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
… 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
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…
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
Regulatory constraints
Regulatory restrictions may exclude some cell-detachment methods from consideration in particular applications or require extensive validation before authorization of use is…
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
Regulatory agencies understand that it is difficult to pinpoint MOA.”
Preti emphasizes the importance of working with regulators. “You can be in a position to inform and influence regulations as p…