Search results for "EMA"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Three products are indicated against cancer and a further two against genetic diseases, while the remainder target a wide range of medical conditions.
In terms of expression systems use…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
This past decade has seen both the titers and cell densities increase by an order of magnitude to meet the clinical and commercial demands (4–6). Further, companies have made significant investments i…
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Bracing for a Future Wave of Advanced Therapies
Investment into this sector was nearly $12 billion for the year, which Hunt noted in the industry briefing as being slightly down compared to 2022, but that commitment to the development of CGTs remai…
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Genetic Vaccine Platforms Demonstrate Their Potential
Live viral vaccines may also be challenged with stability issues and require frozen temperatures to remain viable and potent.
Similarly, a viral vector-based vaccine can cause an …
Article
Reimagining Affordable Biosimilars
…pecificity in protein–protein interactions for the treatment of complex diseases such as cancer, hematological disorders, and autoimmune diseases (1).
The development of protein therapeutics, ho…
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An Analytical Approach to Biosimilar Drug Development
As a result, demand has increased for chromatography and mass spectrometry technology providers to design instrumentation, software informatics, and workflows to support protein analysis studies. In a…
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Putting Viral Clearance Capabilities to the Test
EMA, Notes for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, CHMP/BWP/268/95, London, Feb. 14, 1996. …
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The European Medicines Agency (EMA) started approving biologics well before the US, and approved 22 biosimilars by the end of 2016.
Unlike a small-molecule drug, however, a biologic drug can’t be …
Article
Innovation vs. Capacity: How CMOs Compete
…support dependable registration and approval of new drugs at FDA and the European Medicines Agency (EMA)
• Capabilities to support clients on a global scale, especially clients in North America, …
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
During this period of explosion in the application of CHO expression systems, considerable efforts have been made to improve recombinant protein production to meet the demands of high quantity and con…