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Phasing out animal testing for new drugs
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...
People are open to testing for Alzheimer’s disease
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...
Trump and biotech, two months in
In an earlier blog post, I collected predictions on what impacts Donald Trump’s second presidential term would have on the biotech and pharmaceutical industries. This is a follow-up to that post, two months into the new administration. (Please note that this post does...
Serratia: in sickness and slime
Recombinant Serratia marcescens nuclease is frequently employed in contemporary downstream processing of viral and protein-based biopharmaceuticals. The enzyme was first isolated from S. marcescens, a bacilliform Gram-negative bacterium that was discovered in 1819. As...
I is for Ionic Strength
Ionic strength is a measure of the concentration of dissociated ions dissolved in a polar solvent; in the context of the life sciences, this almost always means aqueous solutions. The two most common dimensions used to express ionic strength are the same as those used...
H is for Hybridomas and Horseradish Peroxidase
Hybridomas are cell lines historically used in the production of monoclonal antibodies. Mammals such as mice are immunized with an antigen of interest, and their antibody-producing B lymphocytes are harvested. The lymphocytes are fused with immortalized myeloma cells...
How will Trump’s second term affect biotech?
On Monday, Donald J. Trump was inaugurated as the 47th U.S. president, leading many in the biotech and pharmaceutical sectors to speculate on what impacts the second Trump administration will have on their industries. Back in December, an article in Biospace by...
G is for Gene Therapy
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...
First T-cell Engager Has Been Approved
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...
F is for Filtration
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...