Lean bioproduction of biosimilars for small to mid-size pharma companies

5^th European Biosimilars Congress

June 27-29, 2016 Valencia, Spain

Andreu Soldevila

LeanBio Pro, Spain

Keynote: J Bioanal Biomed

Abstract :

I will present approach for Biosimilar development at Leanbiopro, providing straightforward solutions for the Lean Bioproduction of Biologics, especially Biosimilars in a Quality driven and risk based approach to minimize cost and time to market for our clients. Leanbio will provide solutions for mid-size companies, offering expression systems with freedom to operate, will emphasize in life cycle of analytical methods to support innovator drug characterization, specifications and IPC as proper control strategy and will present leanbiopro approach for life cycle in process development to support early stages of development to process characterization which will provide knowledge to support CMC for nonclinical and clinical trials in compliance with regulatory guidelines.

Biography :

Andreu Soldevila has done PhD in Biology, MSc in Biotechnology, MSc in Microbiology and Genètics, MSc in Environmental Sciences, BS in Biology and BS in Biotechnology with 16 years of experience in the biotechnology and bio-pharmaceutical industry. He developed as a professional in the area of small molecules, peptides, biotherapeutics and in the last years specially in New Biological entities and Biosimilars. Professionally, he is interested in functions related to science and business (research and development, business development, technology transfer, project management) in the biotech and biopharma sectors.

Email: Asoldevila@leanbiopro.com