Search results for " control"
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
By Jill Wechsler
While cell- and gene-therapy products hold the promise of transforming the treatment of many diseases, difficulties in achieving consistent process control could sty…
Article
Biopharma Seeks Balance
While the business, economic, political, and regulatory perils may be difficult to predict, science and technology can give biopharma more control and predictability over drug development and manufact…
Article
Challenges in Cell Harvesting Prompt Enhancements
Coupled with head pressure applied to the bioreactor, a completely sealed system such as this allows the flow to be controlled at the outlet of the machine, which removes the need for pumps and flow-c…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
… sterilized filling components, fill/finish processes are heavily dependent on technique, equipment, controls, and having detailed procedures (1).
Handling sterile liquids in the pharmaceutical i…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Several published articles have evaluated the use of visual inspection procedures and the role of visible cleanliness in control of critical variables, as well as establishing visible residue limits o…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
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…