Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

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The intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products.

In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence.

Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform can process multiple patient doses simultaneously, enabling treatment for 30 patients in parallel within just 1,000 square feet of clean room space. This innovative method drastically reduces clean room requirements by about 95% and facility sizes by approximately 50%, significantly cutting costs associated with building and operating large-scale facilities.

As Jason emphasized, this shift not only accelerates access to groundbreaking therapies but also provides a sustainable model for scaling cell therapy production.

Key Points to Remember:

• Integrated Approach: Scientists should look beyond their specialized areas and understand the requirements of subsequent bioprocessing stages to maximize patient impact.
• Technological Evolution: Advancing distributed manufacturing and enhancing in-line analytics are essential steps to revolutionize the biotech landscape.
• Commercial Viability: Prioritizing commercial feasibility alongside safety and efficacy in preclinical development can prevent costly late-stage setbacks.

This episode of the Smart Biotech Scientist underscores the complexities and transformative potential of cell therapy manufacturing. As the industry continues to innovate, integrating commercial viability, flexibility, and advanced manufacturing solutions will be critical. By breaking down silos and fostering collaboration, we can accelerate the development of life-saving therapies—ensuring they reach patients faster and more efficiently.

Connect with Jason Foster

LinkedIn: https://www.linkedin.com/in/jasoncfoster

Oribiotech: https://oribiotech.com

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

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Imagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone’s reach. In this episode of the Smart Biotech Scientist, David Brühlmann explores how innovative biotech developments are making this vision a reality.

Here’s a sneak peek of the breakthroughs covered:

• AI-Powered Picoliter Scale Testing: Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microfluidic technology that screens individual cells. Their approach enables rapid identification the best cell producers, paving the way for more efficient and precise bio-manufacturing.
• Hybrid Models for Process Prediction: Learn about DataHow's cutting-edge hybrid models that predicts process outcomes and improves product quality. Their models have demonstrated the potential to reduce the number of experiments by up to 80%.
• Unconventional Bioreactor Approaches: Explore an intriguing proposition – could tomorrow's bioreactors be living organisms like goats? BioSourcing is exploring the potential of transgenic goats to produce biopharmaceuticals more affordably, a concept that could dramatically lower production costs and enhance accessibility.

The future of biotech is not just about technological advancement; it’s about embracing the impact these innovations can have globally. As David urges, the challenge is no longer about if these changes will happen, but how quickly we can achieve them.

Stay curious, keep innovating, and be part of this exciting transformation in biotech. Your contributions and feedback could shape the next generation of breakthroughs.

Listen, learn, and let us know what you think about these advancements. We can’t wait to hear from you!

If you enjoyed this, here are some episodes worth listening:

• Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All
• Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
• Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily
• Episode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches
• Episodes 41-42: Revealing the Disciplined Pursuit of Less in Bioprocessing

Next step:

Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/call

Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a text

One of the most urgent challenges in modern medicine is making cell and gene therapies widely accessible. These therapies, while groundbreaking in their safety and efficacy, often fall short when it comes to reaching patients. The reasons are manifold—high manufacturing costs, logistical complexities, and inefficiencies in the production pipeline.

We're joined by Jason Foster, CEO and Executive Director of Ori Biotech, a company that's revolutionizing cell and gene therapy manufacturing through automation and innovative approaches.

Jason sheds light on the technical bottlenecks that limit patient access to life-saving therapies and discusses how an integrated, holistic view of the development chain could make a significant difference. From the complexities of centralized manufacturing and the interconnectedness of the supply chain, to specific technical solutions Ori Biotech has developed, we explore the multi-faceted issues and potential solutions in making these advanced therapies more reachable.

