Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...

A new study posted in the preprint server bioRxiv* aimed to analyze the qualitative and quantitative impact of spike (S)-induced humoral immunity along with its antibody-dependent cellular ...

There are unique challenges when it comes to cell therapy products, including ensuring the reproducibility and consistency of product lots. These specific concerns arise from the inherent variability ...

Chimeric Antigen Receptor (CAR) T-cell immunotherapy holds enormous potential for the treatment of cancer. The goal of cell therapy is to not only achieve tumor reduction but also to activate an ...

Researchers from Janssen Pharmaceutica NV have reported the discovery of novel hepatitis B virus (HBV) capsid assembly modulators (CAMs) as potential therapeutic candidates against HBV infection.

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Potency is a critical quality attribute of biological products, defined by the US FDA as the specific ability of the product to cause the required therapeutically clinical benefit. Potency assay will ...