Search results for " start"
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EMA Collaborates with HTA Assessment Networks
But they are also starting to cover types of formulation and manufacturing processes particularly when gauging cost effectiveness. National bodies do not always carry out assessments but they are also…
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Implementing QbD in Sterile Manufacturing
This is important to control the results of the former activities, as well as to identify and solve any existing problems prior to the start of the drug-manufacturing process. We primarily execute a d…
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Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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Evolution of the Monoclonal Antibody Purification Platform
It has been more than a decade since the industry started establishing the process platform. This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the puri…
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State of Quality and Compliance in the Biopharmaceutical Industry
Instead, it must be a collaborative effort across all functional areas starting with each individual employee. This is particularly true in manufacturing, where they are the experts in the technologie…
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FDA Seeks Metrics to Define Drug Quality
In its comments, Pfizer describes four levels of quality performance indicators, starting with staffing adequacy, workload, and increased turnover. Further signals of potential quality or compliance i…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As this new class of biologic medicines is introduced into healthcare systems worldwide, there must be an uncompromising commitment to patient safety, which starts with high regulatory approval standa…
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Report from India
Enhanced focus on over-the-counter products, vaccines, and biosimilars would start gaining importance in overall business strategies. Companies will look at in-licensing initiatives, comarketing, and …
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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QbD and PAT in Upstream and Downstream Processing
The starting point for the risk assessment is R&D, which upstream has determined the CQAs on the product. CQAs are often product specifications, including eventual GMP requirements (if GMP is used as …