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The complex set of activities involved in technical transfers of pharmaceutical innovations from research laboratories to clinical and commercial manufacturing is one of the most critical, yet challenging, steps in the drug development process. If product and process knowledge is not exchanged correctly and efficiently, it could result in delays and failures that significantly impact the overall success of the product. Therefore, an effective strategy is essential for facilitating these transfers, as this will help accelerate the translation of projects from bench to market.
As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Thus, our team has designed a modular, yet flexible, approach to tech transfers that can successfully support progression from product development to clinical trials and, ultimately, commercialization. It is consistently structured and documented globally across all Lonza sites, so the experience is the same, regardless of which facility the transfer takes place in. Lonza’s approach is designed to provide a detailed understanding of the product and process so that each module stage adds value to the final development and manufacturing process eventually used for commercial launch and supply. New and innovative technologies are introduced whenever possible in order to increase yield, improve throughput, and reduce the cost of goods. The modular approach is also considerate of regulatory expectations during the product life cycle and takes those into account during any changes and/or modifications.
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