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Life Science Solutions

Kymanox
Artificial Intelligence
Hyper-Concentrated Formulations
Biomanufacturing Education and Training Center
Computer System Validation
Computer Software Assurance
Monoclonal Antibodies
Biopharmaceuticals
Design Controls
Biologics
Particle Analytics
Ten63 Therapeutics
CDMO
North Carolina
FDA
Data Analysis
Documentation
In Silico Modeling
Drug Development
GAMP 5
Technology Transfer

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... more

PublishesMonthlyEpisodes45Founded4 years ago
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Latest Episodes

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 stabilit... more

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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... more

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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 laye... more

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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 j... more

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Recent Guests

Tim Menzen
Chief Technology Officer
Coriolis Pharma
Episode: Particles in Biologics: Advanced Analytics and Tech Transfer
Tara Doby
Validation strategy, compliance, and regulated digital systems
Kymanox
Episode: What Successful CSV and CSA Teams Do Differently
David Dlugo
Senior Director of Quality at Kymanox
Kymanox
Episode: 5 Steps to Operationalizing FDA’s QMS
Andrea Arsiccio
Senior Scientist and Team Lead in Silico at Coriolis Pharma
Coriolis Pharma
Episode: In Silico Modeling: A Drug Developer's Superpower
Nick Ciccarelli
Chief Technology Officer
Kymanox
Episode: Smarter Design Controls with AI - Is It Possible?
Ryan Doxey
Vice President of Technical Solutions at Kymanox
Kymanox
Episode: High Stakes, High Concentrations: Inside Biologics Innovation (Part 1)
Gary Gilleskie
Director, Golden Leaf Biomanufacturing Training and Education Center (BTEC) at NC State
NC State University, Biomanufacturing Training and Education Center (BTEC)
Episode: Training Tomorrow’s Biopharma Workforce
Roger Lias
Expert in biologics manufacturing and CDMO space
Kymanox
Episode: Is Onshoring Biomanufacturing Really Happening?
Marcel Frenkel
CEO and co-founder of Ten63 Therapeutics
Ten63 Therapeutics
Episode: AI and the Future of Cancer Research

Host

Chris Adkins
Host of Life Science Solutions

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In Silico Modeling: A Drug Developer's Superpower
Q: Can you share a specific example where in silico modeling helped resolve a formulation or process challenge?
A notable example involved a molecule showing significant aggregation and instability. By comparing the molecule to databases of approved compounds, in silico tools pinpointed a mechanism behind the aggregation, enabling targeted formulation strategies to mitigate the issue rather than relying solely on empirical trial-and-error approaches.
In Silico Modeling: A Drug Developer's Superpower
Q: How do you blend computational models with experimental data in Coriolis's workflow?
The workflow starts with extensive model development and credibility validation in silico, then uses the model to reduce wet-lab experiments. Once credibility and extrapolation capabilities are established, the model helps focus experiments, guiding testing on the most informative variables and ensuring the data informs both formulation and manufacturing decisions.
In Silico Modeling: A Drug Developer's Superpower
Q: What does in silico modeling mean in the context of drug development and why is it becoming important for biologics and advanced therapies?
In silico modeling encompasses computer-based calculations and models, including mechanistic, AI-driven, and physics-based approaches, used to support drug development by screening candidates, assessing developability, and guiding formulation. Its growing importance comes from speeding development, reducing animal testing, and enabling smarter decision-making early in the pipeline, especially for complex biologics where traditional lab work is costly or limited.
Particles in Biologics: Advanced Analytics and Tech Transfer
Q: How do advances in particle analytics impact technology transfer decisions?
Advanced analytics provide a more nuanced understanding of particle origins and mechanisms, enabling targeted decisions on formulation, packaging, and process design to mitigate risks before transfer, which can shorten timelines and improve regulatory readiness.
Particles in Biologics: Advanced Analytics and Tech Transfer
Q: What trends are you seeing in development and manufacturing challenges for biologics?
The shift is toward more predictive science and digital tooling, enabling earlier identification of risks, better understanding of particle formation across the lifecycle, and smoother tech transfers through deeper, data-driven comparability.

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Frequently Asked Questions About Life Science Solutions

What is Life Science Solutions about and what kind of topics does it cover?

Across multiple episodes, the show explores practical challenges and rapid advances in biopharma, medtech, and life sciences—from deep science topics like particle analytics, in silico modeling, and high-concentration biologics to regulatory shifts such as CSA adoption, QMSR implementation, and ISO alignment. Conversations frequently pair hands-on technical depth with pragmatic pathways for teams: how to transfer processes between sites, validate in regulated environments, and accelerate development with AI and digital tools. A standout thread is the emphasis on real-world applicability—shared by guests from industry and academia—covering manufacturing scalability, workforce development, and market-ready strategies for startups and sponsors... more

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1. Up First from NPR

How many episodes of Life Science Solutions are there?

Life Science Solutions launched 4 years ago and published 45 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Life Science Solutions?

Recent guests on Life Science Solutions include:

1. Tim Menzen
2. Tara Doby
3. David Dlugo
4. Andrea Arsiccio
5. Nick Ciccarelli
6. Ryan Doxey
7. Gary Gilleskie
8. Roger Lias

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