Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

Biologics development is full of hidden pitfalls, from selecting the right cell line to navigating analytical assessments that can make or break a therapy's success.
Today, we feature Lars Stöckl and Lena Tholen, industry experts from FyoniBio GmbH, who have deep experience guiding biotech teams through the maze of CMC development, troubleshooting both common and unusual product quality challenges.
Topics discussed:
Key factors in selecting host cell lines and the importance of matching the platform to molecule complexity (02:34)
The role of broad analytical assays early in cell line and pool development for better decision-making (03:34)
Glycosylation, post-translational modifications, and analytical strategies for both standard antibodies and more complex biotherapeutics (05:10)
When and how to conduct developability and manufacturability assessments, especially for novel or specialized molecules (06:55)
Troubleshooting glycosylation and aggregation problems—when to tweak the process and when to reconsider the molecule (08:05)
Importance of clear, direct communication with clients regarding manufacturability and process viability (09:32)
Example of how different CHO cell lines can dramatically impact molecule outcome and company trajectory (12:08)
Keeping pace with technological advances through collaboration, conferences, and feasibility studies with startups (13:55)
The move toward customization over standardization in cell line and process development (18:07)
Smart insight: The future of bioprocess development lies in a customized, molecule-centric approach. Rather than relying on generic, pre-set development platforms, success comes from carefully matching cell lines, processes, and analytical methods to the unique requirements of each molecule. True innovation and commercial success arise from adapting everything—cell line, process, analytics—to the molecule at hand.
Lars and Lena’s main point is that early choices about the host cell line, the analytics and the partner decide what’s possible later on. The episodes below take that idea further. One looks at the mechanics of cell line development, one at why promising molecules fail to manufacture, and two at outsourcing CMC work from the sponsor’s side.
Episodes 117 - 118: Cell Line Development Secrets: Eliminating Critical Bottlenecks for Faster Timelines with Andrea Gough
Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist’s Guide to CDMO Selection with Sigma Mostafa
Episodes 71 - 72: Effective Outsourcing: How Small Biotech Companies Can Thrive with Mark Melville
Connect with Lars Stöckl and Lena Tholen:
 Website: www.fyonibio.com
LinkedIn:www.linkedin.com/in/dr-lars-stoeckl
LinkedIn: www.linkedin.com/in/lena-tholen-80642a11a
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How can small biotech companies navigate increasing molecular complexity, tight budgets, and the ever-present pressure to accelerate timelines while ensuring long-term process success?
In this episode, David Brühlmann welcomes Lena Tholen and Lars Stöckl of FyoniBio GmbH—two scientists who’ve dedicated their careers to optimizing cell line and process development for biopharma clients.
Topics covered in this episode:
The trend toward outsourcing CMC development and the reasons behind it for both large pharma and small biotechs (07:27)
How specialized CDMOs innovate and continuously improve cell line development platforms, giving clients access to new options and efficiencies (10:36)
Real-world experience navigating project pitfalls from discovery to clinical studies—including differences between cell lines and processes (13:38)
The importance of retaining key activity assays and critical knowledge in-house—and the risks of over-reliance on consultants (15:04)
Key factors that help biotech companies thrive when partnering with CDMOs, including internal expertise, flexibility, and milestone planning (17:32)
Smart insight: Product quality and success are designed in early through careful choices about cell lines, processes, and analytical strategies. Streamlined outsourcing and platform innovation can turbocharge development, but only when matched with committed, knowledgeable in-house leadership and measured, forward-thinking investment. The next time a CMC decision seems minor or a shortcut tempting, remember the long game—your product quality, speed to clinic, and future cost may all depend on it.
Lars and Lena’s main point is that early choices about the host cell line, the analytics and the partner decide what’s possible later on. The episodes below take that idea further. One looks at the mechanics of cell line development, one at why promising molecules fail to manufacture, and two at outsourcing CMC work from the sponsor’s side.
Episodes 117 - 118: Cell Line Development Secrets: Eliminating Critical Bottlenecks for Faster Timelines with Andrea Gough
Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist’s Guide to CDMO Selection with Sigma Mostafa
Episodes 71 - 72: Effective Outsourcing: How Small Biotech Companies Can Thrive with Mark Melville
Connect with Lars Stöckl and Lena Tholen:
 Website: www.fyonibio.com
LinkedIn:www.linkedin.com/in/dr-lars-stoeckl
LinkedIn: www.linkedin.com/in/lena-tholen-80642a11a
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Is your process model gathering dust while real-world decisions march on without it? Many technically strong digital tools—no matter how powerful—end up sidelined in bioprocess development. Why is that, and what does it actually take for digital modeling to earn its place at the lab bench?
In this episode, David Brühlmann sits down with Moritz von Stosch of HINA Bioventures, a scientist-turned-investor who’s navigated both the technology provider and pharma end-user sides. Moritz von Stosch brings firsthand insights from building digital solutions, deploying them in pharma, and evaluating what actually sticks when the clock is ticking and the stakes are high.
