Search results for " start" in Articles / App Notes
Article
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 …
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
This necessitates a formal plan at the start of the development program, and both the CMO and the client need the commitment to do the work upfront. This strategy enables a seamless transition when th…
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Flexibility in Biopharmaceutical Manufacturing
The choice between stainless steel and single use is influenced not just by the economics of batch size and cost of goods but also by the speed by which processes can be configured and started up. Thi…