Mary Ruberry from CHI interviews Eric Lacoste from Sanofi-Aventis on strategies for managing successful bioprocesses
Speaker at PEGS Europe’s “Bioproduction: Scaling Up & Down” Conference in Lisbon, Portugal, November 5-6, 2015
Eric Lacoste, Ph.D., ADC Team Leader, Chemistry & Biotechnology Development, Sanofi-Aventis Research & Development
How do project constraints affect your approach?
Eric: It is critical. We are not in a free/open world with unlimited resources. You have to take into account all the constraints to build a realistic and pragmatic plan to reach the requested/expected quality in due time.
How do you apply QbD strategies?
Eric: We build our strategy based on QbD even if I would not claim it, as some notions are difficult to agree on. Based on prior knowledge, we build development plans that should give us the maximum answers in the minimum of time/trials. We have to know our product as fast as we can to ensure during all the project’s life a reproducible quality.
What are the processes you undertake to streamline purification development?
Eric: My team will work in parallel with others, but with clear milestones where comparability or verification can be made that all is fitting well. Design of Experiments is almost our daily bread.
Eric: To conclude, team spirit across functions with good communication and risk sharing as well as (obviously) to be driven toward same project goals are key. Clear project goals have to be defined and shared with all shareholders.