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The pandemic of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has significantly impacted the lives of the global human population…
Bioassays have been an area of contention and discussion for decades. The understanding of the relationship between potency, biological activity and mechanism of action always seems to lead to dialogue with regulators, even today…
Engineered cellular therapy products are among the more complex of immunotherapeutic modalities because they are living drugs. Cell-based potency assays are essential to demonstrate that drug product activity is linked to biological critical quality attributes…
Viral pathogens can cause wide-spread pandemics (influenza type A, SARS-CoV-2), may have high mortality rates (Ebola virus) and pose enormous health and socioeconomic risks. Certain viruses can also be used as agents for bioterrorism…