In bioprocess development, the ability to rapidly screen conditions and predict scale-up performance can mean the difference between a successful therapy launch and costly delays. Today's Smart Biotech Scientist episode features Tom Valentin from CSEM, who's pioneering revolutionary approaches to miniaturized perfusion systems that could transform how we develop biologics.

Tom is a group leader at CSEM for Automated Sample Handling within the Life Sciences and Industry 4.0 business unit. As a mechanical and biomedical engineer, he brings a unique cross-disciplinary perspective to solving bioprocessing's most challenging miniaturization problems.

What makes this conversation essential listening:

• 96-deep-well plates are revolutionizing perfusion development: Tom reveals how CSEM's innovative fluidic lids enable continuous medium exchange in 300-microliter volumes, potentially allowing up to 96 parallel perfusion experiments with automated liquid handlers and shaker incubators
• Three critical barriers still need solving: Despite the promise, Tom identifies the key technical challenges that must be overcome: ultra-low flow rate liquid handling (imagine exchanging 300 μL over 24 hours), effective cell retention in miniaturized systems, and cost-effective real-time biomonitoring that fits within well plate constraints
• The future of process development is automated and intelligent: From pressure-over-liquid systems to advanced sensor integration, Tom outlines how companies can achieve near-autonomous perfusion screening—but warns that current sensing limitations mean viable cell density monitoring remains the "holy grail" of small-scale perfusion

This isn't just about smaller equipment—it's about fundamentally changing how we approach process development. If you're working in cell culture optimization, process scale-up, or bioprocess automation, Tom's insights reveal both the tremendous opportunities and practical realities of implementing next-generation perfusion systems.

For biotech professionals, staying ahead means embracing these high-throughput, data-rich models, allowing smarter, faster, and more predictive process development for the therapies of tomorrow.

Discover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes.

• Episode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes Everything
• Episodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos
• Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli
• Episodes 73-74: Bead-Based Assays: The Power of High-Throughput Screening with Sebastian Giehring

Connect with Tom Valentin:

LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091b

Website: www.csem.ch/en

Email: thomas.valentin@csem.ch

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/

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In this concluding episode of our series on revolutionary endotoxin detection, we continue our conversation with Anika Hoffmann about transitioning from theory to practice in the quest for more reliable, sustainable testing methods. Anika is a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland.

Having established why traditional LAL testing falls short in Part 1, we now explore how Anika's innovative KDO-based chemical analytical approach compares in real-world applications:

• Greater accuracy you can trust: The new method delivers impressive 5-10% coefficient variation (compared to LAL's 25%), works across broader pH and formulation conditions, but is still working toward the sensitivity targets needed for all pharmaceutical applications
• Clear path to regulatory acceptance: Anika outlines how companies can validate alternative methods against established standards like LAL, recombinant Factor C, or monocyte activation tests to gain approval from authorities
• Sustainable testing strategy: Health authorities and customers are increasingly demanding sustainable alternatives as horseshoe crab populations decline while testing demand rises—adopt ethical, animal-free methods now before they become an industry requirement

Most excitingly, Anika reveals her entrepreneurial journey from accidental discovery to startup founder. Her passion for solving this critical industry challenge exemplifies how scientists can transform technical innovations into practical solutions that benefit both industry and environment.

Whether you're a bioprocess scientist struggling with endotoxin testing, a quality assurance professional seeking more reliable methods, or someone interested in sustainable alternatives to animal-based testing, this episode provides a clear path toward a future where patient safety doesn't rely on horseshoe crab blood.

Listen now to discover how you can implement smarter endotoxin testing at your organization – and reach out to Anika via the links in our show notes if you want to be among the first to access this groundbreaking technology.

Connect with Anika Hoffmann:

LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/

Email: anika.hoffmann@hevs.ch

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/

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In biopharmaceutical manufacturing, endotoxins represent a silent but deadly threat – bacterial fragments capable of triggering severe immune responses at picogram levels, potentially leading to septic shock, organ failure, or even death in patients.

In this eye-opening first episode, we speak with Anika Hoffmann, a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland, who's challenging the decades-old status quo of endotoxin testing. For nearly 50 years, the industry has relied on horseshoe crab blood (LAL assay) despite its significant limitations and sustainability concerns.

Anika reveals the troubling truth about traditional testing methods:

• The LAL reliability problem: With acceptable recovery rates ranging from 50-200% and high variability, can we truly trust our current methods?
• The "low endotoxin recovery" phenomenon: How common pharmaceutical ingredients can mask dangerous endotoxins, creating false negatives
• The horseshoe crab sustainability crisis: Rising testing demand threatens declining horseshoe crab populations

Most importantly, Anika introduces her groundbreaking alternative: a chemical analytical method targeting KDO, a unique sugar molecule present in all endotoxins. This approach eliminates reliance on enzymes or animal products while providing more consistent results across different pharmaceutical formulations.

With regulatory limits as strict as 0.25 EU/mL for water for injection, reliable detection isn't just a quality issue – it's a patient safety imperative. If you're developing biologics, managing bioprocess quality, or navigating regulatory compliance, this episode reveals why rethinking endotoxin testing could be your most important decision.

Listen to Part 1 to discover why smarter endotoxin testing is possible without relying on horseshoe crab blood, and stay tuned for Part 2 where we'll explore the practical implementation of this revolutionary approach.

Connect with Anika Hoffmann:

LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/

Email: anika.hoffmann@hevs.ch

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/