Search results for " control" in Articles / App Notes
Article
Efforts Accelerate to Streamline Postapproval Change Process
Ridgway described a continuum of ECs, including specifications, raw materials, in-process testing and controls, critical hold times, and manufacturing process elements. While changes in an EC normally…
Article
Perfusion in the 21st Century
Regulatory agency interest in the greater process control and product consistency afforded by continuous manufacturing (8) is also generating more attention around perfusion technology.
As perfusi…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
In these cases, it is important to control the temporal resolution of the cell-detachment technique.
Compatibility with sterilization methods
In case sterilization of the cell culture device i…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
…can precursors; cell viability, as dying cells release degradative enzymes; and the level of process control.
Bioreactors offer much greater control of pH and dissolved gasses than shake flasks do…
Article
Best Practices in Qualification of Single-Use Systems
• “Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer…
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
Robust Optimization, Simulation, and Effective Design Space
Define the effective design space used for process control and define the purpose of the design space.
Steps 7–12 will be discussed in detail in this paper.
Figure 1: Robust optimization…
Article
Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
Article
Re-use of Protein A Resin: Fouling and Economics
The controlled pore glass-based Protein A resin from EMD Millipore (ProSep) has better flow characteristics and diffusional properties than agarose-based Protein A resins (13). However, it suffers fro…
Article
Challenges and Trends in Biopharma Facility Design
Quality control and building standards are also essential, with a view to meeting [European Medicines Agency] EMA, FDA, [Chinese Food and Drug Administration] CFDA, and other regulatory standards for …