Industrial Hygienist

Partnership will onshore manufacturing to stabilize and secure US epinephrine supply. 2026/03/18 Fresenius Kabi and Phlow Corp have announced a major collaboration to onshore the complete manufacturing process of Epinephrine Injection, USP. The partnership aims to establish a fully domestic, end-to-end supply chain for a critical medicine that has faced ongoing supply chain challenges. By combining their expertise, the companies seek to improve the reliability of a life-saving drug used across emergency and acute care settings. Today, much of the epinephrine supply chain relies on a global network of manufacturers, with key components - particularly the active pharmaceutical ingredient (API) - often produced overseas before being shipped to the United States for final formulation and packaging. This fragmented system has introduced vulnerabilities, including delays, variability in quality, and exposure to geopolitical or logistical disruptions. As a result, even widely used, off-patent drugs like epinephrine have faced periodic supply constraints, highlighting the challenges of maintaining a stable supply of essential medicines in a globally dependent manufacturing model. While Fresenius Kabi has historically produced finished epinephrine doses domestically, the US has lacked a domestic source for the active pharmaceutical ingredient. Under the agreement, Phlow will produce the API at its Virginia-based facility, with Fresenius Kabi handling final formulation and manufacturing in the US. The initiative is rooted in national health security and efforts to reduce reliance on overseas suppliers. Company leaders emphasized the importance of building a resilient domestic supply chain for essential medicines. Joel Rosenstack, President of US Pharmaceuticals at Fresenius Kabi, underscored the mission, noting the company's commitment to advancing a fully domestic supply chain for critical drugs. Phlow has already completed a US-based validation campaign for the epinephrine API and submitted a Drug Master File to the FDA, supporting regulatory alignment and quality standards. Leaders from both organizations describe the collaboration as a scalable model that could be applied to other essential medicines identified by regulators. Eric Edwards, MD, PhD, CEO of Phlow, and co-developer of the Auvi-Q auto-injector, emphasized the importance of securing a reliable domestic supply of epinephrine, a drug widely used in emergency and acute care settings. The effort aligns with Fresenius Kabi's broader "local-for-local" strategy, supported by significant investment in US manufacturing and logistics infrastructure. Pending regulatory approvals, the partners aim to bring the domestically produced supply to market in the coming years - offering a more resilient and reliable source of this essential medication for US healthcare providers.

Phlow Corp. appoints Dawn Von Rohr as Chief Operating Officer to advance domestic pharmaceutical manufacturing. RICHMOND, Va., March 18, 2026 - Phlow Corp., a leading American advanced pharmaceutical contract development and manufacturing organization (CDMO), today announced that Dawn Von Rohr has been appointed Chief Operating Officer (COO). Von Rohr will oversee Phlow's operations, manufacturing execution, and strategic growth initiatives as the company continues expanding its advanced pharmaceutical development and manufacturing infrastructure in the United States to strengthen secure domestic production of medicines and active pharmaceutical ingredients (APIs). The appointment reflects Phlow's continued investment in experienced, world-class operational leadership as the company scales its platform to strengthen domestic pharmaceutical manufacturing, support a more resilient supply chain, and advance pharmaceutical sovereignty. "Phlow was founded with a bold purpose to create the future of how medicines are made in America," said Eric S. Edwards, M.D., Ph.D., Co-Founder and CEO of Phlow. "As we continue scaling our advanced development and manufacturing capabilities, as well as supporting the U.S. Government's essential medicine programs and biopharma customers with their own reshoring initiatives, Dawn brings the operational leadership, extensive experience in API manufacturing, and global manufacturing expertise needed to scale our platform and help bring medicines to life in America." Von Rohr brings more than 30 years of deep experience in pharmaceutical manufacturing, global supply chain operations, and operational leadership across the life sciences industry. Most recently, she served as President of the Life Sciences Division at Pace Life Sciences, where she led a network of nine facilities supporting pharmaceutical customers through analytical services, formulation development, and manufacturing support. Prior to Pace Life Sciences, Von Rohr held senior leadership roles at Curia Global, including Senior Vice President of Strategy and Head of Global API Operations, spanning multiple manufacturing sites across the U.S., Europe, and India. She spent more than two decades at Mallinckrodt Pharmaceuticals, where she served as Vice President and General Manager of Global APIs. Her overall career experience includes scaling complex manufacturing operations, leading large capital investment projects, optimizing global supply chains, and delivering sustained growth across pharmaceutical product portfolios. "Phlow represents an extraordinary opportunity to help shape the future of pharmaceutical manufacturing in America," said Dawn Von Rohr, Chief Operating Officer of Phlow. "The company has built a powerful platform that combines scientific expertise, advanced manufacturing infrastructure, and technology-driven innovation to strengthen the nation's medicine supply chain. I look forward to working alongside this exceptional team to scale operations and deliver reliable, high-quality medicines for patients across the United States." Von Rohr's appointment comes at a pivotal moment as the United States continues investments in national preparedness and readiness through Phlow's Strategic Active Pharmaceutical Ingredient Reserve (SAPIR) program, while industry partners increasingly seek reliable U.S.-based development and manufacturing capabilities to improve supply chain resilience. About Phlow Corp. Phlow, a B Corporation(TM), helps brilliant minds bring medicines to life through advanced development and manufacturing in America. Focused on innovations in drug substance development, Phlow supports government and private industry customers to create innovative approaches with scientific expertise, world-class manufacturing, and tech-enabled processes that propel the industry forward to a new standard as Phlow Corporation create the future of how medicines are made. As a modern contract development and manufacturing provider, Phlow Corporation measure its impact by increasing speed to market, reducing waste, and offering an environmentally friendly approach to manufacturing medicines that lead to healthy, resilient communities. For more, visit phlow-usa.com.

