Ascendia Pharmaceuticals - Solutions/Service Company

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Ascendia Pharmaceuticals: Enabling Innovation in Specialty Pharma

Jim Huang, Founder and CEO , Ascendia PharmaceuticalsJim Huang, Founder and CEO
As a fast-growing specialty CDMO leader, Ascendia Pharmaceuticals is committed to helping its clients overcome the challenges associated with developing complex dosage forms, especially those from poorly water-soluble or biological molecules. The company helps pharmaceutical organizations make the insoluble soluble, and help create advanced drugs by providing formulation, analytical, and manufacturing services.

“We are dedicated to the solubility and bioavailability improvement of poorly soluble molecules and difficult-to-formulate compounds,” says Jim Huang, Founder and CEO, Ascendia. To overcome the solubility challenges, Ascendia leverages its state-of-the-art nanotechnologies, including Nanosol®, Amorsol®, and Emulsol®, that offer sophisticated formulation options to create dosage forms suitable for all delivery methods, including oral, parenteral, and topical administration.

Proprietary nanotechnologies are only part of Ascendia’s success story. The company has a customer-centric culture that exudes its BEST philosophy (Brilliant technology, Excellent service, Superior quality, and Trust) that has made Ascendia a “Partner of Choice” for many clients.

Ascendia’s formulation development services include feasibility studies to determine the compatibility of excipients, active ingredients and delivery components, formulation selection, and optimization. Ascendia delivers trial formulations suitable for initial animal and toxicology studies. It conducts pre-formulation testing, formulation approach comparisons, and dosage form design ideal for toxicology and pharmacokinetic studies, pilot ANDA formulations, and Phase I clinical trial materials. The company develops and evaluates a variety of formulations for preclinical non-GLP and GLP studies. They have also developed methodologies for conducting formulation screening studies using as little a drug substance as possible. These methods allow for the formulation of new drugs for initial in vivo studies with milligram quantities of synthesized drug. Ascendia also supports clients in quickly determining the feasibility of multiple technical approaches for formulation.
This helps enhance the probability of formulation success and reduce the time required to make critical earlystage formulation decisions.

Ascendia primarily supports new drug development and biotech companies optimize their drug product formulation prior to initiating expensive clinical development. Recognizing the value of rapid development timelines, the company offers services specifically designed to reach early-stage key milestones in a development program. Clients can accelerate the translation of compounds from discovery to clinical testing using Ascendia’s tailored formulation solutions,.

The company provides statistical experimental design, shortterm and accelerated stability studies, and analytical method development and validation. Leveraging expertise in modeling and simulation, they can predict the animal PK profile and propose an efficient formulation strategy for preclinical studies.
  • We are dedicated to the solubility and bioavailability improvement of poorly soluble molecules and difficult-to-formulate compounds

By selecting and optimizing a suitable formulation, Ascendia helps clients quickly transition a development program to cGMP manufacture of first-in-man clinical materials. Its proprietary 505(B)(2) product development programs enable creation of novel specialty pharmaceutical products that are enhanced versions of existing medicines. In summary, the company helps accelerate the drug development timeline, including moving a compound from the discovery stage into human clinical trial testing.

Continually executing rapid, comprehensive, and costeffective programs for clients, Ascendia has grown dramatically over the years. As a result of their expertise and solution capabilities, the company has solidified its position as a leading pharmaceutical CDMO, named one of the nation’s fastestgrowing private companies for the last two years by Inc. 5000. In fact, Ascendia has doubled its headcount year-over-year and has expanded its facility to 60,000 square feet.

Looking ahead, the company plans to expand its manufacturing capabilities, solutions, and services to continually support its customers. They aim to extend their ability to offer fast, flexible, and small-batch services for first-in-man clinical studies. For instance, Ascendia will offer late-stage and commercial cGMP manufacturing this year to meet its growth expectations, while expanding its services around biologics.
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Top 10 Contract Manufacturing Organizations - 2022

Ascendia Pharmaceuticals

North Brunswick, NJ

Jim Huang, Founder and CEO

Ascendia Pharmaceuticals is a specialty CDMO dedicated to delivering sophisticated formulations of existing drug products and enabling formulations for preclinical- and clinical-stage drug candidates.

Ascendia Pharmaceuticals