Search results for " facility" in Articles / App Notes
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Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
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Raw Material Variability
The focus of attention needs to be outside the walls of the bioprocess facility (i.e., at the supplier’s plant) as well as in the bioprocess. Raw material supply chains are complex and multi-tiered. R…
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Q&A with Industry Leaders: Rita Peters
This week, Process Development Forum's new Q&A feature interviews Rita Peters, Editor of BioPharm International Magazine, about second quarter trends in drug development.
Q: What trends have yo…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished produ…
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EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
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2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
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Supplier-Change Management for Drug-Product Manufacturers
Material Distributor or Warehousing
• Use of a new facility for storage or distribution of materials
• Change in processes or qualified equipment impacting storage and distribution of product …
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State of Quality and Compliance in the Biopharmaceutical Industry
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning letters, and consent decrees resulting from facility inspections. Th…
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Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…