Life Science Solutions

Mechanical or Electromechanical? Designing for the User

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 devi

Reducing Risk in Injectable Drug Development Starts with Primary Packaging

Primary packaging is often treated as a late-stage procurement decision,  in reality, it can influence formulation stability, manufacturing, regulatory strategy, device p

De-Risking Early-Stage Formulation Development: Inside the Kymanox Lab

Every formulation decision made early in development carries downstream implications for stability, manufacturing, scalability, and analytical strategy. As therapies beco

GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery

The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As these treatments mature

Particles in Biologics: Advanced Analytics and Tech Transfer

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? Partic

What Successful CSV and CSA Teams Do Differently

For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But for many organizations,

Navigating a CDMO-Based CRL: From Crisis to Compliance

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 yo

5 Steps to Operationalizing FDA’s QMS

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 Silico Modeling: A Drug Developer's Superpower

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

Smarter Design Controls with AI - Is It Possible?

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

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 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 witho

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 resha

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 sup

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 A

The Blueprint for Science Marketing Success with Elizabeth Chabe

In this episode of Life Science Solutions, we’re joined by Elizabeth Chabe — author of The Giant’s Ladder and CEO of High Touch Group — to unpack one of the most underest

How Startups and Industry Support Each Other

In our latest Life Science Solutions podcast, we sit down with Lydia Thomas from UNCW’s Center for Innovation and Entrepreneurship to talk about the real-world gaps acade

Capturing Venture Capital: What Makes Life Science Startups Stand Out to Investors

In this special episode recorded live at CED Venture Connect, host Chris Adkins sits down with Dave Ousterout, Co-Founder and General Partner at CapeFear Biocapital. Draw

Manufacturing Intelligence for Bioprocessing

On this episode, host Chris Adkins speaks with Gerry Farrell, a seasoned expert with over two decades of experience in the CDMO space and current executive advisor at Kym

The ten23 health Approach to Biologics Development

How is ten23 health revolutionizing biologics drug delivery and CDMO services? In this episode, we sit down with Hans-Christian Mahler, Founder and CEO of ten23 health,