Search results for " start"
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Mechanistic Modeling: Does it Have a Future in Process Development?
An essential part of the discussions with the regulatory agencies was process understanding and at that time, we had started using mechanistic modeling. So, we wanted to show them a case where mechani…
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Trends in Single-use Bioreactors
Sherman (Sartorius): The same benefits of single-use will apply to continuous processing that apply to batch processing: low capital costs, faster start-up, and fast process changeover. However, there…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Is QbD activity company-wide or occurring within smaller groups in the company?
QbD implementation started off as something that smaller groups would get involved with. However, as these concepts h…
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Healthcare Reform in China
Healthcare providers such as Singapore-based Raffles Medical Group and US-based Chindex International have started operations in China.
Investors, however, have a string of issues to contend with.…
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Relationship Building at Top of Mind for Clients
As a result, it can take three or more months to build a rapport and start a project. And as the BioPlan study indicates, these first few months are crucial for both parties to build trust and a sound…
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Single-Use and Continuous Processing Technologies Change Facility Design
Facilities in use today and built during the past decade would easily be recognised by the original engineers who started this industry in the mid-1970s, whereas facilities designed now are beginning …
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Applying GMPs to the BioPharma Supply Chain
BPOG Checklist
The starting point for helping transform the inbound supply chain is to define and articulate what these best practices are and to set out a road map for their implementation. With …
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Q&As with Industry Leaders
…Nagle, Staff Technical Operations Engineer, Janssen
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Gunnar Malmquist, Senior Principal Scientist,…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Continued process verification is the recognition that process validation is a lifecycle that does not end with PPQ and the start of commercial production. In exchange for CPV, FDA will allow changes …