The implementation of single use technology in GMP manufacturing is growing rapidly. This is primarily because of the increased yields available using disposable technology, the growth of biosimilar approvals and the acceptance of personalised medicines. Single-use equipment trains are also enabling innovative start-ups and contract manufacturers to rapidly produce clinical trial material, monoclonal antibodies (mAbs) or cell and gene therapies.
Both upstream and downstream manufacturing processes benefit from single-use systems. They allow manufacturers to quickly add capacity at lower costs. They also make multiproduct GMP manufacturing easier to implement allowing facilities to respond quickly to changing supply demands. The benefits of single-use technology are numerous. They include lower capital cost, greater flexibility, lower environmental impact as well as more efficient and faster turnaround for smaller batches due to avoidance of cleaning, sterilization and validation prior to usage. Single-use technology adoption has led to reductions in capital investment by as much as 25–30% in some cases and increased speed to market by as much as 60%.
Ultimately, single-use is an agile technology that offers patients around the world better access to existing medicine and enables manufacturers to deliver these therapies faster, in a more personalised way. In relation to drug manufacturing traditionally when a batch is lost there is monetary losses, in cell and gene therapy if a batch is lost this can potentially result in patient fatalities.
- Strong process expertise in single use and associated automations
- Automation & MES consultancy services including functional design
- System Integration
- CSV and document structures, support coding and design guidelines
- Historian for process analytics
- Internal testing and facility commissioning and qualification support
- System support after go-live
Zenith prides itself on being vendor independent and although we have a lot of experience utilising different single use technologies, we use the best possible solutions based on our customers’ requirements. Get in touch with us to talk about your single use requirements today.
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