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GMP Manufacturing Services

Aragen provides biologics GMP manufacturing services as part of an integrated gene-to-GMP platform spanning cell line development, process and analytical development, and clinical and commercial GMP manufacturing. As of March 31, 2026, Aragen had 2.50 KL installed GMP manufacturing capacity for Biologics D&M using single-use bioreactors, supported by upstream process development and quality-control capabilities. Aragen Biologics D&M facility commenced Phase 1 operations in February 2024, followed by Phase 2 GMP operations in November 2025. Aragen intends to expand Biologics D&M capacity from 2.50 KL to 6.50 KL by Fiscal 2028, with potential scale-up to 21.50 KL over the following three years.

Aragen offers the royalty-free RapTr2022 platform supporting CHO-DG44 and CHO-GS cell line workflows. Retain performance or uniqueness claims only with approved technical substantiation. GMP manufacturing is supported by quality control, quality assurance and regulatory processes aligned to applicable project and regulatory requirements.

Designed for optimal cost-efficiency and agility, the facility enhances our collaborative approach, providing unmatched flexibility while consistently delivering exceptional quality throughout the entire process. Our cGMP manufacturing facility operates in full compliance with good manufacturing standards and all relevant regulatory requirements, demonstrating our commitment to the highest quality in biologics production.

The Aragen Advantages

  • Effective tech transfer: Skilled in transferring later-stage projects and optimizing processes based on insights.
  • Predictive scale-up: Predictive models for efficient scale-up from lab to production scale.
  • Seamless scalability: Our integrated development and biomanufacturing model ensures a smooth transition from lab scale (Ambr 250).
  • Stage flexibility: Supports non-GMP, clinical and commercial stage projects.
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