Biologics

A biosimilar, per FDA, is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product. Compared with a reference product, biosimilars: are made with the same types of...

Let’s start our series Biologics A – Z very appropriately with A for antibodies. Antibodies, or more specifically immunoglobulins based on the sturdy mouse and human immunoglobulins of the IgG subclass, are a major biologics workhorse. They have found wide application...

Respiratory syncytial virus (RSV), human metapneumovirus (HMPV), and human parainfluenza virus types one (HPIV1) and three (HPIV3) can cause severe disease and death in immunocompromised patients, the elderly, and those with underlying lung disease. A protective...

Somatek is attending 2023 BioProcess International US West. The conference takes place from February 27 - March 2 at the San Diego Convention Center under the headline ACCELERATE SPEED TO MARKET FOR YOUR NEXT GENERATION MABS, VACCINES AND CELL/GENE THERAPY PRODUCTS....

This post and a huge thank you to David Sergeant and Justin Foox of Ipratech has been overdue for some time. Early last year, Somatek acquired a CYTOSYS control platform for its process development work. Having experience with bioreactor controllers from several other...

The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, on Wednesday announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen’s investigational HIV vaccine regimen. The...

Much research has gone in recent years into augmenting checkpoint inhibitor immunotherapies to make them effective in more cancer types and for more cancer patients. In this context, there is now excitement about the combination of checkpoint inhibitors with...

About 8 million Americans with diabetes take insulin, a peptide hormone, to regulate their blood sugar. Those without health insurance, or who have high-deductible plans, often spend hundreds of dollars a month on this life-saving medication, and one 2019 study found...

The circadian rhythm influences bodily functions in health and disease. The study of biological cycles driven by environmental and genetic factors is an emerging field and some circadian aspects of metabolism have received considerable attention by the public (looking...

Biologics, especially antibodies, are important cancer therapeutics that have significantly improved outcomes for a number of solid tumors. However, biologics are considerably more costly than small-molecule drugs; in part because they are more complex to manufacture,...