Andreu Soldevila
LeanBiopro, Spain
Title: Leanbioproduction of biosimilars for small to mid-size pharma companies
Biography
Biography: Andreu Soldevila
Abstract
Andreu Soldevila 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.