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Technology transfer is integral to the lifecycle of virtually every pharmaceutical product. Tech transfer enables a product to advance from the development lab into clinical manufacturing and then scale-up to commercial production. As demand grows, tech transfer is instrumental in adding additional manufacturing capacity at locations across the globe. Tech transfer may involve site-to-site transfers internal to a sponsor company, transfers between a sponsor company and a CMO (either direction), or from one CMO to another CMO (in or out of network). It is not unusual for a product to undergo multiple tech transfers during its lifecycle.<\/span><\/p>\n <\/p>\n The success of a tech transfer is measured in terms of meeting quality, regulatory, and business goals. From a quality standpoint, the product produced at the receiving site must satisfy the same critical quality attributes (CQAs) as the product produced at the sending site. From the regulatory perspective, the sponsor company must obtain regulatory approval to market the drug produced by the receiving site. From a business perspective, a tech transfer project must meet the sponsor\u2019s objectives in terms of cost, schedule, resources, and scope.<\/span><\/p>\n <\/p>\n Technology Transfer Best Practices<\/span><\/strong><\/span><\/p>\n In the video below, Beth Haas, CAI Principal Consultant and expert in tech transfer, discusses tech transfer best practices with Charlie Maher, CAI\u2019s Global Director for Process and Manufacturing Technologies.<\/span><\/p>\n <\/p>\n
Technology Transfer Success Factors<\/strong><\/span><\/p>\n