Sterile Injectables Process Development

Sterile Injectables Process Development

Our Process Development services are designed to seamlessly scale your drug product from concept to commercial supply, ensuring every phase aligns with your end goals. With decades of expertise in handling highly viscous formulations, such as sodium hyaluronate exceeding 100,000 cP, we specialize in overcoming challenges related to formulation, sterile filtration, and aseptic filling. Guided by a Quality by Design (QbD) approach based on ICH Q8 guidelines, we identify and evaluate Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), developing cGMP-compliant processes tailored to meet your specific objectives. Our dedicated project teams ensure continuity and collaboration throughout the entire development lifecycle, including formulation, clinical trials, and commercial manufacturing. Whether working with hydrogels, microparticles, small molecules, mAb fragments, proteins, or other advanced materials, we provide flexible solutions and utilize industry-leading equipment to help our partners deliver innovative, high-quality parenteral drug products to market effectively and reliably.