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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!
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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 2
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
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