LeanBio S.L. goes one step further in biopharmaceutical products development for drug substance (DS) and drug product (DP).
LeanBio approach puts together a deep knowledge in biotherapeutic development with “lean thinking” and ICH guidelines compliance in order to minimize time to market and cost through a quality-by-design (QbD) based strategy, guiding product development from knowledge and understanding of the product and the process.
LeanBio S.L. structures development in three cycles or stages: i) Platform development, ii) specific development and iii) process characterization in order to bring together molecules from Proof of concept (POC) to market approval, leading decision making from development with full understanding of industrial and market requirements. For it, Technological platforms related to Strain and cell line development, Fermentation development (USP), Purification development (DSP), Analytical development and Formulation Development are properly interweaved for a smooth and straightforward path to successful development of therapeutics.
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 available yeast platforms like P. pastoris and S. cerevisiae.
LeanBio S.L. is a Contract Development and Manufacture Organization for biopharmaceutical products (CDMO). We offer client tailored solutions in mammalian cell lines, plants, yeast and bacteria, providing a straightforward CMC program in accordance with ICH guidelines. We help in the manufacture of new biological entities and biosimilars, supporting POC, non-clinical and clinical trials and market supply. The company holds an ample experience in this field, having participated in the development of more than 50 new biological entities and 6 biosimilar products.
Other sectors (pharma, cosmetics, agro-food…):
We are also able to provide natural and recombinant enzymes produced in yeast and bacteria for pharma industries, from proof of concept to manufacturing scale, applicable in biocatalysis, biotransformations and biosynthesis, as well as bioactive ingredients (natural proteins, exopolysaccharides…) produced in plants, yeast and bacteria for cosmetic industry. Our company is capable of generating the desired molecule in any of the available platforms to fulfil our client’s needs.