Strain and Cell line development platform
LeanBio S.L. offers to his clients proprietary and/or open expression systems with Freedom to Operate to manufacture any recombinant protein in E. coli LBP FTO I, CHO LBP FTO II, as well as yeast platforms like P. pastoris and S. cerevisiae. Activities performed correspond to Gene design and synthesis, Molecular cloning, manufacture and characterization of Cell banks for any of the expression systems described.
LeanBio S.L. has upstream (USP) suites for microbial and mammalian cell culture, downstream (DSP) suites for primary recovery and full purification of a biotherapeutics product. USP activities correspond to media and feed screening, batch and feed batch development and manufacture which impact in titter and quality biopharmaceutical product, whereas DSP activities correspond to solubilization and refolding of insoluble proteins, Clarification, Chromatography steps, all type of filtrations and diafiltrations, in order to provide high purity and high yield cost-effective manufacturing process.
Analytical development programs provide knowledge on product at any operation unit stage, as in process control, quality control or characterization of reference standards. Activities performed are in line with ICH guidelines for product characterization and analytical method validation when required. Leanbio S.L. provides full coverage of analytical tests in terms of structural analysis, Identity tests, Content, Potency, Product related variants, process related variants and excipients in formulation.
Formulation platform screens pH, buffer, excipients, concentration and stabilizing agents to maximize shelf life of the biopharmaceutical product. LeanBio is focused in pre-formulation studies and has partners for final pharmaceutical form as DP. Activities executed in pre-formulation studies provide knowledge on stability of the product in forced degradation studies and stress, accelerated and long term stability studies in pre-formulated DS. Specific Analytical tools such as biophysical screening altogether with traditional methods are key for proper formulation development and maximize success for DP development whilst minimizing cost of the program.