Fresenius Kabi and Phlow Corp. Enter First US End-to-End Manufacturing Collaboration

Fresenius Kabi and Phlow Corp. have announced a collaboration to onshore the manufacture of epinephrine injection, USP, including the production of APIs and finished doses.¹ This first-of-its-kind initiative represents a strategic response to the chronic shortages that have long impacted the availability of this essential medicine in the US. The arrangement utilizes a divided production model where Phlow Corp. produces the APIs at its advanced manufacturing campus in Virginia, while Fresenius Kabi manages the formulation and production of finished doses at its existing US facilities.

How Does This End-To-End Model Address Domestic Supply Chain Vulnerabilities?

The integration of API and finished dose manufacturing is a significant development because, while domestic production of the finished injection has existed, there has been no US-based source for the epinephrine API. To address this gap, a successful US-based validation campaign for the API was recently completed, and a Drug Master File has been filed with FDA.¹ This move aligns with a broader local-for-local strategy supported by over $1 billion in investments to modernize domestic manufacturing and logistics centers. Joel Rosenstack, president, US pharmaceuticals at Fresenius Kabi, stated in a press release,¹ “Fresenius is a committed partner in advancing America’s vision of a fully domestic, end-to-end, supply chain for essential medicines, closing a vital gap in national security.” By establishing a domestic source for both components, the collaboration aims to secure the supply of a drug indicated for critical applications, including the treatment of anaphylaxis and increasing mean arterial blood pressure during septic shock.

Why Is a Scalable Manufacturing Framework Vital for Future Pharmaceutical Security?

This collaboration is designed to be a scalable model that can be applied to other essential medicines identified by FDA and the WHO. The focus is on creating resilient supply assurance through tech-enabled processes and advanced development techniques. Eric Edwards, MD, PhD, CEO of Phlow, noted in a press release that, “Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America’s national health security”. He further commented, “For several years, we have worked alongside Fresenius Kabi to build resilient, end-to-end supply assurance for essential medicines. This expanded collaboration is focused on securing a reliable domestic supply of epinephrine, one of the most critical, life-saving drugs used across emergency and acute care settings in the United States.”¹ Pending necessary regulatory approvals, the product resulting from this domestic pipeline is expected to be available to US hospitals in 2027, potentially setting a new standard for how critical care medicines are developed and manufactured domestically.

How Else Is Fresenius Kabi Utilizing Collaborations?

Beyond the onshoring of traditional injectables, the drive for manufacturing innovation extends into the emerging field of cell and gene therapy. A strategic development agreement between Fresenius Kabi and TQ Therapeutics aims to enhance accessibility by enabling scalable and efficient manufacturing through integrated cell selection technology. Under this agreement Fresenius Kabi has the ability to develop, produce, and distribute products that are created with TQ Therapeutics’ proprietary cell selection technology.²

How Is Automated Cell Selection Streamlining Complex Manufacturing Workflows?

The integration of affinity and column-based isolation technology into automated processing systems is designed to produce high-purity cells quickly and consistently. This addresses the significant manufacturing challenges associated with process development and full commercialization. Saurabh Bhasin, head of Portfolio, Cell Therapies & contract manufacturing operations at Fresenius Kabi, noted in a press release,² “By integrating TQ Therapeutics’ novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability—key steps toward supporting the advancement of cell and gene therapies.”

What Role Does Point-of-Care Processing Play in the Future of Individualized Medicine?

Advancing these technologies allows for ultra-short processes that can be performed closer to the point of care, simplifying treatment workflows. This modular approach supports the development of next-generation therapies delivered directly to the patient. “With Fresenius Kabi’s expertise in cell and gene therapy device technologies development and commercialization, and TQ Therapeutics' focus on developing ultra-short processes for clinical cell therapies from manufacturing to in vivo applications, we are creating a novel value proposition for scaling and enabling the supply of cell therapies for broader patient populations,” stated Christian Eckert, CEO of TQ Therapeutics, in a press release. Such advancements reflect a broader commitment to utilizing technological knowledge to ensure access to world-class therapies through improved clinical practice and industrial production.

References

1. Fresenius Kabi. Fresenius Kabi and Phlow Corp. Announce First-Ever, End-to-End, U.S. Manufacturing Collaboration for Epinephrine Injection, USP. Press Release. Feb 9, 2026.
2. Fresenius Kabi. Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement. Press Release. Feb 9, 2026.