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Pharmaceutical Quality Control

  • June 19, 2024

    Recombinant Factor C Methods for Endotoxin Testing: Towards Sustainable Development and Reliable Supply Chain

    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).
  • March 26, 2024

    Precision matters: Navigating the landscape of quality control in biologics

    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.
  • January 17, 2024

    Addressing Challenges in Expanding Access to Cell & Gene Therapies

    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.
  • January 03, 2024

    Collaborative Research and Quality Control Supports Cell & Gene Therapy Development & Manufacturing

    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.
  • December 20, 2023

    Evolution of Cell and Gene Therapies and the Role of Rapid Quality Control Solutions to Ensure Safe and Effective Products

    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.