Life Science Solutions

To err is human. To make things up is AI. So in a regulated industry, how should the two work together?

In this episode, host Chris Adkins talks with David Dlugo, Senior Director of Quality Assurance at Kymanox, about using AI responsibly in a regulated industry. David explains why every AI output at Kymanox gets reviewed by a seasoned expert. He also walks through a “two-part authentication” approach, where an AI review and a human review are checked against each other. And he shares where AI saves real time in SOP drafting, and where it saves none.

They also cover:

• Where AI fits in quality work today: QMS, batch record review, CAPAs, deviations, and complaint handling
• Why the bot should never make the call in quality decisions
• What changes for the people doing the work, and what doesn’t
• How to vet AI vendors when everyone is promising the world

Presented by Kymanox. Produced by Walk West.

Episode Description:

Most drug delivery devices are mechanical by default: a spring, a click, a color that shifts from yellow to green. As drug delivery and medical devices become more complex, electromechanical engineering is opening new possibilities for functionality, usability, feedback, and patient experience.

In this episode of Life Science Solutions, Chris Adkins talks with Andrew King about what goes into developing electromechanical devices, from the early concept through prototyping, testing, and formal development.  Andrew brings hands-on experience designing drug delivery systems where mechanics, electronics, software, sensors, and controls all have to work as one.

Topics Include:

• Mechanical vs. Electromechanical: What actually makes a device electromechanical (electronics core to the function, not a sensor bolted on), and why that distinction shapes how a team is built.
• The Case for Complexity: Why teams move past off-the-shelf mechanical devices, driven by adherence gaps, patient discomfort, and physical or cognitive impairment.
• Devices That Communicate: How electromechanical systems replace ambiguous clicks and color changes with speech, imagery, animations, tones, and haptics.
• When Simpler Means Electromechanical: A multi-dose, needle-indexing project that went from an over-complicated mechanical design to a simpler, cheaper, more capable electromechanical one in days.
• Decisions, Not Features: Why the real risk is analysis paralysis, and how an experienced team helps a project recognize when good is good enough.
• Prototype to Formal Development: How to tell when a prototype is ready for design controls, and why failing a DV test should come as a surprise.
• Purposeful Complexity and Sustainability: The shift from Cadillac halo products to solving real use-case problems, plus multi-use devices that reduce waste per dose.

How much complexity does a device actually need? Take a listen to hear from our experts. 

🎧 Subscribe to Life Science Solutions for more conversations about the science, engineering, technology, quality, and regulatory considerations shaping the life sciences industry. 

Primary packaging is often treated as a late-stage procurement decision,  in reality, it can influence formulation stability, manufacturing, regulatory strategy, device performance, and ultimately how quickly a therapy reaches patients.

In this episode of Life Science Solutions, host Chris Adkins sits down with Katie Falcone, Director of Technical Services for Integrated Systems at West Pharmaceutical Services. Katie draws on her decade of primary packaging experience to explain why drug developers (especially lean, emerging biotechs) need to integrate primary packaging decisions into early pre-formulation work rather than treating it as a late-stage commodity purchase.

Together, they dive into the technical nuances of parenteral packaging and explore how integrated platforms - like the West Synchrony™ system - are replacing the traditional, fragmented supplier model to significantly de-risk and speed up time-to-clinic.

Topics Include:

• Vials vs. Dynamic Systems: How transitioning from static vials to pre-filled syringes introduces dynamic functional forces (break loose/glide force), ISO device standards, and combination product complexities.
• The "Three-Headed Monster": The headaches drug sponsors face when attempting to stitch together specifications, extractables/leachables data, and Drug Master Files (DMFs) from three separate component suppliers.
• Integrated Platforms: How pre-tested, single-source platforms offer two years of aged drug-independent data, complete DMF files, and copy-and-paste regulatory packages for EU Notified Bodies.
• Early Technical Nuances: Why critical decisions around gas ingress, silicone oil specs, container closure integrity (CCI), and needle gauge vs. viscosity directly dictate patient comfort and auto-injector performance.
• Fill/Finish & CDMO Alignment: Ensuring that packaging selections align with commercial fill/finish line mechanics, coefficients of friction, and CDMO capabilities early to prevent costly launch delays.
• The Shift to At-Home Care: Supporting the growing industry push toward high-volume, high-viscosity subcutaneous injections that empower patients to manage complex therapies at home.

