Eurofins CDMO Alphora supports the development and manufacturing of monoclonal antibodies (mAbs) with upstream, downstream, analytical, and GMP capabilities on a single North American campus. Whether your program is at research, IND‑enabling, or early clinical stages, our team helps streamline CMC execution while maintaining scientific rigour, clear communication, and alignment with regulatory expectations.
Our capabilities scale seamlessly from early-stage development to commercial manufacturing, supporting processes from small-scale batches to 2,000L single-use bioreactors, including perfusion systems up to 500L.
Leveraging a fully integrated single-use GMP production train, our experienced team delivers flexible, high-quality biologics manufacturing solutions designed to meet diverse client requirements efficiently and reliably.
Using our deep understanding of CHO and HEK cell lines, our experts design and optimise cell culture processes that maximise viable cell density, productivity, and product quality.
We apply Design of Experiments (DoE) methodologies to build robust, data‑driven process models that scale predictably. Single‑use upstream trains help minimise contamination risks and simplify process transitions as programmes advance.
Our downstream team brings extensive experience purifying a wide range of mammalian‑based biologics — including mAbs, bispecifics, Fc‑fusion proteins, recombinant proteins, exosomes/VLPs, and payload‑bearing intermediates.
Each purification strategy is developed with scalability, impurity control, and manufacturability in mind, ensuring a smooth path from pilot‑scale results to GMP execution.
Our development scientists support efficient scale‑up using integrated single‑use technologies designed to reduce contamination risk and streamline transitions from development to GMP manufacturing.
This structured approach ensures that cell culture performance, purification behavior, and analytical methods transfer cleanly between scales.
Our analytical team provides phase‑appropriate testing and method development to support upstream & downstream workflows, and GMP release testing.
Analytical readiness is integrated early in development to ensure smooth progression into GMP manufacturing.
Our 2000 L GMP production train enables clinical and commercial manufacturing.
Our GMP biologics suites are designed for flexibility, batch consistency, and efficient changeover across varying program types.