Phlow and Enveda partner to advance ai-driven chemistry to accelerate domestic pharmaceutical development and transform drug substance manufacturing. RICHMOND, Va., January 14, 2026 - Phlow Corp., a leading American pharmaceutical contract development and manufacturing organization (CDMO), today announced a major advancement in AI-driven Active Pharmaceutical Ingredient (API) manufacturing process development in collaboration with Enveda, a biotechnology company that learns from life's chemistry to create better medicines faster. Through a joint pilot program launched last year to rapidly select API routes, the companies demonstrated that high-quality, internally generated reaction data can significantly improve AI-based predictions of chemical reaction kinetics, yields, and purity profiles, compressing development timelines from years to months. In just three months, Phlow and Enveda generated and analyzed nearly 20,000 unique reactions, creating one of the largest high-quality data sets of its kind. The resulting uniform dataset is significantly larger than any publicly available dataset to date and is comparable in scale to proprietary reaction datasets assembled over decades by major pharmaceutical companies. By training AI models on this internally generated data, the teams achieved substantially more accurate yield predictions than models trained on public datasets alone. "This is about setting a new standard for pharmaceutical development and manufacturing," said Eric S. Edwards, M.D., Ph.D., Co-Founder and CEO of Phlow. "By combining Phlow's advanced API development and manufacturing expertise with Enveda's leading AI-driven insights and deep learning capabilities, we are creating a first-of-its-kind, innovative platform that predicts the optimal synthesis route the first time, every time, faster and more accurately than any other database. Together, we're creating the future of how medicines are made with speed, precision, and resilience." The collaboration compared traditional machine learning approaches with deep learning models, specifically graph neural networks that represent molecules as connected networks of atoms and bonds. This approach more closely reflects real-world chemistry and delivers stronger predictive performance, demonstrating the value of deep learning for reaction optimization and future retrosynthetic planning. "This collaboration demonstrates what becomes possible when high-quality experimental data and modern AI are tightly integrated," said Viswa Colluru, Ph.D., Chief Executive Officer of Enveda. "Accurate reaction prediction depends not just on algorithms, but on the quality, structure, and scale of the data behind them. By learning from carefully generated chemical data, we can move faster, reduce experimental burden, and create more reliable paths from discovery to development." The ability to rapidly generate, analyze, and integrate reaction data into AI models represents a meaningful step forward for chemical and pharmaceutical development. By reducing reliance on trial-and-error experimentation, this approach supports faster optimization of synthetic routes, improved scalability, and more efficient development of essential medicines. "This capability reflects Phlow's ability to rapidly operationalize AI at scale, reinforcing a core belief that data quality and execution are decisive advantages," said Juan Piacquadio, Chief Information Officer at Phlow. "When experimental systems, data pipelines, and advanced AI models are intentionally designed to work together, we can achieve outcomes in months that historically required many years. This is how modern, technology-enabled infrastructure accelerates pharmaceutical innovation while strengthening domestic manufacturing resilience." Building on this success, Phlow and Enveda plan to deepen the collaboration and expand the AI-driven framework to additional reaction classes, applying deep learning to a retrosynthetic analysis platform, enabling faster, more efficient, and more sustainable chemical synthesis across a broader range of applications. This work lays the foundation for a best-in-class predictive system that delivers the optimal synthesis route the first time, every time, additional intellectual property, and additional long-term value for both organizations. Phlow, a B Corporation, helps brilliant minds bring medicines to life through advanced development and manufacturing in America. Focused on innovations in drug substance development, Phlow supports government and private industry customers with scientific expertise, world-class manufacturing, and tech-enabled processes that move the industry toward a new standard as Phlow Corporation create the future of how medicines are made. For more information, visit phlow-usa.com. About Enveda Enveda is a clinical-stage biotechnology company that learns from life's chemistry to create better medicines faster. Enveda uses AI-powered tools to identify and characterize a wide range of molecules produced by living organisms, the vast majority of which have never been explored by science, creating a database of chemical biodiversity, the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life's evolved solutions to address today's most pressing medical needs. For more information, visit enveda.com.