Search results for " contamination"
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Single-use raw material delivery systems, in powder or liquid form, can help reduce the risk of contamination and minimize the need for frequent cleaning steps. Raw material quality control (QC) testi…
Article
Gene Therapies Push Viral Vector Production
“Scale-out of these systems result in more laboratory handlings and, subsequently, a higher failure rate due to contaminations,” Touw says.
“This can be prevented by implementing a novel fixed…
Article
Understanding Validation and Technical Transfer, Part I
The contamination was found to be due to problems with the autoclaves used to process terminally sterilized parenterals (2).
From 1970-1973, a series of septicemia events in hospitals throughou…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Sampling sites should be defined based upon the geometry and design of the equipment, materials of construction, hard-to-clean areas, and locations that may have a higher risk to product contamination…
Article
Defining Risk Assessment of Aseptic Processes
… sterile core area and the areas supporting it are properly maintained at all times to avoid product contamination that would impact patient safety.
Developing a risk-based approach
The first…
Article
Real Time Continuous Microbiological Monitoring
It is not possible, however, to clearly distinguish between background total particulate contamination generated largely by mechanical operations and the total particulates contributed by personnel. T…
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Gowning Practices Provide Clues to cGMP Compliance
Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards (1).
In a new facility, t…
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In-person seminar: Manufacture of sterile medicinal products
Are you developing a Contamination Control Strategy? Join us for a free in-person seminar focused on applications at the end of the bulk drug substance workflow including drug product applicat…
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Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
These advantages, according to Atul Mohindra, senior director of R&D for Lonza, drive down overall contamination rates as well as enhance the efficiency of a production facility while reducing manufac…