According to market Research, the international pharmaceutical analytical testing outsourcing market is projected to have strong growth from 2020 to 2027 1. Drivers of the growth include a rise in demand for biopharmaceuticals, biosimilars, and analytical medications, along with an overall requirement for bio/pharma businesses to streamline operations and reduce costs. To find out more about the criticality of stability testing during drug development, possible differences with small versus large molecules, regulatory requirements, and future trends, Pharmaceutical Technology talked with Ramesh Jayadevan, senior manager of analytic development, Reichard; and Karin Knotting, director contract support analytics, Vetter Development Services.
- JayadevanReichard: Stability Testing is among the most significant steps in the development of new drug products. By doing a series of investigations, Stability Testing applications can determine how long a product will maintain the properties and attributes it owned at the time of manufacture. The effect of environmental factors such as light, temperature, and humidity on a formula’s purity, efficiency, and construction is assessed over time to define both its shelf-life and the essential storage conditions. This information is critical for the regulatory approval of a new medication.
- Stability studies are conducted During all stages of drug development. They generally start at the preclinical phase of drug development and continue through Phase I–Phase III clinical trials to support formula development, and also to meet the regulatory requirements for clinical trials. However, the function of the research and regulatory requirements vary depending upon the item type, the stage of the program, as well as the planned markets.
The first phase of stability testing Usually takes the kind of forced-degradation studies. These studies help to identify the perfect formulation from a plethora of different candidates to take forward for additional testing. The purpose of this is to understand that the main degradation products of a molecule and assist analysts in choosing the best methods for additional stability tests, which mimic real life storage in various global regions. Long-term stability studies will then be initiated and validated on both the API and the drug product.In short, the Goal of the stability testing Process is to create data that shows whether any physical, chemical, or microbiological changes influence the efficacy and integrity of a pharmaceutical product. This helps to ensure medications are safe and effective, no matter where on earth they are provided.