))
Ravi Samavedam: On demand clean rooms for clinical trial supply
Manage episode 382347589 series 3526489
Treść dostarczona przez Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.
This week we speak to Ravi Samavedam, Chief Innovation Officer for Azzur Group, about how on demand clean rooms can transform the business model for biotechs.
We start out by exploring what the standard two choices biotech’s typically have for clinical trial manufacturing:
- Building their own infrastructure
- Outsourcing to a contract manufacturing organization
Both options have pros and cons. Many of the cons can be mitigated by the third option that Ravi suggests - renting the infrastructure. This enables the biotech to keep control with the manufacturing process and keep experimenting, while avoiding the upfront investment in the infrastructure that may change.
We also dive into the compliance of the facilities, and how outsourcing the quality assurance of the facilities themselves can allow the biotech’s to focus on the production process and science.
Even though the clean rooms for the different companies are in the same facilities, there is no exchange of air or supplies between the rooms - and also limited exchange of ideas between the individual production lines due to confidentiality.
As a small biotech it is easy to fall into the trap of going overboard with GMP regulation adherence. And how GMP stamina is necessary to know where to draw the line of sufficient quality.
Guest:
Ravi Samavedam
https://www.linkedin.com/in/ravi-samavedam-65a8345/
Azzur
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
64 odcinków
Udostępnij
