Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
News|Articles|May 15, 2017
- Pharmaceutical Technology-05-15-2017
- Volume 2017 eBook
- Issue 1
Cost Considerations Drive Lean Technology in Biomanufacturing
Author(s)Catherine Shaffer
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
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The approval of biosimilars for the US market has created a need for more efficient manufacturing processes.
Manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products manufactured with legacy processes.
Innovations include more productive cell lines, single-use systems, and powerful analytical methods.
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Articles in this issue
over 9 years ago
Clean, Disinfect, and Validateover 9 years ago
Kill the Bioburden, Not the Biological Indicatorover 9 years ago
Ensuring the Biological Integrity of Raw Materialsover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
Case Study: Retrofitting Two New High-Purity Water Systemsover 9 years ago
Single-Use Bioreactors Have Reached the Big Timeover 9 years ago
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