Drug development teams at pharmaceutical and biopharma companies have no shortage of options when it comes to finding a CDMO partner. Finding the right one for their needs, however, can be a challenge. For more than a decade, Ascendia Pharmaceutical Solutions has met this challenge, providing state-of-the-art services from pre-formulation through to commercialization.

We consistently make the Impossible Possible through a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services. It allows us to support a variety of dosage forms across all modalities using our proprietary enabling technologies, including nano-emulsions, nanosuspensions, nanoparticles, lipid nanoparticles (LNPs), and amorphous solid dispersion technology platforms.

Ascendia Pharmaceutical Solutions prides ourselves on our commitment to showing clients the “Ascendia Difference”, a key facet of which is our unique ability to provide drug development teams with novel approaches to bring drugs to market more efficiently. We use our four proprietary platform technologies – AmorSol®, EmulSol®, LipidSol™, and NanoSol® - as part of our elegant formulation development using Generally Recognized As Safe (GRAS) materials to exceed client expectations. We work closely with clients from conceptualization to manufacturing, providing personalized solutions and transparency throughout the entire development process.

When evaluating a CDMO for potential partnerships, drug developers must carefully consider a variety of factors to determine what will be the right fit for them. Ascendia has designed our “BEST” philosophy to highlight just how we can go above and beyond for our clients. It is the foundation upon which our reputation is built.

Brilliant Technology: At Ascendia, we’re proficient in a wide array of innovative technologies, including our four patented nanotechnologies, for improving formulations of poorly soluble molecules.

Excellent Service: Tailored formulation strategies, robust analytical support, and frequent communication are just a few of the promises made to our clients.

Superior Quality: Our GMP and cGMP manufacturing facilities provide a “one-stop shop” approach that saves clients time and money through seamless project transitions.

Trust: Our 13 years of experience as a specialty CDMO has left a robust track record of success, with many clients partnering with us time and time again.

By adhering to our BEST approach, we have become a Partner of Choice for many pharma and biopharma companies.

All of Ascendia’s operations, including our headquarters, laboratories, and manufacturing suites, are based in the United States, strategically located in the Bioscience Center in central New Jersey. Our 60,000 square-foot facility has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms, as well as Class 100,000 (ISO 8) manufacturing suites. As such, all formulations are designed to meet stringent FDA regulatory standards, from the beginning, streamlining the drug development process and ensuring a successful final NDA review for new drug products. As an added quality assurance, Ascendia provides cGMP and GMP manufacturing capabilities to produce clinical trial materials for sterile and non-sterile products. We are equipped to handle the potent compounds with OEL bandwidth of 1 to 4.

In addition to our proprietary nanotechnologies for improving molecule solubility, stability, and bioavailability, we are the only CDMO in North America with Netzsch Mill equipment. An industry leader in grinding and dispersion technology for over 150 years, the Netzsch Mill and Ascendia Pharmaceutical Solutions partnership provides additional technologies for increasing the bioavailability of poorly soluble or otherwise challenging drug molecules or NCEs.

A partnership with Ascendia combines industry-leading experience and innovative technologies with a long-standing commitment to quality. Reach out today to learn how our experienced team can help transform your ideas into successful market-ready products.