Validating the safety of biological preparations requires thorough testing for contamination by adventitious agents. Utilizing mammalian cell cultures to produce recombinant proteins as biopharmaceuticals requires testing for viral contamination. The polymerase chain reaction (PCR) may be employed to specifically detect the presence of viral DNA or RNA with great sensitivity. PCR assays are particularly useful for the qualification of recombinant cell banks. Regulatory agencies recommend that mammalian cell banks be tested for a variety of possible human viral contaminants. In most cases the cells used to produce the cell bank have been previously analyzed for viral contamination. The use of PCR for the detection of viruses in the final banked cells can alleviate the need for difficult, costly, and time-consuming infectivity assays. In some cases the relevant viruses cannot be cultured, eliminating the ability to perform infectivity assays. The PCR assay can provide a sensitive and specific method for detection of viral contamination when standard infectivity assays are unsatisfactory…
Tag: <span>PCR- based assay</span>
The safety of our food supply is a major public health concern for consumers, government regulatory agencies, and the food industry. Earlier generations may recall when fresh produce was largely domestic and seasonal. Today we live in a global marketplace, where fresh fruits and vegetables may be on the vine overseas one day and on our grocerās shelf the next. Although this has provided more yearround variety of foods for the consumer, a lack of uniformity in established agricultural standards and practices among international trading partners (e.g., sanitary issues and inspections) may ultimately lead to deleterious health effects. This is evident in the number of food-borne illness outbreaks and associated deaths. Negative economic consequences also result through lost wages and productivity, and health care costs. The impact can be far greater in developing nations. Therefore, refining domestic and international food safety policies is at the forefront of many government agenciesā efforts toward protecting the public health. Reducing the number of such incidences has become a priority for government regulatory agencies and the food industry…