Protheragen Enhances Drug Development with Integrated Analysis Solutions

Protheragen, an ISO9001-certified supplier of pre-clinical contract research and analytical services, has emphasized its commitment to advancing drug development and quality assurance through specialized drug analysis solutions. The company's integrated offerings address critical needs across the pharmaceutical product lifecycle, from early development to regulatory submission and commercialization. A spokesperson for Protheragen stated that pharmaceutical companies rely on rigorous testing to ensure product safety, efficacy, and compliance, and their integrated solutions are designed to meet these requirements by combining stability studies and impurity testing capabilities to provide end-to-end support that streamlines drug development and strengthens quality assurance.

The company's drug analysis services encompass rigorous chemical-physical and targeted impurity evaluations. Chemical-physical tests cover essential parameters such as relative density, melting point, optical rotation, viscosity, particle size and morphology, dissolution, disintegration, and oxygen/water vapor transmission rates (OTR & WVTR). These analyses ensure optimal drug formulation, compatibility, and bioavailability while providing insights into product performance in real-world conditions. Complementing this, the impurity test service targets a broad range of contaminants—including organic, inorganic, heavy metal, elemental, residual solvent, and genotoxic impurities—mitigating risks from manufacturing byproducts, environmental exposure, and degradation processes to uphold product purity and safety.

Stability testing at Protheragen stands as a cornerstone of its portfolio. This includes accelerated stability studies, which use elevated temperature and humidity to predict degradation pathways and shelf life, and real-time stability studies conducted over the recommended product lifespan to monitor long-term performance. Central to these efforts are forced degradation studies, a critical component of drug development and regulatory compliance. By exposing drug substances and formulations to extreme stressors—including heat (dry and wet), light (per ICH Guide Option 2), humidity, acid/base hydrolysis, and oxidation—Protheragen identifies intrinsic stability characteristics and degradation pathways. Leveraging advanced analytical instruments such as LC-MS, GC-MS, NMR, HPLC, and dynamic light scattering (DLS), the team quantifies degradation levels, validates stability-indicating methods, and delivers data-driven recommendations for formulation optimization to enhance product shelf life and stability.

Protheragen's services are distinguished by a commitment to technical excellence, regulatory compliance, and client-centricity. The company's team of experienced scientists brings deep expertise in pharmaceutical analysis and adherence to international guidelines, including ICH standards, ensuring studies meet the highest quality and regulatory requirements. With cutting-edge analytical technology and customized study designs tailored to each drug candidate's unique needs, Protheragen delivers accurate, reliable results within agreed timelines, enabling clients to make informed decisions promptly. The transparent service process—from initial consultation and project planning to analysis, reporting, and follow-up support—ensures clients remain fully engaged and informed at every stage. More information about their services can be found at https://www.protheragen.com.