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 ...
In a study posted to the bioRxiv* pre-print server, a team of researchers conducted a structure-activity relationship study of boceprevir-based molecules to find antiviral drug candidates targeting ...
SAN CARLOS, BioCardia®, Inc., a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of United States Patent No. 9,945,854 ...
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 ...
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.
The results of research by scientists at the University of California, San Francisco (UCSF), and Arc Institute may point to new strategies for overcoming a fundamental challenge in drug development, ...
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 ...
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