Ascendia Pharmaceuticals services

Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. During the pre-formulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The knowledge gained on the API helps to select the right salt or polymorphic form, and supports the design and development of an initial dosage form, both for pre-clinical and clinical use. Ascendia’s pharmaceutical science team characterizes the drug candidate by evaluating its solubility profile, physical and chemical stability, and potential salt forms; and identifies impurities and degradation pathways.

Ascendia develops and evaluates a variety of formulations for preclinical non-GLP and GLP studies. We understand the needs of companies with an exciting compound in the discovery pipeline, but with limited amounts of drug substance. We have developed methods for carrying out formulation screening studies with as little as several mg of drug substance. These methodologies can be used to formulate new drugs for initial in vivo experiments when only low milligram quantities of the drug have been synthesized and/or purified.

Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies. At Ascendia, our core business is to develop practical, customized product formulations for poorly water soluble drugs. We offer rapid and cost-effective formulation technology screening services through the utilization of our multiple nano-particle technology platforms.

Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.

Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container.  Successful formulation development can determine drug patentability, lifecycle, and overall market success. With growing pressure to take potential drug candidates from discovery to first-in-man clinical trials on schedule, more pharmaceutical and biotech companies are outsourcing these projects to a contract development and manufacturing organization (CDMO).

Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a key position in the pharmaceutical market by revolutionizing treatments of several serious illnesses. In fact, conditions that were untreatable a few years ago are now being treated via gene-based and cellular biologics.

A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today.  The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product.  A 505(b)(2) new drug application contains full safety and effectiveness reports on the drug product, but allows information required for NDA approval on safety and efficacy of the active ingredient to come from studies not conducted by the applicant. This can result in a much less expensive and much faster route to approval.

Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container.