Here are three key takeaways from our conversation:

• Holistic Development Chain: Jason emphasizes the importance of integrating all stakeholders in the development chain, ensuring everyone understands what happens before and what needs to happen next to improve the overall process.
• Technical Bottlenecks & Solutions: We delved into various technical bottlenecks, including centralized manufacturing and logistical complexities. Jason highlighted how Ori Biotech is addressing these issues through automation and reducing manual labor, which can cut manufacturing costs by 50%.
• Impact on Accessibility: It's alarming that only 3-5% of patients who need CAR-T therapies have access to them. Jason's mission with Ori Biotech is to transform this narrative by enabling widespread access to these life-saving therapies through innovative manufacturing solutions.

As cell and gene therapies stand poised to revolutionize cancer and rare disease treatment, the focus must shift toward overcoming manufacturing constraints. By integrating automation and aiming for decentralized models, companies like Ori Biotech offer a glimpse into a future where these revolutionary treatments are accessible to all who need them.

Fascinated by Cell Therapy? Hear from top experts in these two episodes!

• Episodes 11 and 12: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development
• Episodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata

Connect with Jason Foster

LinkedIn: https://www.linkedin.com/in/jasoncfoster

Oribiotech: https://oribiotech.com

Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a text

Are you struggling to unlock the full potential of Process Analytical Technology (PAT) in biomanufacturing?

Look no further!

Join us for a game-changing conversation with Abhijeet Satwekar, an Innovation Manager at Merck Guidonia-Rome, Italy.

Discover how PAT can revolutionize your decision-making, accelerate development timelines, and propel your biotech company to new heights.

Key Learnings:

1. Decoding PAT's Impact: Abhijeet provides unprecedented insights into how PAT technologies revolutionize decision-making in real-time, ensuring unparalleled control over manufacturing processes. Discover the race towards achieving real-time release and initiatives propelling patient-centric value.
2. Fast-Tracking Development Timelines: Explore the potential of PAT in risk reduction by gaining step-by-step insights into process evolution. Uncover how comprehensive data capture can slash Quality Control testing lead times, potentially transforming weeks into mere days.
3. Mastering PAT Implementation Strategies: Abhijeet advocates for simplicity in adopting PAT, commencing with a strategic voice-of-customer approach. Delve into critical process points, select PAT tools judiciously, and establish equivalence with traditional methods for seamless integration.

Get ready to harness the power of PAT and gain a competitive edge in the digital transformation of biomanufacturing.

Don't miss out on this opportunity to become a PAT expert and unlock endless possibilities for success!

Connect with Abhijeet Satwekar:

LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar/

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In the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable.

The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and efficacy. At the heart of this transformation is the shift from traditional process formats like fed-batch to continuous process formats, quality by design approaches, and the implementation of breakthrough technologies.

Here's a quick rundown of the key takeaways:

• Revolutionary Process Designs: Industry leaders are enhancing bioprocess designs—from antibody production enhancements to integrating perfusion mode. One case study highlighted a dramatic increase in viable cell density and protein titers through intensified processes.
• Quality Control Innovations: Companies like Cyto-Facto are pioneering quality by design in the challenging cell and gene therapy space. By leveraging sophisticated PAT systems, they can monitor critical process parameters in real-time, ensuring consistent quality even in complex bioprocesses.
• Metabolite Shifts and Efficacy: A surprising discovery revealed the power of metabolite shifts induced by cell culture media design, inspired by an intriguing study on cyclists, to enhance antibody efficacy and stability. This opens new possibilities for engineering the quality of biopharmaceuticals through simple modifications in the culturing process.

The innovations discussed in the Smart Biotech Scientist illustrate a pivotal transformation in bioprocessing. By rethinking process designs and committing to quality control, the biotech industry is paving the way for groundbreaking therapies that are not just dreams but realities - realities that are tangibly more accessible to patients worldwide.

As we anticipate more developments in this field, the promise of biotech becomes increasingly certain: a future where life-saving treatments are affordable and available to all who need them.

Catch the full episode to explore how these innovations are not just improving efficiency but making life-saving therapies more accessible globally.

If you enjoyed this, here are some episodes worth listening:

• Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All
• Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
• Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily
• Episode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches
• Episodes 41-42: Revealing the Disciplined Pursuit of Less in Bioprocessing

Next step:

Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/call

Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech