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GMP Manufacturing

Aragen offers advanced cGMP capabilities, including bioreactors with expansion potential up to 21KL and dedicated small-scale facilities for agile production. Our proprietary RapTr2022 platform and unique CHO cell lines enable high-quality protein expression. By integrating state-of-the-art technology with dedicated process development laboratories, comprehensive quality control (QC), and rigorous quality assurance (QA) practices, we ensure compliance with the highest GMP standards at every phase of the production lifecycle.

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 manufacturing facility operates in full compliance with GMP 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 manufacturing model ensures a smooth transition from lab scale (Ambr 250) to pilot scale (50L bioreactor) to production scale (2000L bioreactor) operations.
  • Stage flexibility: Supports non-GMP, clinical and commercial stage projects.
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