Last 26th of April, LeanBio S.L. organized an event titled as “insights into biotherapeutics development”. It was an afternoon where CMC strategies for DS and DP of biotherapeutics in compliance with ICH guidelines were discussed. There were three talks given by Julià Blanco, CEO of AlbaJuna Therapeutics and researcher at IrsiCaixa, Andreu Soldevila, CEO and founder of LeanBio S.L. and Gemma Lahuerta, director of parenteral development at Reig Jofré. After that, there was an interesting roundtable discussion, where questions related to CMC lead to a proactive discussion about technology, strategy and regulation evolution. Interactions between analytical and process development as well as between drug substance and drug product were debated. The general conclusion was that key to success is related to an early and powerful R&D program to guide product development, in order to minimize time to market and cost by minimizing product and process changes throughout life cycle of the project. It was highlighted the need of contacting specialized CDMO for DS and DP development at early stages of the project to maximize success of the product.

 

 

 

 

 

 

 

To end up, there was a guided tour of the installations of LeanBio S.L. where all the laboratory could be seen. Explanations were given by Albert Font, the operations manager of LeanBio S.L. Finally, there was a cocktail connection at a terrace of the Parc Científic of Barcelona.