Whether you are formulating a sensitive biologic or preparing your first combination product submission, this conversation provides a clear blueprint for selecting the right primary packaging from day one.

🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your formulation, quality, and CMC teams!

Every formulation decision made early in development carries downstream implications for stability, manufacturing, scalability, and analytical strategy. As therapies become more complex and development timelines compress, getting formulation right from the start has never mattered more.

In this episode of Life Science Solutions, host Chris Adkins sits down with Kymanox experts Ryan Doxey, VP of Technical Services, and Matt Owen, PhD Associate Director of CMC and Pharmaceutical Sciences. Together, they introduce the newly announced Kymanox Formulation Lab and discuss why having dedicated wet lab space is essential for true IND-enabling formulation development.

While Contract Development and Manufacturing Organizations (CDMOs) are built for throughput and execution, they are typically not staffed or equipped to troubleshoot complex scientific issues. This episode explores how applying a "science driving success" approach early on bridges that gap and ensures that your clinical manufacturing timelines stay on track.

Topics Include:

• The CDMO Bottleneck: Why contract manufacturers lack the agility to spend adequate time developing formulations, and how unsolved early issues cause costly delays in Phase 1 and Phase 2 clinical manufacturing.
• Quality by Design (QbD): Why developing a product merely to meet a Certificate of Analysis (CFA) is insufficient, and the importance of truly understanding your design space to inherently ensure a quality product.
• Real-World Case Studies: How unknown peaks during forced degradation/leachable studies can derail timelines, and why understanding complex interactions like heat-catalyzed oxidation is crucial before scaling up.
• Advanced Characterization: Why CDMOs often skip critical tests like permeation and mucus adhesion studies, and how using tools like nasal cast models ensures an intranasal product has adequate residence time and efficacy.
• Future Trends: The push for biologics and the resurgence of spray-dried formulations to improve global storage conditions, especially as standard injection vehicles struggle to handle the viscosity of high-concentration antibodies.

Taking a thoughtful, science-driven approach to early formulation can help reduce risk and avoid costly development delays.

🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your formulation, quality, and device engineering teams!

The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As these treatments mature and reach millions of patients, the pharmaceutical industry is being forced to rethink dose volumes, supply chain sustainability, and device design.

In this episode of Life Science Solutions, host Chris Adkins sits down with Paul Jansen, a recognized industry voice and veteran leader in medical device development and combination products. Drawing from his extensive background, including leadership roles at Sanofi, Paul explains how the massive success of GLP-1 therapies is shaking up the industry and forcing innovators to adapt.

Topics Include:

• The GLP-1 Ripple Effect: Why the current model of one injection per device is environmentally and economically unsustainable for mass markets, driving the shift toward fixed-dose pens and the future of auto-indexing needles.
• The Rise of Dual Chamber Systems: How the expiration of key patents is opening the door for dual chamber cartridges, allowing for easier lyophilization reconstitution and the sequential delivery of complex, mixed therapies.
• Wearable Injectors: Why on-body wearables haven't hit their predicted "hockey stick" growth yet, and why the industry needs to focus on creating affordable, less-featured baseline devices rather than over-engineering them.
• The Reality of Connected Devices: Why smart connectivity provides massive value for highly motivated patients (such as those undergoing fertility or oncology treatments), but still lacks a clear value proposition for broader populations.
• Platform Innovation: The critical need for device companies to build adaptable technology platforms, collaborate closely with pharma, and integrate patient-centric usability engineering right from the start.

Stay up to date on industry trends as this conversation offers a clear roadmap for the future of combination products.

🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your formulation, quality, and device engineering teams!

For many teams, particles and aggregates are treated as a late-stage compliance headache or a sudden fire drill during manufacturing. But what if we looked closer? Particle populations can actually reveal deep insights about your formulation stability, process robustness, and potential technology transfer risks long before you reach commercial scale.

