Search results for " patients"
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
EMA Collaborates with HTA Assessment Networks
This has helped to overcome concerns among Danish patients about production standards with biosimilars. Within less than two years, biosimilar somatropin, the growth hormone, rose from a market share …
Article
Elucidating Biosimilars Characterization
…e; however, depending on the mechanism of action of the protein, such a study may need to be done in patients. Although it may be possible to carry out such a study in healthy volunteers, the product…
Article
Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
These drugs improve quality of life for our patients and reduce the burden on the healthcare system.
This trend towards higher concentration is a challenge for existing filters due to the higher p…
Article
Report from the 12th Plasma Product Biotechnology Forum
…made by FDA during the pandemic - have significant global impact for plasma fractionators as well as patients. Hence, PPTA stressed the importance of science based and harmonized regulatory guideline…
Article
Assessing Manufacturing Process Robustness
Figures courtesy of the authors
A cause-and-effect technique is utilized to identify underlying factors that could have an impact on CQA that would affect patients…
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …
Article
A Look into the Future of Biopharmaceutical Quality
These complex therapies have evolved, and with this evolution comes new challenges in ensuring the quality of these products and the safety of the patients that use them. Quality regulations, and indu…