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
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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
209: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 1
The biotech industry operates under constant tension: we work with products that directly impact human lives, demanding rigorous controls and validation at every step. Yet standing still means falling behind. The question isn't whether to innovate, it's how to do it without compromising the quality and safety standards that define our industry.
Irina Ramos has lived this paradox throughout her career. As a downstream processing leader who's guided CMC programs from early development through global regulatory filings, she helped orchestrate the worldwide transfer of AstraZeneca's COVID-19 vaccine—a masterclass in balancing speed, scale, and uncompromising quality standards. Now, she's championing a vision that sounds almost radical: lights-out biomanufacturing facilities where continuous processes run at steady state with minimal human intervention.
In this conversation, Irina shares the unfiltered reality of building innovation cultures in conservative environments, the surprising drivers behind continuous processing adoption, and why the industry's careful nature isn't a barrier to transformation. It's the foundation for sustainable innovation.
Discussion highlights:
- Why conservatism is vital in biotech—and how to balance it with innovation (00:00)
- The vision for "lights-out" manufacturing and if bioprocess facilities could run with minimal human intervention (02:50)
- Irina Ramos's career story and the lessons her "happy accidents" teach junior scientists (03:53)
- Mindset shifts: Transitioning from scientist to innovation leader in CMC development (06:29)
- Building an innovation culture in a conservative, highly regulated industry (08:07)
- Essential mindsets for scientists to thrive and innovate in biotech environments (11:22)
- Coordination strategies for effective communication across stakeholders, departments, and geographies (13:52)
- The misconceptions of continuous manufacturing and what actually drives its adoption (17:09)
- What's hot in continuous biomanufacturing: trends, global perspectives, and how real-time analytics can change process control (21:12)
- Guiding principles for choosing between hybrid or end-to-end continuous processes (23:46)
- Practical tips on implementing control strategies and real-time monitoring in manufacturing (25:01)
If you're navigating the shift from batch to continuous processing, leading cross-functional innovation initiatives, or wondering how to advocate for new technologies without disrupting validated processes, this episode offers practical frameworks you can apply immediately.
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.