• Corpus ID: 207766894

Wet Test Runs Technology Transfer Using Engineering , ShakeDown , and Strategies for Maximizing Successful Drug Substance

@inproceedings{Bain2015WetTR,
  title={Wet Test Runs Technology Transfer Using Engineering , ShakeDown , and Strategies for Maximizing Successful Drug Substance},
  author={David Bain and John Bowers and Victor Larivee and Jasmina Xie},
  year={2015}
}

• David Bain, John Bowers, +1 author Jasmina Xie
• Published 2015
• Business

The technology transfer of biological products is a complex process requiring control of multiple unit operations and parameters to ensure product quality and process performance. To achieve product commercialization, the technology transfer sending unit must successfully transfer knowledge about both the product and the process to the receiving unit. A key strategy for maximizing successful scale-up and transfer efforts is the effective use of engineering and shake-down runs to confirm operational performance and product quality prior to embarking on good manufacturing practice runs such as process performance qualification runs. We consider key factors to consider in making the decision to perform shake-down or engineering runs. We also present industry benchmarking results of how engineering runs are used in drug substance technology transfers alongside the main themes and best practices that have emerged. Our goal is to provide companies with a framework for ensuring the “right first time” technology transfers with effective deployment of resources within increasingly aggressive timeline constraints. Introduction As many biopharmaceuticals start to hit the patent cliff, companies face the immense challenge of improving their efficiency in developing and commercializing their pipeline. A key component of this objective is ensuring efficient technology transfer from research and development (R&D) to manufacturing operations. Figure 1 illustrates the key drivers that need to be balanced to ensure successful technology transfer: quality, technical, and business considerations. Ultimately, the technology transfer is considered successful by achieving “right first time” with successful lot release and a minimal number of nonconformances or out-of-specification (OOS) events. To demonstrate the effectiveness of the process scale-up and transfer, we need to analyze the critical process performance parameters, alongside the targets for product quality attributes and process yield and the ability to control within defined operating ranges. The quality and technical drivers need to be achieved against the backdrop of the business constraints. These include schedule and on-time delivery of the product for clinical trials and product launch, and financial and resource considerations. In the first article of this series on technology transfer, we outlined the key elements of a robust technology transfer business process. In this article, we review some of the key strategies used to ensure successful technology transfer, focusing particularly on the use of engineering, shake-down, and wet test runs. There is debate in most companies on whether a test run is required to shake-down the process and equipment, confirming product quality prior to starting current good manufacturing practice (cGMP) manufacturing runs intended for human use in clinical studies or as commercial for-sale products. This would be analogous to the production of a prototype in, say, the automobile industry: Would you buy a car and accept the risk of driving your family in the prototype car that just came off the assembly line? The benefits in terms of identifying and rectifying potential issues in the *Corresponding Author: David Bain, Facilitator, BioPhorum Operations Group (BPOG) Corresponding author contact information: BPOG, 5 Westbrook Court, Sharrow Vale Road, Sheffield, S11 8YZ, United Kingdom. e-mail: [e-mail] This is the second in a series of articles from the BioPhorum Operations Group member companies, discussing various aspects of drug substance technology transfer. In this article, we review the use of shake-down, engineering, and wet test runs to maximize the success of drug substance technology transfer efforts. doi: 10.5731/pdajpst.2015.01087 BPOG SPECIAL SECTION: The following article is a special editorial contribution from the BioPhorum Operations Group (BPOG). Please note that it did not go through the PDA Journal and Pharmaceutical Science and Technology regular peer review process. 650 PDA Journal of Pharmaceutical Science and Technology on December 8, 2016 journal.pda.org Downloaded from