Beyond 200 mg/mL: The Science and Scaling of High-Dose Biologics
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 solutionsHow microparticle suspensions dissolve rapidly in vivo to avoid depot effectsRheology 101: viscosity curves, shear-thinning fluids, and device designThe shift to aseptic manufacturing when sterile filtration isn’t an optionPreclinical safety considerations and scaling studies from rodents to NHPsWhy early conversations with FDA’s Emerging Technology Program matterThis 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
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High Stakes, High Concentrations: Inside Biologics Innovation (Part 1)
In today’s pharma landscape, patient convenience and drug delivery innovation go hand in hand. But how do you deliver life-saving biologics at higher concentrations without sacrificing safety, stability, or patient comfort?In this live-recorded episode of Life Science Solutions, host Chris Adkins sits down with Ryan Doxey, Vice President of Technical Services at Kymanox, for part one of their conversation together. Ryan unpacks the opportunities and challenges of hyper-concentrated formulations, from why patients stand to benefit to how technical hurdles like viscosity, stability, and scale-up shape the path forward.Chris and Ryan dig into what makes high-concentration biologics both technically challenging and clinically promising.Topics Include:Why high-concentration biologics matter for patient convenience and complianceThe science of formulation: balancing potency, viscosity, and stabilityScale-up and manufacturing barriers innovators must solveLifecycle management and the competitive edge of delivery innovationThis is part one of a two-part conversation with Ryan Doxey, offering an inside look at how advanced biologics are being reimagined for the patients who need them most.📍 Recorded live during the Podcast Marathon at Walk West studio in Raleigh North Carolina.#Biologics #DrugDelivery #PharmaInnovation #CMC #LifeSciences
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Training Tomorrow’s Biopharma Workforce
As the biopharmaceutical industry expands, companies face a constant challenge: How do you find and train the talent needed to sustain growth? And how is technology reshaping the way we prepare the workforce?In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Gary Gilleskie, Executive Director of the Biomanufacturing Training and Education Center (BTEC) at NC State University. Together, they explore the evolution of biologics manufacturing in NC, BTEC’s hybrid industry-academia training model, and the center’s unique impact on workforce development in biopharma and beyondGary shares insights from decades of experience in both industry and education—from the early days of stainless-steel facilities to the rise of single-use technology, to today’s booming demand for GMP-trained professionals. Topics Include:How BTEC bridges academia and industry to prepare talent for biopharma careersWhy North Carolina has become a hub for biomanufacturing growthThe rise of single-use technologies and what they mean for training and efficiencyThe importance of hands-on GMP experience for students and professionals alikeThis episode highlights the strategies, infrastructure, and people driving innovation in biopharma—and why workforce development is the key to keeping pace with the industry’s future.#Biomanufacturing #Biopharma #GMP
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Is Onshoring Biomanufacturing Really Happening?
As pharmaceutical companies grow, they face critical choices: Where should you manufacture your product? How do you choose the right CDMO? What risks come with global supply chains?In this episode of Life Science Solutions, host Chris Adkins sits down with Roger Lias, PhD a 35-year veteran of the biologics manufacturing industry, to dig into the realities of onshoring in pharma and the evolving CDMO landscape.Roger walks through geopolitics and the BIOSECURE Act to the practical hurdles of talent shortages and infrastructure buildouts. Roger outlines what sponsor companies need to consider when choosing a domestic or international partner, from experience working in APAC. Topics include:Why “onshoring” may be more political theater than operational shiftThe labor and infrastructure gap in U.S. biologics manufacturingHow CDMO specialization is reshaping the global pharma supply chainFrom navigating regulatory risks to building smart tech transfer plans, this episode gives growing pharma teams the tools to make better decisions.📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.#Biomanufacturing #CDMO #Onshoring #LifeSciences #Biologics #PharmaManufacturing
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AI and the Future of Cancer Research
In this eye-opening episode of Life Science Solutions, Chris Adkins sits down with Marcel Frenkel, PhD, CEO and Co-Founder of Ten63 Therapeutics—a biotech startup using AI and quantum physics to design drugs for the most elusive and "undruggable" cancer targets.Marcel shares the groundbreaking science behind Ten63’s BEYOND platform, which navigates a chemical space of 10⁶³ possible molecules to find solutions the pharmaceutical industry previously considered impossible. With personal insight from his mother’s cancer journey, Frenkel explains how traditional drug discovery fails patients—and how Ten63 is flipping the script.Whether you're in biotech, pharma, or just passionate about the future of AI in medicine, this episode is a powerful look into the next frontier of oncology and therapeutic innovation.
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.
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