Technology transfer of a drug substance is a multifaceted activity with inherent technical, regulatory, and quality risks that needs to be addressed. At Aragen, we offer a proven and adaptable approach to technology transfer, whether for scale-up or transitioning to a different facility. Our team of experts have the knowledge and experience to meticulously assess the inherent complexity of your project, ensuring that our transfer scope and strategy align appropriately.
Our goal is to ensure the efficiency and success of the transfer process throughout every phase of your drug’s lifecycle. We are structured to support our manufacturing operation in an FFS-based partnership model, which includes a large-scale commercial cGMP production plant, a cGMP pilot plant, and cGMP kilo laboratories. These processes designed to ensure on time delivery to appropriate quality in both GMP and non-GMP options.
Preclinical & Phase 1
Process Development:
Unit Operation Studies:
Process Safety & Hazard:
Software Tools:
