Search results for "regulatory"
Article
Contract Manufacturing Through the Years
…evenues; they have the most advanced technologies, deepest development capabilities and most global regulatory and compliance experience. That gives them the most pricing power and makes them the mos…
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From Darwin to Recombinant Fc Multimers
… to monitor manufacturing performance, and also contributed to the process control, validation, and regulatory activities.
The third day of the conference opened with the Pathogen Safety session…
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Single-use Bioreactors Have Reached the Big Time
“Previous concerns over business continuity and the regulatory requirements relative to implementation have been addressed, and there are now proven solutions available for customers,” he comments.
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Ensuring Sterility in Small-Scale Production
… the suitability of your processes, you should be able to produce any size batch in accordance with regulatory expectations.
References
1. FDA, Guidance for Industry, Sterile Drug Products …
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Advancing Single-Use Technology Through Collaboration
In addition, manufacturers had been generating their testing methods for single-use systems by extrapolating from their interpretations of the regulatory requirements for traditional systems. In order…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Reporting Quality Metrics to FDA
Measuring quality metrics is not only important because it is becoming a regulatory expectation, but because it is good practice to have in place for the benefit of your company. Therefore, it is impo…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Regulatory constraints
Regulatory restrictions may exclude some cell-detachment methods from consideration in particular applications or require extensive validation before authorization of use is…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Test procedures and acceptance criteria for CQA analysis have been described in regulatory guidelines for biotechnological/biological products (6, 7).
Late-stage development starts with set up and…
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Fluid Handling in Biopharma Facilities
The fluid handling process will be defined by regulatory compliance, economics, safety, sterilization, risk management, process control, automation, productivity, cleanliness, and flexibility. For exa…