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Technology Transfer
Transfer of biologics manufacturing processes is a challenge with complexity and high risk. A solid and experienced CDMO partner with efficient procedures and proven workflow is crucial to ensure a smooth and successful technology transfer.
Wacker Biotech has experience in transfer of processes at different stages of the product lifecycle. Depending on the stage of your product and your current needs, we perform transfer and further development of early stage processes or transfer of commercial products to one of our 5 GMP facilities.
We transfer processes at any development or lifecycle stage of your clinical or commercial product. We are able to:
- Transfer and further develop early stage products
- Mirror production of commercial products to extend your manufacturing capacity
- Establish a backup strategy for production to ensure an adequate market supply
- Scale up to increase manufacturing batch sizes with enhanced efficiency
- Scale down depending on your needs
A dedicated and experienced team with members from all involved areas is crucial. The core team including MSAT, process development, production, quality control and quality assurance coordinates and executes together with a dedicated project manager all transfer activities.
The ultimate goal is to achieve state-of-the-art processes with regulatory compliance, minimized risk, and short timelines, while keeping within cost projections.
