Technology Transfer and the Product Lifecycle
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.
Technology Transfer Success Factors
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’s objectives in terms of cost, schedule, resources, and scope.
Technology Transfer Best Practices
In the video below, Beth Haas, CAI Principal Consultant and expert in tech transfer, discusses tech transfer best practices with Charlie Maher, CAI’s Global Director for Process and Manufacturing Technologies.
Your Partner in Technology Transfer
CAI has extensive experience in planning, leading, and delivering tech transfer projects for our clients. We have managed tech transfers for all types of life science products, at all phases of the product lifecycle, and for all types of sending and receiving sites worldwide. We have a strong track record of delivering successful projects, meeting all quality, regulatory, and business objectives.
We want to learn more about your tech transfer plans and discuss how CAI can help you realize success in your upcoming tech transfer!
About the Authors
Beth Haas is a Principal Consultant with over 25 years of experience supporting commercialized products across a variety of industries. As a tech transfer program manager, Beth uses her skills in product development, process engineering and risk management to lead global cross-functional teams with energy and focus on the business goals.
As Global Director of Process and Manufacturing Technology, Charlie Maher leads CAI’s delivery of solutions that advance life science products through their lifecycle. Services include: Product development/QbD, development to clinical to commercial manufacturing scale-up planning/management, process and facility conceptual design, tech transfer, process validation, CMC regulatory support, in-service process engineering, aseptic processing, investigations and issue resolution, and supply chain management.