Internal quality control is an integral process of laboratory testing. A clinical laboratory's coagulation quality control (QC) program is a critical component of its quality assessment program. The ...
Cell and gene therapies require novel quality control methods due to their complex, variable nature and limited shelf life, challenging traditional pharmaceutical testing approaches. Manufacturers ...
Mumbai: Ensuring the safety and efficacy of medicinal commodities is largely dependent on quality control (QC) testing of pharmaceutical and biological products. Regulatory agencies and specialised ...
Microbial quality control testing is fundamental to pharmaceutical product safety, yet traditional approaches demand extensive resources, specialized expertise and considerable time investment.
Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new ...
Advanced Therapy Medicinal Products are revolutionizing treatment for severe diseases, but ensuring their safety before administration remains complex. Traditional Mycoplasma testing methods can delay ...
Microbial testing laboratories often face challenges such as genetic drift, variability in results, and the need for extensive preparation. These issues can lead to inconsistent results and increased ...