Search results for " GMP" in Articles / App Notes

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Raw materials Raw materials have been regarded as one of the main portals of viral entry into a GMP manufacturing environment. The main goal of viral risk mitigation at this level is to pr…

Article Lessons Learned Accelerate Vaccine Development
The first GMP batch of its Ebola vaccine regimen was produced in October 2014 in a 2 x 10-L setup at its research center in Leiden, The Netherlands. Since then, the company has produced and frozen 2.4…

Article Modular Manufacturing Platforms for Biologics
Modular bioprocessing facilities may be best suited to countries that struggle with GMPs. Pods, in particular, may be especially useful for emerging markets, points out Emel, “where local construction…

Article Pharma Investments Reflect Key Industry Trends
Eli Lilly: The $450 million, 240,000-square-foot biologics facility in Kinsale, Ireland that Eli Lilly announced in 2012 is expected to be complete by the end of 2014, with the first production of GMP

Article Challenges in Analytical Method Development and Validation
Guo (FDU): The analytical methods need to be validated for any GMP activities. This is a GMP requirement as well as FDA expectation. The analytical methods should be properly validated even to support…

Article Manufacturers Struggle with Breakthrough Drug Development
This involves assessing timelines around formulation and process validation and ensuring that all manufacturing sites are GMP compliant. If there are no changes in formulation, it may be easier to lev…

Article QbD and PAT in Upstream and Downstream Processing
CQAs are often product specifications, including eventual GMP requirements (if GMP is used as part of the biopharmaceutical process, which is often the case in multinational pharma companies in order …

Article Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
In a validated GMP process, filters must be routinely tested for integrity. The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. …

Article On-demand: ÄKTA process™ system virtual demo
Improving usability, efficiency, and reliability were our focus when we designed the new ÄKTA process™ system. In this virtual workshop Torbjörn Blank will explain how the ÄKTA pr…

Article How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…

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