Products

E.coli LBP FTO I expression System comes from Leanbio development program, providing best performance, yield  and quality . It is totally compliant  with guidelines and  required information is availablo on request for dossier submission  into regulatory agencies. It does not have any pro/phage  in the  genome which enables manufacture of  RCB, MCB and WCB  and it 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 >50%
  • Inducible with IPTG
  • Tight control with no leakage
  • USP platform media and process for high cell density fermentation
  • Target protein expression >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, camel antibodies or ScFv, Fab, Chimeras, Fc fragments.

 

Host cell DNA kit was developed to overcome limitations in the field  of Biopharma which drive companies to excessive cost following or lack of sensitivity  using Standard  methods.  Use of RT-qPCR  in the development of a Biologic  means investments of >100k€ whereas picogreen   is sensible to  Biological product matrix interference.   Leanbio HC DNA method combines  highest sensitivity, primer free PCR and  isothermal  PCR to provide a straightforward solution  to avoid matrix interference and minimize cost for Host cell DNA determination in Biopharmaceutical products.

Main characteristics of the kit are described as follows:

  • Highest sensitivity, <femtogram/mL
  • 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.