For generations, silkworm pupae were discarded as waste from silk production. Now, KAICO is proving these organisms can function as highly efficient protein factories—producing complex vaccine antigens at yields and costs that challenge conventional bioreactor-based manufacturing. With a PCV2 oral vaccine already registered in Vietnam and a human norovirus vaccine preparing for Phase I clinical trials, the silkworm platform is moving from proof-of-concept to commercial reality.

In Part 2, Masafumi Osawa, Business Development Lead at KAICO, walks us through the company's product pipeline, the regulatory landscape for this unprecedented platform, and why silkworm-based manufacturing could reshape global vaccine accessibility. From farm-scale validation to regulatory dialogue with Japan's PMDA, this episode bridges platform science with product development.

Stops along our Silk Road to biomanufacturing

• KAICO’s approach to expressing complex proteins, including oral and injectable vaccines for animals and clinical-stage human health products (00:40)
• Immune-enhancing feed additive for pigs against PCV2 (registered in Vietnam), companion animal products, and human norovirus vaccine entering Phase 1 trials (02:50)
• Advantages of silkworm-produced antigens for both injectable and oral vaccines, and comparison to plant-based systems (04:57)
• How silkworm production enables rapid scale-out and high-yield protein expression for global accessibility (05:34)
• Speed of vaccine development with the silkworm platform—example with SARS-CoV-2 recombinant protein produced in three months (08:08)
• Key regulatory differences between animal and human vaccine development, including country-specific classification and global harmonization efforts (09:14)
• Sustainability and distributed manufacturing potential of silkworm-based systems (11:10)
• Milestones toward the first human biologic produced in silkworms, with phase 1 trials starting soon (12:27)
• Protein yield per silkworm pupae—scalability advantages compared to conventional bioreactor approaches (14:04)
• Masafumi Osawa’s thoughts on the future of silkworm-based biologics: from democratized therapies to personalized medicines (15:15)

Want to know if silkworms can solve your tough protein expression problems? Tune in now to learn how KAICO’s biotech is set to redefine what’s possible for vaccine development, and how their distributed, cost-effective approach could open doors across sectors.

Connect with Masafumi Osawa,:

LinkedIn: www.linkedin.com/in/masa-osawa

KAICO Ltd.: www.kaicoltd.jp/en

Next step:

Need fast CMC guidance? → Get rapid CMC decision support here

Support the show

For over 4,000 years, silkworms have connected civilizations through ancient trade routes. Now, KAICO Ltd., a Japanese biotech spin-off from Kyushu University, is transforming these creatures into living bioreactors capable of producing complex recombinant proteins and vaccine antigens—without the bioreactors, expensive media, or massive water consumption of conventional platforms.

Masafumi Osawa, Business Development Lead at KAICO, brings an unconventional path to biotech. Trained in cultural anthropology with fieldwork experience in Indonesia, he witnessed firsthand the healthcare disparities that drive his current mission. After years in pharmaceutical business development at Towa Pharmaceutical, he joined KAICO to help scale a technology he believes could reshape global vaccine accessibility. His cross-cultural expertise now proves invaluable as KAICO expands internationally, with active partnerships in Vietnam and Thailand and growing interest from other regions.

Episode highlights:

• Masafumi’s transition from anthropology to biotech, and how cross-cultural expertise benefits global health collaborations. (04:15)
• The founding story of KAICO, spun out from Kyushu University and focused on recombinant proteins and vaccine antigen production (08:45)
• Step-by-step overview of the silkworm baculovirus expression system, including pupae handling and bioprocessing basics. (10:28)
• Practical differences between silkworms, E. coli, mammalian, and insect cell culture platforms—exploring advantages and drawbacks. (13:10)
• Strategies KAICO uses to control silkworm variability, including SPF grade sourcing, diet, environment, and documentation for pharmaceutical acceptance. (15:08)
• Production scalability: a single pupa can match 100–1000 ml of insect cell culture, with major implications for cost and environmental footprint. (16:42)
• Downstream harvesting and purification—how KAICO extracts and processes proteins from silkworm pupae, keeping methods largely familiar to traditional systems. (19:31)
• Regulatory and GMP challenges of using live organisms, and KAICO’s approach to satisfying authorities and ensuring product consistency. (21:43)

Whether you’re curious about alternative biomanufacturing methods or want a transparent look at silkworm-based protein expression from research to the clinic, this episode delivers practical insights and thoughtful discussion.

Connect with Masafumi Osawa:

LinkedIn: www.linkedin.com/in/masa-osawa

KAICO Ltd.: www.kaicoltd.jp/en

Next step:

Need fast CMC guidance? → Get rapid CMC decision support here

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.

Support the show

Biomanufacturing has always dealt with the challenge of turning vast, complex datasets and intricate production steps into life-changing therapies. But when batch records multiply and process deviations loom, how do biotech teams make sense of it all? In this episode, we move beyond theory to the nuts and bolts of how AI - when thoughtfully deployed - can turn bioprocessing chaos into actionable intelligence, paving the way for the factory of the future.

Our guest, Ilya Burkov, Global Head of Healthcare and Life Sciences Growth at Nebius AI, doesn’t just talk about data wrangling and algorithms—he’s spent years building tools and strategies to help scientists organize, contextualize, and leverage real-world datasets. Having worked across tech innovation and pharmaceuticals, Ilya Burkov bridges cutting-edge computation with the practical realities of CMC development and manufacturing, making him a trusted voice on how bioprocessing is rapidly changing.

Highlights from the episode:

• Advice for biotech scientists on learning from innovations in other industries (00:02:21)
• Tackling the complexities of organizing huge and often unstructured datasets in bioprocessing (03:08)
• Techniques and tools to structure, label, and prepare data for AI—including Nebius’s in-house tool, Tracto AI (06:24)
• Strategies for startups and small teams—how to begin implementing AI and what areas of bioprocessing to focus on first (10:12)
• The vision for the “factory of the future”: AI-driven, interconnected, and self-learning manufacturing environments (08:11)
• Navigating the decision between on-premise and cloud computing for scalable, cost-effective AI workloads (12:32)
• The importance of partnership between scientists and AI, emphasizing collaboration and data-driven decisions (00:15:47)

Wondering how to kick off your own AI-enabled bioprocessing project, or what to insource versus outsource as you scale? This episode gives you a grounded starting point—minus the buzzwords and empty promises.

Connect with Ilya Burkov:

LinkedIn: www.linkedin.com/in/ilyaburkov

Contact email: ilya.burkov@nebius.com

Nebius: www.nebius.com

If this topic grabbed you, you'll love these related episodes focusing on advanced modeling, continuous manufacturing, and Digital Twins

• Episodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari
• Episodes 85 - 86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli
• Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
• Episode 153 - 154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos
• Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey

Next step:

Need fast CMC guidance? → Get rapid CMC decision support here

Support the show