Pharmaceutical Quality Control

In 2020, vaccine research received significant attention as researchers were engaged in the race to develop an effective vaccine against SARS-CoV-2 worldwide. More broadly, the entire pharmaceutical industry is experiencing this rapid growth. In this context, supply chain sustainability is crucial. The use of horseshoe crab blood in the quality and safety control process is essential to ensure the safety of injectable and implantable pharmaceutical products. Environmental challenges are key in the debate around the use of traditional Limulus Amebocyte Lysate (LAL) methods in favor of more sustainable methods such as recombinant Factor C (rFC).

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.