Topics discussed:
The importance of starting with your purpose when selecting a modeling strategy (03:00)
Experimental design: when to use factorial versus random space-filling designs, and the inherent biases each can introduce (04:22)
The future of agentic workflows, AI, and autonomous labs in bioprocessing, including the importance and challenges of sensor technologies (06:02)
Practical hurdles to implementing fully autonomous laboratories, and the non-obvious value humans still bring (09:09)
Adapting mindsets for the evolving role of the bioprocess engineer in a more automated, agent-driven workflow (11:48)
Advice for biotech professionals on how to assess the real value in new technologies versus hype, and the role of proprietary algorithms and company stability (13:33)
How cultural factors, not just technology, shape the adoption of modeling and digital tools in biotech (16:02)
Strategies to help the bioprocess community adopt more innovation while ensuring compliance in regulated environments (17:14)
Three key takeaways for staying relevant—including generating data for tomorrow’s questions and balancing curiosity, experimentation, and oversight (19:14)
Smart insight: Three takeaways from Moritz von Stosch:
Generate data for tomorrow’s questions, not just today’s.
Be curious—try, adapt, don’t over-plan.
Stay relevant: Use digital tools but keep your human edge (creativity, critical thinking).
To keep exploring how modeling and prior knowledge can speed up process development, check out these related conversations:
Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey
Episodes 277 - 278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano
Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov
Connect with Moritz von Stosch:
 Website: www.hinabioventures.com
LinkedIn: www.linkedin.com/in/movosto
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Are you frustrated with reinventing the wheel every time a new molecule enters bioprocess development? Is there a better way to harness data and modeling to accelerate breakthroughs in biotech? The bioprocessing industry is constantly searching for ways to streamline development, reduce costs, and speed new therapies to market—yet leveraging existing knowledge remains a significant challenge.
In this episode, David Brühlmann welcomes Moritz von Stosch, partner at HINA Bioventures and a pioneer in digital bioprocess development. Spanning roles from academic research in hybrid modeling to solution design at DataHow and now biotech investment, Moritz von Stosch’s journey traces how mechanistic, hybrid, and machine learning models have (and haven’t) changed process development over the last two decades.
Topics discussed:
Moritz von Stosch’s career: from early interest in modeling to investment in digital bioprocess tools (03:36)
The reality and limitations of platformization and knowledge reuse in large pharma (07:37)
Historical context and effectiveness of QbD (Quality by Design) and PAT (Process Analytical Technology) initiatives (10:24)
Where modeling can reliably deliver value today in process and clinical development—and where it still overpromises (12:17)
The importance of starting to build models early and collecting data that can be reused and repurposed across the process lifecycle (14:17)
Approaches to transferring learning between molecules, cell lines, platforms, and the fundamental limitations of this transfer (16:40)
Opportunities and difficulties in transferring process knowledge across scales (from microtiter plates to large bioreactors) (18:31)
Smart insight: David Brühlmann and Moritz von Stosch agree that models are only useful when they are built on reliable data and interpreted with expert judgment. Models can help biotech teams make better decisions, but they don’t replace human expertise. The real value comes from looking at the whole process, focusing on the data that matters, and making sure knowledge is shared effectively. This can help teams improve bioprocess development and bring new treatments to patients sooner.
To keep exploring how modeling and prior knowledge can speed up process development, check out these related conversations:
Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey
Episodes 277 - 278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano
Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov
Connect with Moritz von Stosch:
 Website: www.hinabioventures.com
LinkedIn: www.linkedin.com/in/movosto
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The entire public record of antibody affinity data comes to about half a million measurements, and by David Younger's estimate, upwards of 75% of it is AlphaSeq data from his own company's publications. His conclusion is that no single company can close the gap alone. So he is asking pharma and AI labs to pay for an experiment and share every result with the other members.
In Part 2 of this two-part conversation, David Brühlmann talks with Younger, founding CEO of A-Alpha Bio, whose AlphaSeq platform uses engineered yeast to measure protein interactions at scale. Part 1 set out the shortfall: about 10,000 antibody-antigen structures in the Protein Data Bank against a need of hundreds of thousands to millions. Here Younger explains how the consortium keeps proprietary targets out of the shared pool, who has joined, and why he believes it differs from federated learning.
Topics discussed:
Challenges faced by individual companies in generating sufficient data for effective AI models (02:17)
How a data consortium enables pre-competitive data sharing while protecting proprietary information (06:13)
Profiles of ideal consortium members and examples of current participants from pharma and AI model builders (08:36)
The consortium’s current focus on VHH antibodies and plans for expansion to broader datasets and applications by 2030 (10:00)
Comparison between the consortium approach and federated learning models in data sharing and collaboration (12:01)
The main takeaways about the quantity and quality of data needed for machine learning in protein engineering (14:09)
Smart insight: As David Younger envisions it, successful maturation of these consortia could fundamentally shift the field by 2030. Multiple consortia could address different scaffolds, data types, and problem statements, alleviating the bottleneck that has long constrained progress. The hope is that abundant, high-quality data will enable breakthrough therapeutic advancements while revealing new gaps that, in turn, inspire the next wave of innovation. Notably, David Younger sees collaboration—not just data scale—as the true secret weapon. Unlike federated learning, consortia incentivize members to share not just data, but experimental insights and best practices, effectively lifting all boats and accelerating collective progress.
Curious how others are tackling the data problem in protein design? These episodes pick up right where David Younger leaves off.
Episodes 185 - 186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus
Episodes 115 - 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti
Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
Episodes 219 - 220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger
Connect with David Younger
 Company website: www.aalphabio.com
LinkedIn: www.linkedin.com/in/david-a-younger/
Data Atlas website: www.atlas.aalphabio.com
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