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Articles by Rohit Harve
10.23.25 -- Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy
Webinar: How to Address Your Solid Dosage Processing Needs? This webinar helps manufacturers align product needs with processing strategies and equipment choices. Participants will learn to evaluate requirements, select techniques for quality and consistency, and monitor processes effectively. By the end, attendees will gain practical tools to ensure uniform, reliable, and compliant products. Key takeaways include understanding processing needs, monitoring effectively, and achieving consistency.
09.26.25 -- Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.
Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined Unlock the keys to successful First-in-Human studies with Quotient. This webinar reveals how expert-designed SAD/MAD trials, flexible CMC strategies, and smart regulatory planning accelerate proof-of-concept while avoiding costly setbacks. Gain insider insights on biomarkers, patient recruitment, and data integration—plus real-world case studies across rare diseases, obesity, CNS, and inflammation.
Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy Original
By Rohit Harve, Jamison Roof, and Erik Moen, PA Consulting Between 2018 and 2023, the number of biopharma manufacturing facilities in the U.S. grew by over 50%. Amid recent tariff threats, pharma companies are investing even more heavily in U.S. manufacturing. Collectively, 11 top pharma companies are investing nearly $230 billion in expanding their domestic footprints, including building more than 25 new manufacturing facilities and upgrading existing plants over the next five years.
Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy
By Rohit Harve, Jamison Roof, and Erik Moen, PA Consulting Between 2018 and 2023, the number of biopharma manufacturing facilities in the U.S. grew by over 50%. Amid recent tariff threats, pharma companies are investing even more heavily in U.S. manufacturing. Collectively, 11 top pharma companies are investing nearly $230 billion in expanding their domestic footprints, including building more than 25 new manufacturing facilities and upgrading existing plants over the next five years.
Using Generative AI For Smarter, Faster, More Predictive Biopharma Ops
Guest Column | June 16, 2025 By Rohit Harve, Srinivas Rowdur, and Erik Moen The biopharma industry is rapidly evolving. As such, biopharma companies are facing a variety of operational challenges stemming from a high volume of siloed data coupled with regulatory scrutiny that impedes the application of new technologies. This has resulted in a high degree of manual effort to extract insights from data. A recent client situation exemplifies these challenges.
Using generative AI for smarter, faster, more…
This has resulted in a high degree of manual effort to extract insights from data. A recent client situation exemplifies these challenges. At the company’s midsized biologics plant, three consecutive manufacturing runs had missed their yield specification by double-digit percentages, yet nothing obvious in the process history differed from the high-performing campaigns of the previous month.
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