Pharmaceutical Quality Control

On July 26, 2024, the United States Pharmacopeia Microbiology Expert Committee voted in favor of adopting new Chapter <86>, which endorses the use of non-animal derived reagents for Endotoxin testing. Chapter <86> provides additional techniques for bacterial endotoxin testing using non-animal derived reagents and information for manufacturers of new and existing biopharmaceuticals on how to incorporate them into their quality testing – in line with the USP’s commitment to expand the use of animal-free methods and materials.

Humans have been using plant and animal derived products (biologics) to treat disease for thousands of years, but the advent of mass production in the 20th century enabled the growth of biologics as a recognized class of medicines. Unlike chemically derived medicines, which combine specific ingredients in an ordered process, biologics are typically very large, complex molecules or mixtures of molecules that are difficult to characterize.

Cell and gene therapies have been undergoing exciting developments recently, including expansion into second line use for existing products. This means that cell and gene therapies are no longer treatments of last resort, and studies are currently underway for front line use.

The landscape of advanced therapy medicinal products (ATMPs) continues to evolve rapidly, revolutionizing modern medicine to help provide additional treatment options for patients with rare diseases, cancers, and autoimmune disorders.

Cell, gene, and tissue-based therapies, also referred to as Advanced Therapy Medicinal Products (ATMPs), present unique opportunities to address some of the most problematic diseases, like cancer autoimmune diseases, cardiac diseases, etc., including those with limited treatment options and genetic disorders such as cystic fibrosis, thalassemia, hemophilia, and sickle cell disease.