Bridging the gap between research and GMP in biologics therapy development
HALiXPEDITE Platform
Understanding the impact and hidden costs of delayed development
Researchers often have limited access to pre-clinical and GMP infrastructure, knowledge, and expertise on the required process steps during the late stages of drug development. Without sufficient support, this results in them enduring months, if not years, navigating the complex landscape of pre-clinical and GMP compliance to achieve their first in-human validation of novel drugs. This can lead to significant financial strain and lost competitive advantage.
Eight out of ten academic and biotech researchers report 1) a disconnect in knowledge and expertise between research and (pre-)GMP development stages, and 2) limited access to GMP production facilities and expertise.
Source: Oncode Accelerator study
Knowledge silos between R&D and production exacerbate inefficiencies. As traditional models delay integrating production expertise, projects encounter bottlenecks and escalating costs. This fragmented approach can derail promising candidates, leading to financial strain and diminished competitive advantage.
Every day of delay in launching a novel therapy can result in up to nearly $800,000 in lost revenue and extends the wait for critical treatments for patients in need.
Source: Updates on the Value of a Day of Delay in Drug Development, Contract Pharma
Traditional models wait too long to incorporate production expertise, resulting in inefficiency, increased project costs, and suboptimal scalability and regulatory preparedness. Researchers often endure months, if not years, navigating the complex landscape of IND-filing and GMP compliance due to inefficient support. This leads to significant financial strain and lost competitive advantage.
Imagine dedicating years to developing a brilliant project only to shelve it due to a lack of access to pre-GMP know-how. Without a streamlined, integrated platform bridging this gap, vital months are lost—months that could be spent refining the product or addressing market needs, potentially affecting the lives of patients who need new therapies.
The HALiXPEDITE platform
HALiXPEDITE is revolutionizing the late-stage development of biologics by delivering unparalleled speed, efficiency, and readiness. This collaborative, integrated platform brings researchers and manufacturing experts together early in the development pipeline, not only accelerating your project but also significantly reducing the risks and costs associated with late-stage development hurdles.
Why is HALiXPEDITE different
The HALiXPEDITE platform offers a comprehensive approach, providing integrated expertise and infrastructure from cell line development to GMP production, lowering costs and shortening timelines. By seamlessly bridging late-stage R&D with in-house GMP manufacturing, HALiXPEDITE accelerates the pathway to FiH trials for antibody-based therapies. It offers:
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- Early collaboration bridging late R&D and GMP
- Access and training in pre-clinical and GMP-compliant antibody manufacturing
- Alignment of scientific exploration and market demands from day one
Part of the platform offering includes 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 also to crucial alliances and partnerships necessary to support innovative therapies across various areas, such as:
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- Intellectual Property
- Machine Learning and AI
- Chemistry, Manufacturing, and Control Management (CMC), and more.
This is all facilitated through a single point of contact via HALiXPEDITE, ensuring timely, efficient, and effective collaboration.
