HALiXPEDITE: Transforming Biologics Therapy Development Programs with Seamless R&D to GMP Integration

ROTTERDAM, The Netherlands, April 3, 2025 /PRNewswire/ -- HALIX, a leading global healthcare Contract Development and Manufacturing Organization (CDMO), introduces HALiXPEDITE at the Innovation for Health conference in Rotterdam. With the launch of HALiXPEDITE, HALIX introduces a platform tailored to accelerate biologics therapy development with the goal of a fast track First-in-Human (FiH) approach.

Addressing a Critical Therapeutic Need

"Biologics-based therapies offer transformative potential for a multitude of diseases. Yet, despite their revolutionary promise, the development of these therapies is frequently impeded by substantial financial costs and production challenges, rendering their advancement to clinical readiness a significant hurdle. This contributes to the reality that many projects unfortunately do not succeed into clinical trials," notes Debby Vermeer, Alliance Management at HALIX. "This high failure rate is largely due to a disconnect between late-stage R&D and GMP manufacturing, compounded by limited access to necessary pre-clinical and GMP infrastructure and know-how, resulting in costly delays and inflated expenses that hinder the progress of promising therapies."

HALiXPEDITE: An Integrated Solution

The HALiXPEDITE platform aims to offer a comprehensive approach, providing integrated expertise and infrastructure from cell line development to GMP production, lowering cost and shortening timelines. By seamlessly bridging late-stage R&D with in-house GMP manufacturing, HALiXPEDITE accelerates the pathway to FiH trials for biologics-based therapies.

Part of the platform offering is also access to a state-of-the-art BioHub, designed to connect researchers, drug developers, and industry partners not only to development and manufacturing expertise, but crucial alliances and partnerships necessary to support innovative therapies across various areas, such as Intellectual Property, Machine Learning and AI, Chemistry, Manufacturing and Control Management (CMC). This is all facilitated through a single point of contact via HALiXPEDITE, ensuring timely, efficient and effective collaboration.

"Our mission with HALiXPEDITE is to redefine the landscape of biologics therapy development by providing early process integration and fostering a wide net of expert collaboration," says Dr. Lutz Hilbrich, CEO of HALIX. "By alleviating the burden of early access to infrastructure and expertise, HALiXPEDITE aims to empower researchers to focus on innovation while minimizing financial risk, shortening timelines and maximizing competitive advantage."

To learn more about the HALiXPEDITE platform, visit www.halix.nl/HALiXPEDITE

About HALIX 

HALIX B.V. is a leading healthcare Contract Development and Manufacturing Organization (CDMO) specializing in clinical and commercial-scale biopharmaceutical manufacturing. With a focus on innovation, quality, and speed, HALIX provides solutions for the development and production of recombinant proteins and antibodies, viral vectors, and vaccines. Headquartered in Leiden Bio Science Park, HALIX is committed to supporting global biopharmaceutical advancements.