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Artwork for Off Script: A Pharma Manufacturing Podcast

Off Script: A Pharma Manufacturing Podcast

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

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!

PublishesWeeklyEpisodes137Founded6 years ago
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Artwork for Off Script: A Pharma Manufacturing Podcast

Latest Episodes

The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful ... more

Single-use technologies have reshaped biopharma manufacturing facility design, capacity strategy, and flexibility over the past decade. The industry has expanded with a growing range of targeted therapies and emerging modalities, which has led to man... more

Biopharmaceutical manufacturing processes are becoming more complex, prompting manufacturers to evaluate filtration based on its impact across the entire process rather than as a standalone unit operation. Filtration decisions can influence everythin... more

A unique team of specialists in data generation and artificial intelligence are co-developing an AI genomic model capable of predicting genomic edits that improve commercial-scale protein production. This collaboration between Triplebar and UC Berkel... more

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Recent Guests

Charlie Heise
Associate Director of Bioprocess Strategy and Development for Fujifilm Biotechnologies
Fujifilm Biotechnologies
Episode: Single-Use Technologies and the Future of Flexible Biomanufacturing
Hannah Hertrick
Market Development Manager of Filtration Products
Saint-Gobain Critical Process Solutions
Episode: Solutions Spotlight: Rethinking Filtration as a System-Level Design Decision
Shawn Manchester
CEO of Triplebar
Triplebar
Episode: How Genomic Language Models Could Accelerate Biomanufacturing
Fabian Gerlinghaus
Co-founder and CEO of Cellares
Cellares
Episode: The FDA's PreCheck Program and the Future of Cell Therapy Manufacturing
Tom Belling
Global Director of Life Sciences at Emerson
Emerson
Episode: Solutions Spotlight: Improving Sustainability Through Smarter Steam System Monitoring
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

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

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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

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Talking Points

Recent interactions between the hosts and their guests.

How Genomic Language Models Could Accelerate Biomanufacturing
Q: What does success look like for this model in commercial scales?
Success means achieving higher titers across key modalities, enabling cheaper, faster production, and shortening the path from idea to pilot production to under six months, thereby expanding the product pipeline and reducing development risk.
How Genomic Language Models Could Accelerate Biomanufacturing
Q: What are the initial applications and why start with bio manufacturing?
Biomanufacturing presents high-value data generation opportunities and a clear economic need to reduce costs and improve yields, especially for antibodies. The data-rich environment is well-suited for training models that can suggest edits and pathways to boost production.
How Genomic Language Models Could Accelerate Biomanufacturing
Q: Can you explain what a genomic language model is and how it differs from existing AI tools used in biology?
A genomic language model is like a natural language model but trained on biological sequences such as nucleotides and amino acids. It aims to understand patterns and structures in genomes and proteins so it can answer questions about how to modify a sequence to improve production, much like language models answer questions about sentences, but for biology.
The FDA's PreCheck Program and the Future of Cell Therapy Manufacturing
Q: What made Cellares stand out in the PreCheck selection, and how does the company view its role as an IDMO in the cell therapy space?
Cellares is uniquely positioned as a fully automated, end-to-end platform for cell therapy manufacturing, combining the AMT designation with a first-of-its-kind integrated development and manufacturing model, which the FDA recognized by selecting them as the sole cell-therapy platform in the inaugural cohort.
The FDA's PreCheck Program and the Future of Cell Therapy Manufacturing
Q: Why did Cellares pursue participation in the FDA's PreCheck pilot program, and how does it benefit automated cell therapy manufacturing?
PreCheck shifts facility readiness and inspections earlier in the development cycle, reducing the risk on commercial timelines by removing manufacturing from the critical path and enabling customers to proceed toward regulatory approvals with more certainty and faster time to market.

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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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this podcast launched 6 years ago and published 137 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. Charlie Heise
2. Hannah Hertrick
3. Shawn Manchester
4. Fabian Gerlinghaus
5. Tom Belling
6. Dr. Thomas Roper
7. Jim Masso
8. Jeff Mason

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