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PRODUCT SAFETY AND QUALITY

Quality processes for safe medicines

Mabion`s intent to successfully control the quality of the biotechnological drug is reflected by the set of in-process controls, including specifications at multiple levels of manufacturing process steps: raw material specification and release criteria for product at process stages, as well as final drug product release specification. All analytical methods were designed to focus on critical quality attributes necessary to control during manufacturing steps, which are reflected in product quality, safety and efficacy demonstrated during clinical development.

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