Search results for " regulatory" in Articles / App Notes

Article 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. …

Article Ensuring Sterility in Small-Scale Production
…e 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…

Article 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…

Article Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
It was decided with support from various regulatory agencies to make every effort to avoid sources that were known as potential hosts for human pathogens, such as bovine sources, and also to require s…

Article 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…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Strong regulatory considerations are also associated with the use of enzymes in biopharmaceutical applications. On the other hand, this method provides an efficient way to disrupt cell-to-cell interac…

Article 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…

Article 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…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
The quality of an API is intrinsically related to the cleaning procedure employed; therefore, this aspect needs to be adequately addressed by the manufacturers and deeply reviewed by regulatory author…

Article Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015 By Agnes Shanley BioPharm International eBooks Volume 28, Issue 13 Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…

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