Sterile APIs

Our experts provide a complete range of synthesis capabilities for sterile API projects, from raw materials through regulated early- and late-stage intermediates to bulk APIs. We also offer advanced building blocks based on proprietary, leading technologies that we use in these synthesis situations. Sterilization capabilities can be integrated with API production or serve as an outsourced step if you need additional capacity or do not have bulk sterile facilities. Our dedicated facilities are located on sites with a range of flexible chemistry capabilities that allow the handling of hazardous reagents in chemical syntheses. This enables us to integrate API synthesis to make the overall synthesis and process chain more efficient.

Microfiltration

Our scientists apply high-performance microfiltration to accomplish sterilization. We often use this technology with powder, which is dissolved, filtered and crystallized. Microfiltration differs fundamentally from traditional sterilization methods in that it is nondestructive. We offer many techniques to precisely control the physical properties of the final product.

Quality Assurance

We bring more than a decade of experience creating the appropriate conditions for the media fill and process validation for sensitive and difficult-to-handle products. Our QA follows the strictest FDA, ICHQ7A and ICHQ1A guidelines, and our quality control team determines all relevant parameters. Our plant, particularly in the aseptic processing area, employs a system of airlocks and cleanroom zones from class D through class A in the product zone.

AMRI offers several sterilization techniques:

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