Ascendia Pharma Announces New Contract Manufacturing Capability to Deliver cGMP Phase I Clinical Trial Materials
Ascendia now offers cGMP manufacturing capabilities for both oral and parenteral dosage forms to support your Phase I clinical trials. We have recently finished the qualification of cleanrooms suitable for manufacture of solid oral dosage forms and injectable drugs (via terminal sterilization by autoclave or aseptic filtration).
Ascendia’s business is providing rapid, comprehensive, and cost-effective contract R&D services for preclinical and clinical-stage drug compounds. Ascendia’s expertise involves finding the most effective method of formulation for poorly water-soluble molecules – for either oral or parenteral administration. Our capabilities include production of nanoemulsions, amorphous solid dispersions, particle size reduction technologies, and oral controlled release. We provide preformulation testing, formulation approach comparisons, dosage form design, and formulation optimization. And now we can manufacture cGMP clinical trial materials as well.
Our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time required to make critical early-stage formulation decisions. We provide both our formulation development and manufacturing on a fee-for-service basis. If you would like more information regarding our formulation development or our new cGMP manufacturing services, please contact Carl Gonzalez at carl.gonzalez@ascendiapharma.com.
Ascendia is located in central New Jersey with offices and laboratories within the Commercialization Center for Innovative Technologies (CCIT). Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market. Ascendia is a privately held company with a mission to provide customized formulation solutions to salvage difficult compounds and to create advanced medicines to help patients prevail over their disease and enhance their quality of life. For more information, visit www.ascendia.com.
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