Microbial Strain Development
GTP Bioways has extensive experience developing microbial strains for the GMP manufacturing of biologics.
GMP-compliant microbial strain development services
We know how important it is for the successful development of your biotherapeutic candidate to obtain an efficient production strain. Drawing on many years of experience, we offer robust microbial strain development services. Our team will handle the entire development from synthesis to the generation of a stable and thoroughly characterised Master Cell Bank (MCB).
With a complete history of all materials (microbial strain, plasmid) and full traceability of every operation performed, you will have all the documentation required by the regulatory authorities.
Expert E. coli strain development services
To develop high-producing E. coli strains, our approach is to screen a complete set of parameters, from which we select the strain and expression conditions allowing for the highest productivity and the production of a protein with the required quality attributes.
Depending on the specificities of your molecule, we will design a custom package including the screening of different parameters such as gene sequences, promoters, expression strains, expression strategies (soluble/insoluble, periplasmic/cytoplasmic, co-expression with chaperones), plasmid stabilisation sequences and expression conditions (induction, media, temperature and kinetic).
P. pastoris strain development services
P. pastoris (renamed Komagataella phaffii) is an established, FDA-approved and highly competitive expression host.
Our team has successfully produced a diversity of recombinant proteins (enzymes, cytokines, antibody-derived fragments…) using the methanol-inducible AOX promoter or the constitutive GAP promoter.
By working on the design of an optimised strain for the production of your specific protein and performing an extended screening of up to several thousand clones, we will be able to identify the highest producers. We will use the adequate analytical methods all along the strain development process, ensuring we select a clone that will produce a molecule with the expected quality attributes.
Integrated CDMO services from R&D to cGMP manufacturing
Our microbial strain development services can be used as stand-alone services, but are more often integrated into complete process development & GMP manufacturing programmes.
Are you looking for an expert partner to develop a highly producing and GMP-ready microbial strain?
Connect with our team and we will get back to you shortly.
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