SAN FRANCISCO CHAPTER OF ISPE

In an effort to reduce operational expenses, a prominent manufacturer of life-sustaining proteins initiated a process to replace a specific HPLC method to a more efficient Total Organic Carbon (TOC) method for routine cleaning verification and product changeovers. However, this cost-saving measure immediately ran into a hurdle. A four-week pilot study showed that the company's existing lab-based cleaning protocol, when paired with the new TOC method, would add approximately $54,000 to costs.

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Natalie

- What are the key challenges and opportunities posed by the transition to digital validation tools in the pharmaceutical industry, and how can NGOs support this transformation?

Laura

Great to see ISPE leading the charge towards digital transformation in the pharmaceutical industry! Excited to follow along and learn more about how these advancements can improve patient care. 🌍💊

Michael

Looking forward to seeing how the inclusion of process architects will enhance pharmaceutical manufacturing! Investing in our people is truly the key to better health outcomes for everyone. 🙌🔬

John

- How can the integration of process architects in pharmaceutical production facilities enhance employee well-being and the overall efficiency of drug manufacturing?

SAN FRANCISCO CHAPTER OF ISPE

The pace of innovation—digital joined with operational excellence—is transforming pharmaceutical development, manufacturing, and the supply chain. Artificial intelligence, robotics, advanced analytics, smart facility design, and innovation culture are no longer “future concepts. ” They are here, and they bring real challenges.

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