Search results for "scale-up" in Articles / App Notes
Article
Single-use Bioreactors Have Reached the Big Time
…ell therapy equipment and reagents to support next-generation technologies for new drugs, including scale-up models; regionalizing single-use manufacturing platforms for biologics (increasing local p…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
…rum that continuous processing, ripe with innovation, will result in better quality products, fewer scale-up risks, and long-term economic advantages.
Last year also marked a significant step tow…
Article
Improving Process-Scale Chromatography
By providing a single platform to connect data, technology transfer and scale-up from process development to final manufacturing scale are also simplified. “The benefits can be even greater when data …
Article
Perfusion in the 21st Century
The use of smaller bioreactors, even for commercial production, reduces the time and cost required for scale-up (7). Finally, perfusion can accommodate the shift toward multiproduct facilities, which …
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
What patterns are you seeing in the use of single-use systems for scale-up and commercial production for CMOs versus drug companies that manufacture their own products?
Commercial-scale bioprocess…
Article
Innovative Therapies Require Modern Manufacturing Systems
At the same time, though, the development of such innovative and targeted therapies heightens the importance of establishing production systems and processes capable of fast scale-up of high-quality c…
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Taking a “Development-by-Design” Approach to Cell Therapies
Invetech has been working on cell therapy process scale-up automation for more than 10 years and has successfully completed projects in North America, Europe, and Asia for companies that include Argos…
Article
Quality Systems Key to Lifecycle Drug Management
This plan will allow the original reviewers to evaluate initial scale-up and formulation changes for more innovative products. Post-approval changes for biotech therapies will continue to be managed b…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such approaches, the authorities predict, could reduce waste, prevent drug shortages, and avoid the scale-up and production challenges that can delay final approval of innovative breakthrough therapie…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…sers, and there are also concerns surrounding process development control, contamination risks, and scale-up potential of traditionally batch-based systems (1). In addition, there is some trepidation…