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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists
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58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2
Manage episode 421054875 series 3525243
Το περιεχόμενο παρέχεται από το David Brühlmann: Biotech Entrepreneur & Cell Culture Technology Innovation Aficionado, David Brühlmann: Biotech Entrepreneur, and Cell Culture Technology Innovation Aficionado. Όλο το περιεχόμενο podcast, συμπεριλαμβανομένων των επεισοδίων, των γραφικών και των περιγραφών podcast, μεταφορτώνεται και παρέχεται απευθείας από τον David Brühlmann: Biotech Entrepreneur & Cell Culture Technology Innovation Aficionado, David Brühlmann: Biotech Entrepreneur, and Cell Culture Technology Innovation Aficionado 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.
Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.
Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.
Key Takeaways:
- Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring product consistency—a game-changer in the industry's quest for reliability.
- By adopting a phased approach to process development rooted in QbD, companies can streamline experimentation, minimize resource expenditure, and accelerate time-to-market, amplifying efficiency by up to 40%.
- Embracing innovation, such as machine learning and digitalization, holds the key to unlocking new horizons in CMC development, paving the way for a future where creativity and regulatory compliance converge seamlessly.
Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.
Connect with Matthias Müllner:
LinkedIn: https://www.linkedin.com/in/matthias-muellner
Next Step:
Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
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