The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.

Topics Include:

• The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.
• Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.
• The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.
• Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.
• A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.

Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.

📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.

Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape.

In this episode of Life Science Solutions, host Chris Adkins is joined by Andrea Arsiccio, PhD, Senior Scientist and Team Lead In Silico at Coriolis Pharma, to discuss how in silico modeling is revolutionizing the assessment of developability and formulation strategies for new drug products.

Andrea breaks down how Coriolis Pharma combines physics-based models and Artificial Intelligence with traditional wet lab experimentation to predict molecule behavior, identify liabilities early, and solve complex problems like aggregation and viscosity.

Topics Include:

• Defining In Silico: Understanding the spectrum from mechanistic models and molecular dynamics to AI and machine learning.
• Accelerating Development: How computational tools reduce the need for animal testing and save precious material in early-phase development.
• The "Why" Behind the "What": Using modeling to uncover the specific mechanisms causing instability or aggregation.
• The Hybrid Approach: Validating digital predictions with high-throughput wet lab screening for a robust formulation strategy.
• Regulatory Perspectives: How the FDA and EMA are viewing AI data and the importance of establishing model credibility.
• Expansion: Coriolis Pharma’s growth into the US market and their new capabilities in Research Triangle Park.

Whether you are a formulation scientist, a CMC leader, or a regulatory professional, this episode provides a fascinating look at how digital twins and computational strategies are de-risking the path to market for life-saving therapies.

📍Recorded at Kymanox HQ in Research Triangle Park, North Carolina.

#Biologics #InSilico #DrugDevelopment #FormulationScience #AIinPharma #CoriolisPharma #LifeSciences #Kymanox

Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.

In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards.

Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.

Topics Include:

• What design controls are and why they matter for medical devices and combination products.
• How AI is evolving from a personal tool to a professional asset in regulated environments.
• Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.
• Specific uses within Design Verification, including sample size determination and data analysis.
• Managing AI risks: why "hallucinations" happen and the need for expert human oversight.
• Sustainability considerations: could AI use impact environmental goals in MedTech?

Whether you’re a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.

📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.
#MedTech #AI #DesignControls #MedicalDevices #RegulatoryScience #LifeSciences

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

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 compliance
• The science of formulation: balancing potency, viscosity, and stability
• Scale-up and manufacturing barriers innovators must solve
• Lifecycle management and the competitive edge of delivery innovation

This 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

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 beyond

Gary 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 careers
• Why North Carolina has become a hub for biomanufacturing growth
• The rise of single-use technologies and what they mean for training and efficiency
• The importance of hands-on GMP experience for students and professionals alike

This 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

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 shift
• The labor and infrastructure gap in U.S. biologics manufacturing
• How CDMO specialization is reshaping the global pharma supply chain

From 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

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.