Clinical Manufacturing
BioDuro-Sundia’s Irvine facility offers state-of-the-art clinical manufacturing capabilities, uniquely situated on the same campus as our
commercial manufacturing site. This integrated approach ensures seamless transitions from early-phase development to large-scale production. Our phase-appropriate manufacturing includes a wide range of oral formulations such as tablets, capsules, and powder/API in bottles or capsules, all tailored to meet the specific needs of each project. We also specialize in
bioavailability enhancement manufacturing through advanced techniques like spray-dried dispersions (SDD) and hot melt extrusion (HME), utilizing cutting-edge equipment that supports optimal solubility and bioavailability profiles.
Equipped with scalable machinery, our facility is designed to efficiently accommodate all stages of clinical manufacturing, allowing for flexibility as projects evolve. Our experienced operators, guided by expert formulation scientists, ensure a smooth scale-up process and adherence to GMP standards.
Quality is at the core of everything we do at BioDuro-Sundia. Our commitment to excellence is backed by robust quality systems and dedicated QA oversight, ensuring that all products meet the highest industry standards. Each project is managed by a personal project manager who provides constant communication and regular updates, fostering a collaborative environment between our team and the project. This partnership approach enables us to address any challenges proactively and ensure that project timelines are met without compromising quality.
At BioDuro-Sundia, we pride ourselves on a fast and flexible manufacturing approach. We work closely with projects to address timeline constraints and overcome technical challenges collaboratively, ensuring that progress is made efficiently and effectively. Trust BioDuro-Sundia to deliver high-quality clinical manufacturing solutions that accelerate your path to success.
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