
  • Customized Research cell bank is available on demand
  • Tested in biopharmaceuticals, both biosimilars and new biological entities, vaccines, enzymes, growth factors, cytokines, peptibodies, nanobodies, mini bodies, scFv, Fab, chimeras and Fc fragments.

 

Host cell DNA kit was developed to overcome limitations in the field of biopharma, which drive companies to excessive cost investment, followed by a lack of sensitivity using standard methods. RT-qPCR usage in the development of a biologic means investments of more than 100000€, whereas PicoGreen® is sensible to biological product matrix interference.  LeanBioPro host cell DNA method combines highest sensitivity, primer free PCR and isothermal PCR to provide a straightforward solution, avoiding matrix interference and minimizing costs for Host cell DNA determination in biopharmaceutical products. Main characteristics of the kit are described as follows:

 

  • Highest sensitivity, less than one femtogram per millilitre
  • Primer free PCR
  • Isothermal PCR in a thermostatic equipment avoiding RT-PCR investment
  • End point DNA quantitation
  • Available for E. coli, yeast and mammalian processes and products for IPC and QC
  • Development of the method and R&D testing at LeanBio and Transfer to client or GMP site.