On-Demand Webinar

Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds

Duration: 1 Hour
Speakers: Janmeet Anant, Regulatory Advocate and George Adams, Director of Marketing for Provantage® Laboratory Services, Merck

Abstract: Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans. This typically includes information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. Providing this information for investigational medicines can be more complex where the manufacturing process may not yet be fully defined. Sterilizing filtration should be qualified during early clinical phases to demonstrate that it is effectively providing a sterile product without adversely affecting its properties. The filter, as critical equipment used for manufacturing sterile phase 1 investigational drug, should not contaminate or otherwise react with, add to, or be absorbed by the drug. In order to assess its performance and thereby ensure the quality of the product, several aspects have to be examined including bacterial retention, chemical compatibility, extractables and adsorption. Based on our experience at Merck, you will learn about the key elements of sterile filtration validation, along with understanding more about global regulatory guidance for developmental phase drug products.

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