Life Science Solutions

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.
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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.
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📍 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.