Search results for " pharmaceutical" in Articles / App Notes
Article
Early Communication with Regulators is Essential for SMEs
Among the EU’s regulatory agencies in pharmaceuticals, the most active in championing innovation has been the European Medicines Agency (EMA), which is responsible for centralized approvals of medicin…
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Looking at various International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q10, Q9, Q8, going back into the pharmaceutical development, it depends on where …
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Addressing the Complex Nature of Downstream Processing with QbD
These steps combine to build quality into pharmaceutical processes and products over the lifecycle of a pharmaceutical product.
The industry has been slowly adopting the QbD approach, but with the…
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Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…
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Biopharma Seeks Balance
Big Pharma spinoffs, startups, virtual companies, industry-academia partnerships, and a growing contract services market contribute to the changing landscape of the pharmaceutical industry.
Glo…
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Roadmap Leads to Innovative Biomanufacturing Strategies
…ndependent consultant who previously served as director of cell culture process development at Shire Pharmaceuticals.
Different perspectives
BioPharm: Why is it important to have the different…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The preferred materials of construction in the pharmaceutical industry are 304 and 316L stainless steel. Other materials of construction are used throughout the industry. The selection of materials sh…
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Efforts Accelerate to Streamline Postapproval Change Process
And by encouraging greater reliance on pharmaceutical quality systems (PQSs) and change management protocols, policy makers hope to prevent drug shortages, while also reducing the time and cost involv…
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Managing Biomanufacturing Capacity Expectations
A 2007 article in Pharmaceutical Executive estimated that a launch delay costs an average of $15 million per drug per day (4). This number changes, however, depending on the market demand of the drug …