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Through a comprehensive technology transfer process, we deliver a successful scale-up model to ensure robust and consistent manufacturing process from clinical to commercial scale.
We collaborate with your team to de-risk the pathway to commercialization, ensure manufacturability, and deliver a quality medicine to the patient.
Our capabilities include:
Our conjugation processes
We develop the most effective processes for manufacturing at toxicology, clinical, and commercial scale using quality by design (QbD) principles.
Our knowledge of cGMP manufacturing enables us to successfully transfer existing processes into our facilities or develop a new innovative process, when needed, to meet your program needs.
Our processes follow ICH Product Lifecycle guidelines which ensure a robust and well characterized scalable manufacturing process.
Utilizing analytics, we ensure the right product quality attributes for your program.