Get insights on Technology Transfer by Design

We just found this article from April 2017 and wonder if this is a real topic for the pharmaceutical industry and what is the situation actually.

 

Accelerating trends in the pharmaceutical industry have made successful technology transfer more critical than ever. Mergers, acquisitions, the rise of generics, the closing of plants and the construction of new ones — these trends and events typically entail the transfer of products and processes from one site to another. New products, too, must often be moved from the development site to a manufacturing site prior to launch. 

 

Accelerating trends in the pharmaceutical industry have made successful technology transfer more critical than ever. Mergers, acquisitions, the rise of generics, the closing of plants and the construction of new ones — these trends and events typically entail the transfer of products and processes from one site to another. New products, too, must often be moved from the development site to a manufacturing site prior to launch. 

 

Technology transfer becomes even more challenging when several dozen products must be transferred at the same time and in parallel, as often happens following a merger, acquisition, or alliance, the closure of a facility, or the need to quickly develop and manufacture a large number of generic drugs. Cost pressures, market needs, government regulations, tax benefits, and logistic issues have also greatly magnified the importance of technology transfer.

 

The decision and plan for technology transfer is a direct result of several factors, such as corporate vision and business requirements, sourcing and manufacturing strategies, and the overall company strategy. All of these parameters together dictate the site and product transfer strategies and plans.

 

With these trends likely to continue for the foreseeable future, companies can no longer afford to treat technology transfer as something that “will get done anyway.” Whether transfer takes place between two sites, two companies, a company and a third-party manufacturer, or even from R&D to a pilot plant or commercial facility, the ability to do it faster, more compliantly, and less expensively can confer significant competitive advantages. Successful companies will therefore make technology transfer a core competency to ensure that they can compete effectively today and in the future.

 

They can establish this critical core competency through Technology Transfer by Design (TTbD), based on the principle that technology transfer is a process that can be designed, improved, and controlled, much like other processes. Just as at the product level, where Quality by Design (QbD) depends upon an understanding of the interactions in manufacturing processes of multiple variables that keep the resulting product within specifications, TTbD at the portfolio level provides a systematic way to understand all of the elements that go into the design of the tech transfer process and ensure that they stay in synch to produce a successful transfer.

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