Pushing biologics beyond 200 mg/mL isn’t just a formulation challenge - it’s a delivery, manufacturing, and regulatory challenge too. Aggregation, precipitation, and sky-high viscosity make scaling these therapies a gauntlet for drug developers.
In this episode of Life Science Solutions, host Chris Adkins continues the conversation on hyper-concentrated biologics with Ryan Doxey, VP of Tech Ops & CMC at Kymanox, and Nick Letourneau, PhD, Associate Director of Product Development & Commercialization. Together, they unpack how dehydrated protein microparticles suspended in hydrophobic carriers (like MCT oils or ethyl oleate) can dissolve instantly upon injection, and why this breakthrough could dramatically ease the patient experience.
The conversation dives deep into what this means for manufacturing, device compatibility, and regulatory pathways, revealing how the future of injectables depends on solving problems once thought unsolvable.
Topics include:
- Why ultra-concentrated biologics often fail in aqueous solutions
- How microparticle suspensions dissolve rapidly in vivo to avoid depot effects
- Rheology 101: viscosity curves, shear-thinning fluids, and device design
- The shift to aseptic manufacturing when sterile filtration isn’t an option
- Preclinical safety considerations and scaling studies from rodents to NHPs
- Why early conversations with FDA’s Emerging Technology Program matter
This is part two of our deep dive on concentrated biologics - picking up where our Podcast Marathon live episode left off. This episode offers a rare look inside the formulation frontier — where drug science, delivery design, and patient experience intersect.
📍Recorded at the Kymanox studio in Research Triangle Park, North Carolina.
#Biologics #DrugDelivery #Autoinjectors #Rheology #GMP #PharmaInnovation
What is Life Science Solutions?
Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility.