Search results for " continuous"
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies, along with continuous processing approaches, are helping the industry both modernize old processes and facilities and minimize the risks associated with making sig…
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Modern Manufacturing Systems Key to FDA Quality Initiative
She reiterated this approach at the February 2015 annual meeting of the Generic Pharmaceutical Association, urging development of continuous manufacturing operations that can achieve consistent produc…
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Technologies and Practices Must Evolve to Meet Demand
Continuous advancement
The survey responses reveal that continuous manufacturing currently is not used widely, but bioprocessing experts surveyed are optimistic about its future use. Less than one…
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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The Future of Biopharma
…i-product facilities
• adoption of single-use systems at clinical and commercial scale
• continuous processing, including perfusion
• high-tech expression systems and other genetic engine…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Adoption of advanced PAT tools not only improves process monitoring and control, but enables process intensification strategies, including continuous manufacturing (perfusion), in both adherent and su…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Those process analytical technologies (PAT) are a critical part of control strategies that ensure continuous operation within the design space.
While …
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Good Manufacturing Practices: Challenges with Compliance
Having an effective feedback loop from multiple sources, such as regulatory inspections and customer audits, makes it easier for companies to continuously improve their CGMP practices. I have also fou…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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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…