Search results for " GMP"
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA officials say they are open to considering alternative proposals from manufacturers for GMP compliance and advise firms to indicate clearly in submissions how multiple facilities aim to achieve st…
Article
Best Practices for Data Integrity
If manufacturing data are missing or inaccurate, then the firm is in violation of GMP regulations; it may mean that the quality of the product cannot be trusted. In serious cases, bad data integrity c…
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…
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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…
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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…
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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…
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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 …
Webcast
Webcast: On-demand virtual demo of ÄKTA ready™ 450 single-use chromatography system
Learn more about the latest addition to our family of single use chromatography systems and how this will enable you to better purify small volumes in a GMP environment.