Search results for " control"
Article
Single-use Bioreactors Have Reached the Big Time
Automation and process control, both of which are essential to enabling consistent and reliable biomanufacturing, have improved greatly for single-use bioreactors as well. “Historically, single-use te…
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Ensuring Sterility in Small-Scale Production
For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Asso…
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Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
This test compares the spectrum of each media with the spectrum of each corresponding control and was successfully employed for identification of different types of growth media with diverse formulati…
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Biopharma Advances Demand Specialized Expertise
The complexity of product changeovers is reduced by single-use technology, which decreases the need for clean-in-place, steam-in-place, and quality control testing. Typically, line clearance time is r…
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Challenges in Analytical Method Development and Validation
So at this point, it is important to have confidence in the method and its ability to be transferred from R&D to quality control or, in some cases, to a contract organization that will be doing the te…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Key considerations such as LEAN, multipurpose and flexibility was designed and built in to the facility from start, ensuring high capacity, microbial control and tracing of all filled vials. During th…
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A Look Ahead at BioPharma Manufacturing and Regulation
FDA is currently pursuing additional pathways to ease postapproval changes for well-understood and controlled processes under a robust quality system.
Continuous manufacturing, althoug…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
… data is in a pilot-plant environment, it has to find its way onto a historian or some other process control and monitoring system within the commercial or development laboratories where they're coll…
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Implementing Inline Conditioning to Advance Process Intensification
Looking into the future, are there some aspects of the IC technology you want to investigate further, or intend to implement next?
We validated and used in GMP batches IC technology by flow cont…