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.