Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling and manufacturing economics, continuous manufacturing and Industry 4.0 in biopharma, biologics modalities including mAbs, ADCs, and cell and gene therapies.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
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Next Steps:
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Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All
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In a world of rapid advancements in medical science and biotechnology, bioprocessing is at the forefront of healthcare innovation. Yet, despite remarkable progress, life-saving biotherapeutics remain out of reach for much of the global population.
A staggering 80% of patients worldwide lack access to the biotherapeutics they need. While bioprocessing has made impressive strides, the high cost and slow development of these treatments create significant barriers. Addressing these challenges is critical to making innovative therapies widely available.
David Brühlmann is launching a special four-part series based on his keynote at the Amphacademy, exploring bioprocessing’s revolutionary journey - from the early days of recombinant insulin to today’s groundbreaking therapies. This series will also highlight strategies to make these innovations more accessible to patients worldwide.
From Standardization to Personalization
One major challenge is the shift away from platform technologies. Traditionally, antibodies were produced using standardized CHO cell templates and purification steps, but this approach falls short for new modalities.
Personalized therapies further complicate the landscape. Autologous cell therapies, for example, require isolating, cultivating, and reinfusing a patient’s own cells. These small-batch processes are labor-intensive, less automated, and often reliant on outdated, paper-driven workflows.
Innovations in Bioreactor Design
With the rise of sensitive cell therapies, bioreactor design must evolve. Unlike CHO cells, these delicate cells require gentler handling environments. Innovations like acoustic wave bioreactors, bionic bioreactors, and specialized cell screws are emerging to optimize cell growth and improve efficiency.
The Complexity and Cost of Cell-Based Products
New bioprocessing modalities bring greater complexity. Cell-based therapies and cultivated meats are far more intricate than traditional antibody proteins, making scaling production and ensuring quality especially challenging.
High production costs further limit access. Even in regions where these therapies are approved, pricing remains a major barrier. Lowering manufacturing costs is essential to democratizing these life-saving treatments.
The shift from basic recombinant proteins to complex cell-based therapeutics is just the beginning. Overcoming these challenges - scaling production, reducing costs, and managing complexity - is key to making breakthrough therapies accessible to all.
Next step:
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech