Furthermore, the increasing focus on precision medicine and biologics, such as monoclonal antibodies and gene therapies, showcases a shift toward innovative treatment modalities. These APIs are often more complex than traditional small molecules, presenting challenges in manufacturing and regulatory approval processes.
APIs are active substances or mixtures of substances intended to be used in the manufacturing of a pharmaceutical product. These ingredients are responsible for the pharmacological activity of the drug, whether through curing, preventing, or diagnosing diseases. In contrast to excipients—inactive substances that deliver the API—the quality and integrity of the API are paramount in ensuring the overall performance of a drug product.
Beyond energy production, mitochondria are involved in several other critical cellular functions. They are key players in the regulation of metabolic pathways, the maintenance of cellular calcium homeostasis, and the initiation of programmed cell death or apoptosis. Their ability to regulate the balance between energy production and reactive oxygen species (ROS) generation is vital for cellular health. Excessive ROS can lead to oxidative stress, which has been implicated in various diseases, including cancer, neurodegenerative disorders, and aging.