Ascendia Pharmaceuticals services

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.

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.

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).

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.