Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.
**TOP 10 LIFE SCIENCES PODCAST**
Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?
Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?
Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?
There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.
I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.
Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:
- Master bioprocess development with confidence and clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I can’t wait to help you do biotech the smart way.
Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.
Ready to transform your biomanufacturing journey? Let's dive in!
Next Steps:
Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call
🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders
Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com
For sponsorship opportunities, contact us at hello@bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
210: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 2
From pandemic-speed vaccine deployment to AI-powered process control, what separates hype from real manufacturing transformation?
The biotech industry faces a fundamental challenge: how do you maintain rigorous quality standards while accelerating development timelines, personalizing therapies, and adopting transformative technologies? The answer isn't found in chasing every innovation trend, it's in understanding which changes create genuine value and when to implement them across the product lifecycle.
Irina Ramos brings a perspective earned through high-stakes execution. After leading the global technology transfer of AstraZeneca's COVID-19 vaccine, a project that compressed typical timelines while maintaining uncompromising quality standards, she's applying those lessons to the industry's next wave of challenges: phase-appropriate CMC strategy, the practical realities of AI integration, and building teams that bridge generational experience gaps in an era of rapid technological change.
This conversation cuts through the noise. Irina discusses when continuous processing actually makes strategic sense (hint: it's not always the right answer), why AI in bioprocessing requires more human expertise rather than less, and the collaborative frameworks that enabled one of the fastest vaccine rollouts in history—lessons directly applicable to your current CMC challenges.
Episode highlights:
- How the biotech community is constantly changing, and the importance of adaptability for future scientists (00:00)
- Navigating phase-appropriate CMC strategy: What to focus on in early clinical phases and which decisions set the foundation for compliance (02:36)
- Scenarios for switching from batch to continuous processing, including barriers and benefits for early-stage vs. established products (02:58)
- Lessons from leading AstraZeneca's COVID-19 vaccine technology transfer: Collaboration, rapid regulatory communication, and mission-driven teams (05:20)
- Adapting lessons from the pandemic for ongoing drug development—balancing speed and risk while maintaining quality (08:24)
- Realistic perspectives on integrating AI in bioprocessing: demystifying its applications, emphasizing human-critical oversight, and practical use cases in manufacturing (10:40)
- Key skills for scientists in a biotech world shaped by AI—why foundational understanding and strong mentorship matter (13:51)
- Bridging experience gaps: How to foster collaboration and creativity between new and established professionals in regulated environments (15:45)
- Final takeaway: Start small, remain mission-driven, and remember that one size does not fit all in continuous manufacturing (17:15)
Whether you're evaluating process platform decisions for Phase I programs, building cross-functional teams for tech transfer, or determining which digital tools deserve investment beyond the buzzword, this episode provides decision frameworks grounded in real-world execution at global scale.
Connect with Irina Ramos:
LinkedIn: www.linkedin.com/in/irinaramos
Next step:
Need fast CMC guidance? New on-demand CMC advisory → Learn more here
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.