In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Tim Menzen, Chief Technology Officer at Coriolis Pharma, a science-driven CRO specializing in formulation development and advanced analytics for biopharmaceuticals. With a PhD focused on the thermal unfolding and aggregation of monoclonal antibodies, Tim brings a wealth of expertise to the evolving landscape of biologic particles.

If your organization is looking to modernize how it approaches formulation and process development, this conversation is packed with cutting-edge insights.

Topics Include:

• The Evolution of Antibodies: How improved molecular engineering has shifted the industry away from from-scratch formulation and toward streamlined "formulability assessments".
• Tech Transfer Risks: Why pumps are famously considered "particle generating machines," and why true like-for-like process transfers rarely exist.Subvisible vs. Visible: Why waiting for visual particles is like ignoring a flashing red light, and how characterizing submicron particles early helps identify root causes.
• Orthogonal Analytics: Moving beyond traditional pharmacopeia methods (like sizing and counting) to determine exact particle morphology, such as distinguishing a silicone oil droplet from a fluffy protein aggregate.
• Particle Fingerprinting: How flow imaging microscopy and AI are being used to create two-dimensional "fingerprints" to compare the morphological density of particles across different processes.
• The Future of Formulation: What’s next on the horizon, including in silico computer simulations, multi-dimensional data instruments, and assay miniaturization to save valuable drug material.

This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.

🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your quality, validation, and IT teams!

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

For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But for many organizations, it has also become slow, expensive, and overloaded with documentation that does little to improve patient safety or data integrity.

In this episode of Life Science Solutions, host Chris Adkins sits down with Tara Doby, PMP, Manager of Technical Services at Kymanox, to unpack the industry's much-needed transition from traditional CSV to Computer Software Assurance (CSA). Tara explains how CSA utilizes the familiar GAMP 5 risk-based methodology, but strategically reduces the burden of step-by-step scripting for low-risk systems.

If your team is still validating systems simply because “that’s how it’s always been done,” this conversation will help you rethink your approach.

Topics Include:

• The CSA Mindset Shift: Why CSA isn't necessarily "less work," but rather a strategic refocusing of attention onto areas with the highest risk to product quality and patient safety.
• Unscripted vs. Undocumented: How to leverage knowledgeable Subject Matter Experts (SMEs) for unscripted testing without falling into the trap of failing to document the testing.
• Organizational Pitfalls: Why siloing your CSV efforts into a separate department often leads to redundant work, stepping on toes, and severely overburdening your Quality Assurance (QA) team.
• The Future of Validation: The growing necessity of leaning on vendors as subject matter experts, adopting a "trust but verify" approach to vendor testing, and the critical importance of robust vendor onboarding.
• Taking the First Step: Practical advice for introducing CSA principles, starting with stakeholder conversations and avoiding the conservative trap of labeling every single item as "high risk".

This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.

🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your quality, validation, and IT teams!

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

Dealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a failed inspection at your Contract Development and Manufacturing Organization (CDMO) adds a unique layer of business and operational complexity.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo (Senior Director of Quality at Kymanox) and Anthony Stewart (Senior Process Engineer at Kymanox) to dissect a real-world case study of remediation and return to GMP manufacturing following a failed Pre-Approval Inspection (PAI).

The team explores how to navigate the delicate balance between a Sponsor’s need for oversight and a CDMO’s need to protect proprietary operations, often using a "middleman" strategy to diffuse tension and accelerate compliance.

Topics Include:

• The "Survival Mode" Dynamic: Understanding the friction between a Sponsor’s urgency and a CDMO’s competing resource demands.
• Common Technical Pitfalls: Why "basic GMPs" and process control strategies (like Annex 1/contamination control) are frequent stumbling blocks during first-time inspections.
• The Power of Generalists: Why deploying a team of deep, diverse experts is more effective than just "throwing bodies" at a remediation project.
• 6 Keys to Success: David shares six essential steps to prevent CRLs, including robust supplier qualification and monthly governance meetings.
• Ideal Knowledge Transfer: How to leave the CDMO better than you found it by mentoring staff and improving quality systems for the long haul.

Whether you are navigating a current regulatory hurdle or preparing for your first BLA, this conversation offers a strategic roadmap for turning regulatory complexity into clarity.

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.

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