BIOLOGICS
In April, FDA announced plans to phase out the requirement for animal testing in preclinical safety studies and replace them with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro...
BIOLOGICS, NEWS
The Alzheimer’s Association reports that nearly 4 in 5 older Americans would want to know if they had Alzheimer’s disease before having symptoms, or before those symptoms interfered with their activities. They also want treatment, even if it comes with risks, as long...
BIOLOGICS
Gene therapy aims to fix a faulty gene or replace it with a healthy gene to try to cure disease or make the body better able to fight disease. It holds promise as a treatment for a wide range of diseases, including cancer, heart disease, diabetes, and inherited...
BIOLOGICS, NEWS
As widely reported, earlier this week FDA approved the first in a novel class of immuno-oncology drugs called bispecific T-cell engagers for the treatment of small cell carcinoma. Small cell carcinoma, an aggressive type of lung cancer, currently has a few effective...
BIOLOGICS
Bioprocess filtration comprises the use of filtration techniques to purify and separate biological substances during the production of all biologics, proteins, nucleic acids, and viruses. Filtration plays a critical role in ensuring the safety, efficacy, and quality...
