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Artwork for Off Script: A Pharma Manufacturing Podcast

Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturing
FDA
Continuous Manufacturing
Cell and Gene Therapy
Artificial Intelligence
Automation
Robotics
Autologous Cell Therapy
CTMC
Drug Development
CDMO
Rockwell Automation
Annex 1
API Innovation Center
Generic Medicines
Association For Accessible Medicines
Antibody Drug Conjugates
Neuland Laboratories
Chloramines
Ultraviolet (UV) Technology
Peptide Development

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!

PublishesWeeklyEpisodes133Founded6 years ago
Number of ListenersCategories
NewsBusiness News

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Artwork for Off Script: A Pharma Manufacturing Podcast

Latest Episodes

The FDA recently announced the participants in its PreCheck pilot program, an initiative designed to encourage earlier collaboration between regulators and companies developing new domestic pharmaceutical manufacturing facilities. By shifting facilit... more

As pharmaceutical manufacturers work to reduce energy consumption and meet sustainability targets, attention is expanding beyond core production processes to the utility systems that support manufacturing. Steam systems, which play a critical role in... more

The advancement of pharmaceutical manufacturing depends heavily on the research taking place in areas such as continuous manufacturing, automation, machine learning, and AI. The maturation of these technologies will foster improved process optimizati... more

The framework of modern pharmaceutical manufacturing is evolving as new technologies, advanced therapeutic modalities, and more sophisticated process control reshape how medicines are developed. While biologics, peptides, and other emerging therapies... more

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Recent Guests

Dr. Thomas Roper
Co-Director of Pharmaceutical Engineering at Virginia Commonwealth University's Center for Pharmaceutical Engineering and Sciences; Graduate Program Director for Chemical and Life Science Engineering
Virginia Commonwealth University
Episode: How the Framework of Modern Pharma Manufacturing Is Being Rebuilt: Part One
Jim Masso
President and CEO of Honeywell Process Automation
Honeywell Process Automation
Episode: Accelerating Biopharma Manufacturing Through Integrated Automation
Jeff Mason
VP and Head of the New Jersey Sales Office at Samsung Biologics
Samsung Biologics
Episode: The Future of Global Biopharma Manufacturing Networks
Sebastián Arana
Executive Vice President and Global Head of Process Solutions
MilliporeSigma
Episode: Building Flexibility into Biopharma Manufacturing
David Thaisrivongs
Executive Director, Head of Biocatalysis at Merck
Merck
Episode: How Biocatalysis Is Changing Pharma Manufacturing
Dr. Sharad Kotturi
Chief Scientific Officer
Neuland Laboratories
Episode: How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part Two
Sharad Kotturi
Chief Scientific Officer
Neuland Laboratories
Episode: How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part One
Wayne Lem
Global Applications Manager for Trojan Technologies
Trojan Technologies
Episode: Solutions Spotlight: Managing Chloramines in Pharmaceutical Water Systems
David Leroux-Petersen
CEO of Corealis Pharma
Corealis Pharma
Episode: Can CDMO-to-CDMO Collaboration Simplify Drug Development?

Host

Andy Lundeen
Host of Off Script with a focus on pharma manufacturing and industry coverage.

Reviews

4.7 out of 5 stars from 13 ratings
  • An informative gem!

    Just discovered them through the schizophrenia episode and I’m so glad I did. A fresh, straightword and informative podcast. Perfect for those who want to learn about the latest insights of the industry in a concise manner.

    Apple Podcasts
    5
    hellomaleny
    United States2 years ago
  • Great Show!

    A total gem in Pharma Industry! Very knowledgeable and informative, the hosts and guests provides real insights that definitely work. Glad to find your podcast, I'm learning a lot!

    Apple Podcasts
    5
    Retchelle_Platforce
    Philippines4 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Guests and hosts are praised for real-world insights and practical discussions that translate to action.
Listeners describe the show as informative and concise, with clear takeaways for the pharma industry.
Praise for depth and breadth of topics, from policy to cutting-edge manufacturing technologies.
The content is seen as a valuable resource for staying current on regulatory, manufacturing, and supply chain topics.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#65
Singapore/News/Business News
Apple Podcasts
#134
Norway/News/Business News
Apple Podcasts
#231
India/News/Business News
Apple Podcasts
#241
Belgium/News/Business News

Talking Points

Recent interactions between the hosts and their guests.

How the Framework of Modern Pharma Manufacturing Is Being Rebuilt: Part One
Q: When you look at small molecule manufacturing today compared to when you started, what progress are you most encouraged by and where do you think the industry has the most to work to?
The field has become more collaborative between chemists and engineers, with better process understanding, safety, and quality progression through concepts like quality by design and by control; ongoing challenges include fully implementing end-to-end continuous manufacturing and expanding automation and data-driven control across multiple unit operations.
Accelerating Biopharma Manufacturing Through Integrated Automation
Q: What does good look like across process control, digital quality, and planned operations as organizations scale?
Good performance combines deterministic control with advanced analytics, AI-embedded decision support, and a unified quality thread across facilities to reduce first-batch risk and enable reliable, scalable operations while improving recall management and overall patient outcomes.
Accelerating Biopharma Manufacturing Through Integrated Automation
Q: Over the past few years, what are some of the biggest shifts or trends you've seen in the manufacturing side of biopharma?
The industry is seeing a massive shift driven by the pipeline of new treatments, increased AI-assisted drug discovery, and a pressing need for speed and predictability in facility launches and scale, along with greater focus on energy and water/resource efficiency.
Charting Pharma Manufacturing Trends: Part One
Q: What are the main challenges for large pharma when shifting from batch to continuous manufacturing?
The key obstacles include massive capital expenditure, the need to redesign development roadmaps, regulatory and filing implications, and the difficulty of integrating new continuous processes with legacy products and facilities—creating a long and complex transition path.
Charting Pharma Manufacturing Trends: Part One
Q: Why do you think end-to-end continuous manufacturing is gaining momentum now?
The move is driven by the potential for dramatically higher productivity, better facility utilization, and lower material use, coupled with longer asset amortization; however, it requires greater automation, inline monitoring, and a complete redesign of many unit operations to work in a continuous flow.

Audience Metrics

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Frequently Asked Questions About This Podcast

What is This Podcast about and what kind of topics does it cover?

The show features in-depth conversations with industry leaders across pharmaceutical manufacturing, from CDMO collaborations and mega-scale capital projects to regulatory shifts, advanced manufacturing, and next-generation modalities like CGT and ADCs. Episodes frequently explore real-world governance, risk management, and implementation challenges—covering topics such as domestic manufacturing strategies, resilience of the medicine supply, automation and data-enabled manufacturing, and the evolving regulatory landscape. A standout is its focus on practical paths to scale, including governance models, supplier partnerships, and end-to-end solutions that bridge science, engineering, and policy. This makes it a strong listen for executives, e... more

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1. The Journal.
2. The NPR Politics Podcast
3. The Daily
4. Up First from NPR
5. Pivot

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this podcast launched 6 years ago and published 133 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 this podcast?

Recent guests on this podcast include:

1. Dr. Thomas Roper
2. Jim Masso
3. Jeff Mason
4. Sebastián Arana
5. David Thaisrivongs
6. Dr. Sharad Kotturi
7. Sharad Kotturi
8. Wayne Lem

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