Sterile Nano-suspension Manufacturing

Ascendia is the only U.S.-based CDMO, who owns the NETZSCH Group Vakumix solution for aseptic wet milling process. It allows us to address the complex aseptic manufacturing for nano-suspensions and micron suspension formulations. Our aseptic suspension manufacturing process includes in-line Rotor-Stator homogenization and wet medium milling that results in sterile, high drug concentration, stable suspension for use in long acting injectables, intravitreal, IV, topical, and IM administration.

LNP Manufacturing

Ascendia has integrated Precision Nanosystems’ NanoAssemblr® GMP System into its LNP manufacturing process. Drug development timelines are expedited via a seamless scale-up process to minimize engineering batches and de-risk manufacturing under cGMP conditions for robust and reproducible results.

Your ‘Go-To’ CDMO Partner

Ascendia is your CDMO for pilot spray drying in different environments. Our expertise, including transitioning formulations from non-cGMP to cGMP environments at small or pilot scale, allows for a seamless transition to pharmaceutical companies for larger scale production.

Comprehensive Manufacturing Services

Ascendia manufacturing services are available to pharma and biopharma companies that seek a CDMO as their formulation transfers from a preclinical to Phase 3 and commercial supply. Ascendia can transition quickly to cGMP manufacture of first-in-man clinical materials.