Lyophilized Formulation Technology Platform

Preformulation Studies

Our pre-formulation studies involve an in-depth analysis of physical, chemical, and biological characteristics of the drug. This phase is critical for identifying potential challenges and designing strategies to address them.

Formulation Development and Optimization

In terms of formulation development, we select suitable excipients, determine the optimal drug-to-excipient ratio, and develop and optimize the lyophilization cycle to ensure efficient freeze-drying (This includes freezing phase, primary and secondary drying phases). Also, we employ design of experiments (DoE) methodologies to optimize the formulation, refining parameters to achieve desired attributes such as stability, potency, and biodistribution.

Clinical Product Manufacturing

Our platform is equipped with capabilities to manufacture clinical-grade products under strict Good Manufacturing Practice (GMP) conditions. We ensure that all products meet regulatory standards and are ready for use in clinical trials.

Scale-up and Commercial Production

Our platform can offer seamless scale-up services to ensure that the transition is smooth and efficient. We also utilize advanced manufacturing technologies and highly controlled processes to produce commercial quantities of lyophilized drugs. Our goal is to maintain consistency and quality throughout the production scale-up, meeting all regulatory requirements and market demands.

From early-stage pre-formulation studies to large-scale commercial production, our platform offers a full spectrum of services under one roof. This integrated approach streamlines the development process, reduces timelines, and cuts down costs.

By understanding that each project is unique, our platform offers customized solutions tailored to meet the specific needs of our clients.

Our teams of highly skilled scientists and engineers have extensive experience in lyophilized and pharmaceutical formulations to accelerate your lyophilized drug development.