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Ravi Samavedam: On demand clean rooms for clinical trial supply
Manage episode 382347589 series 3526489
Το περιεχόμενο παρέχεται από το Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. Όλο το περιεχόμενο podcast, συμπεριλαμβανομένων των επεισοδίων, των γραφικών και των περιγραφών podcast, μεταφορτώνεται και παρέχεται απευθείας από τον Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal ή τον συνεργάτη της πλατφόρμας podcast. Εάν πιστεύετε ότι κάποιος χρησιμοποιεί το έργο σας που προστατεύεται από πνευματικά δικαιώματα χωρίς την άδειά σας, μπορείτε να ακολουθήσετε τη διαδικασία που περιγράφεται εδώ https://el.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
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