The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option.
With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner.
China is quickly becoming a world leader in biopharma, with rapid build-out of gene and cell therapy production capacity and a robust pipeline of drugs in development.
PODs provide the environments for the entire upstream and downstream process for a state of the art gene therapy facility.
Flexible and modular facility designs that can be built in a factory, shipped to the site and then rapidly assembled have been recognized and are being addressed by innovative suppliers.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.
If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
Helping your cell therapies succeed through our reach and resources.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error. The connectors’ robust construction provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical manufacturers benefit from interchangeable 3/4” and 1” flow solutions for full-scale bioprocessing production environments with the quality and market availability they expect from the leader in single-use connection technology.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error.