This LinkedIn Live conversation with John Raech, Co-Founder and President of Pharma Resource Group (PRG), was discussion with xLM, as we explored how next generation API manufacturing is being designed from the ground up in the United States.

PRG is building a state-of-the-art API facility in Pennsylvania, purpose-built for continuous flow chemistry and advanced manufacturing. The site is being developed to qualify under the FDA’s Emerging Technology Program (ETP) positioning PRG at the forefront of resilient, high-assurance, U.S.-based API supply.

In this live session, John shared how PRG is rethinking traditional API production through modular flow chemistry, continuous processes, and an end-to-end digital factory vision. The discussion examined how advanced analytics, AI/ML-driven process control, and real-time quality intelligence can fundamentally change how APIs are designed, transferred, released, and regulated.

xLM outlined how its Continuous Intelligence and GxP-ready AI platform supports PRG’s journey toward a paperless, fully digitized, and validation-ready operation, spanning process design, tech transfer, batch release, and ongoing regulatory compliance.

Practical insights on:

1️⃣Architecting an FDA-aligned digital factory from dayone

2️⃣Leveraging the FDA Emerging Technology Program (ETP)to de-risk innovation

3️⃣Applying continuous flow and real-time quality inregulated API manufacturing

4️⃣Using AI and advanced analytics while maintaining GxP and validation rigor

5️⃣Building competitive advantage through speed, quality, and regulatory confidence

If you’re involved in manufacturing, process development, quality, digital transformation, or regulatory strategy, this conversation offers real-world lessons on how continuous manufacturing and digital intelligence are converging to shape the future of pharma production.

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This event is sponsored by ContinuousTV.

https://www.youtube.com/@xlmcontinuoustv

https://continuoustv.beehiiv.com/

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You can reach:

John Raech @ https://www.linkedin.com/in/johnraech/

Nagesh Nama @ https://www.linkedin.com/in/nageshnama/