Ascendia Pharmaceuticals, one of the fastest-growing contract development and manufacturing organizations (CDMOs), will exhibit at AAPS PharmSci360 in Philadelphia, October 17-20. Pharma and biopharm development teams facing challenges with poorly water-soluble drugs will find the solutions they need in the Ascendia booth (#1201).
A specialty of Ascendia is delivering sophisticated formulations to enhance bioavailability and solubility. Show attendees can meet with Ascendia’s leadership and scientists to learn how the specialty CDMO can be an effective partner. Ascendia tailors its formulation solutions to ensure a rapid and successful transition of compounds from preclinical to the clinic.
Sterile and Non-sterile Enabling Formulations
Ascendia has a proven track record of providing custom sterile and non-sterile enabling formulations. The CDMO also offers analytical methods for new chemical entities, complex dosage forms and 505(B)(2) product development, along with OTCs and nutraceuticals. Key advantages of working with Ascendia include:
♦ Experience in all dosage forms, including parenteral and oral, for small molecules and biologics
♦ cGMP sterile and non-sterile manufacturing capabilities
The success of Ascendia stems from its customer-centric culture that exudes its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust). This unique approach has allowed Ascendia to make the Insoluble Soluble. As a result, Ascendia has been anointed a “Partner of Choice” by clients. Ascendia has helped clients achieve their stated goal within budget and on time, including in instances where others have been unsuccessful.
Formulations for Small Molecules, Biologics
Ascendia delivers sophisticated formulations to enhance bioavailability and solubility using three proprietary nanotechnologies – NanoSol®, EmulSol®, and AmorSol®. Its facility in North Brunswick, NJ maintains stability chambers for conducting non-GMP and cGMP stability studies in accordance with ICH guidelines. Ascendia stability studies:
♦ Determine robustness of formulation prototypes during early development
♦ Ascertain chemical and physical integrity of lead formulations before advancement into animal/toxicology studies
♦ Assure final formulations meet stability for clinical trial
First-in-man Studies
At AAPS PharmSci360, Ascendia will meet with pharma professionals to discuss how the CDMO specializes in early-stage development services for parenteral dosage forms. A major milestone in a pharmaceutical development project is the first-in-man study. This vital achievement is difficult for parenteral products due to the expense of producing clinical trial materials. Ascendia offers fast, flexible, and small-batch size services for conducting first-in-man study efficiently to stay on schedule and within budget.
AAPS Mission
The American Association of Pharmaceutical Scientists (AAPS) provides a dynamic forum for the exchange of knowledge among scientists to enhance their contributions to public health. Its many meetings offer timely scientific programs, on-going education, information resources, networking opportunities, and professional development. At AAPS PharmSci360, attendees can learn more about key industry segments:
♦ Discovery and basic research (DBR)
♦ Preclinical development
♦ Bioanalytics
♦ Clinical pharmacology
♦ Manufacturing and analytical characterization
Contact us to schedule a time to visit our booth.