Robust upstream processes are essential for predictable product quality and a smooth path toward GMP readiness.
We design processes built on scientific understanding, analytical insight, and structured experimentation — delivering reliable performance across CHO, SP2/0, and NS0, and across molecule classes including antibodies (IgG1, IgG2, IgG4, and bispecific formats), Fc-fusion proteins, glycohormones, cytokines, enzymes, and clotting factor.
Our process development strategy is built around molecule-specific CQAs. Each step — from media and feed screening to parameter optimization — follows a controlled, traceable workflow. Analytical readouts are integrated early and evaluated using statistically informed approaches, ensuring that product quality remains aligned across scales and that CMC decisions are well-grounded.
We combine scientific depth with scalable systems, enabling processes that perform reliably from early development through advanced development stages.
Our deliverables provide clarity, stability, and the documentation required for efficient technology transfer and GMP readiness.
Our CMC development work is built on consistent, reproducible execution across a broad range of molecules and expression systems. The scope and outcomes of this work are documented in our Track Record.
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