Ascendia Pharmaceutical Solutions has invested in talent, technology, and manufacturing space to now offer pharmaceutical and biological drug development teams services that extend from discovery to cGMP manufacturing. With the new capabilities, clients can transition a development program quickly to cGMP manufacture of first-in-man clinical materials.
As part of the expansion, Ascendia is redefining Contract Development and Manufacturing Organization (CDMO) manufacturing capabilities. Ascendia is currently the only CDMO in the United States with specialized equipment to manufacture aseptic sterile suspensions - and more efficient next-generation RNA-LNP development. The Ascendia scientific team is ready to solve the most challenging formulations to develop drugs for oncology, ophthalmology, and other conditions and in any dosage form.
Expanding its manufacturing capability is a natural extension for Ascendia. For more than a decade, Ascendia has been providing drug discovery and formulation development to pharmaceutical and biological companies with much success. As more clients voiced interest in working with Ascendia further down the drug development pipeline, executive leadership made the commitment to meet customers’ requests.
Ascendia expanded its New Jersey Bioscience Center headquarters with a state-of-the-art 60,000 square foot R&D and manufacturing facility with capabilities, including aseptic processing, fill & finish vials, pre-filled syringes and cartridge, and packaging and labeling. The manufacturing services offered by Ascendia will continue to follow the CDMO’s BEST philosophy that has made Ascendia a Partner of Choice with many customers.
Ascendia is setting a higher standard in CDMO manufacturing with its new services. In fact, Ascendia is the only CDMO in the U.S. with the NETZSCH Group Vakumix. The inclusion of the cutting-edge nanomilling system with an in-line homogenizer and 20L/100L tanks distinguishes Ascendia from other CDMOs. This advanced technology enables Ascendia to provide clients with aseptic sterile suspension services, including homogenization, wet milling, clean in place, and steam in place processes.
Adding the NETZSCH nanomilling system is not the only CDMO-leading capability. Ascendia also is the only CDMO in the United States with a full suite of Precision Nanosystems solutions from discovery to scale up and cGMP manufacturing. Ascendia has invested in the NanoAssembler™ Ignite™, NanoAssemblr™ Blaze+™, and NanoAssemblr™ GMP System nanoparticle formulation systems to develop next-generation of RNA-LNP based therapeutics.
The complete suite of NxGen microfluidic mixers from discovery to GMP manufacturing scale by Precision NanoSystems allows Ascendia to provide drug development teams working in cell or gene therapy utilizing the most comprehensive lipid nanoparticle (LNP) manufacturing capability.. Equipped with the three Precision Nanosystems solutions, Ascendia provides a scalable platform to help customers bring life-changing medicines to market efficiently.
The expanded capabilities support Ascendia’s other manufacturing services. Ascendia has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for conducting cGMP manufacture of sterile injectable products, and Class 100,000 (ISO 8) manufacturing suites for production of oral dosage forms. Ascendia maintains stability chambers for conducting both non-GMP and cGMP stability studies in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Comprehensive analytical development services including the QC and microbial testing are provided by Ascendia, as well. It has invested in the advanced analytical instrumentation that measures particle size distribution and provides data on particle shape and morphology. Additionally, it provides information on the degree of agglomeration, all of which directly impacts drug bioavailability.
The ability to monitor and control these parameters may help make a drug effective that otherwise would pass through the body without absorption. This comprehensive information allows the Ascendia scientists to use its expertise to help reduce time and resources, for potential cost savings when developing drugs.
Ascendia invites drug development teams to explore how their expertise can catalyze the journey from pre-formulation to commercialization. By leveraging their advanced manufacturing technologies, sterile clean room suites, and a deep commitment to quality, Ascendia empowers pharmaceutical and biological companies to overcome their most challenging drug development challenges and bring life-changing drugs to market faster.
Contact Ascendia today to embark on a journey of innovation and success in drug development and manufacturing.