Ascendia Pharmaceutical Solutions helps pharmaceutical and biotech companies move from concept to clinic with speed, adaptability, and precision. Built on proprietary nanotechnology platforms, flexible cGMP facilities, and a strong quality-first culture, Ascendia Pharmaceutical Solutions ensures that programs advance on accelerated timelines, accommodate complex formulation needs, and meet compliance standards the first time.
Ascendia Pharmaceutical Solutions advances formulations from preclinical concept to clinic-ready material in as little as six to nine months. This speed is made possible through technical expertise, streamlined cross-functional collaboration, and advanced formulation platforms. By integrating research, analytical, and manufacturing functions, project timelines are compressed without compromising quality, precision or compliance.
The foundation of speed is strengthened by proprietary nanotechnology platforms such as NanoSol, EmulSol, AmorSol, and LipidSol. These technologies enhance solubility and bioavailability, allowing formulation strategies to be identified and optimized in the early stage. With state-of-the-art equipment for nanomilling, lipid nanoparticles, liposomes, and aseptic processing, including lyophilization, Ascendia Pharmaceutical Solutions ensures rapid feasibility assessments and efficient scale-up.
Flexibility is critical in drug development, and Ascendia Pharmaceutical Solutions has built its infrastructure to support projects of diverse scale and complexity. From oral solids and topicals to sterile injectables and ophthalmic formulations, facilities are designed to manage both aseptic and non-aseptic projects in parallel. Dedicated cleanrooms, lyophilization capabilities, and modular suites allow multiple projects to move forward simultaneously, avoiding delays and enabling adaptability across challenging molecule types to meet clients’ expectations and deadlines.
The company’s sterile cGMP facility includes multiple aseptic suites equipped to handle complex biologics and challenging formulations. The ability to quickly allocate resources, initiate kickoff meetings, and adapt to project-specific requirements allows sponsors to begin manufacturing within weeks. This infrastructure ensures that both small-scale and complex nanotechnology-driven projects progress efficiently with all equipment readiness.
Quality is built into every step of development and manufacturing at Ascendia Pharmaceutical Solutions. Rigorous due diligence is applied from engineering batches through cGMP production to set a high standard for compliance and reproducibility. Robust documentation, thorough batch records, and electronic quality management systems reduce errors, increase transparency, and strengthen audit readiness. Frequent internal benchmarking and client audits validate the effectiveness of these processes and reinforce confidence in first-pass success.
The transition from hybrid systems to fully electronic quality and documentation processes minimizes human error and strengthens data integrity. Electronic QMS tools streamline deviation tracking, document control, and audit preparation. This transparency ensures clients have confidence in the integrity of the process, batch records, and the reproducibility of clinical supply.
Ascendia Pharmaceutical Solutions has successfully advanced projects with challenging solubility and stability requirements by combining nanotechnology expertise, flexible facilities, and a commitment to quality. One sterile nanosuspension program was advanced from early development to clinical trial material supply in only three months, enabling oncology patients to access urgently needed medication. In another case, a sponsor’s clinical trial was at risk following setbacks with multiple partners; Ascendia Pharmaceutical Solutions stabilized the formulation and delivered a scale-up batch in just five days, followed by long-term support that sustained the program through a multi-year study. These integrated capabilities continue to help sponsors rescue delayed timelines and achieve successful clinical readiness under accelerated schedules.
Fast, flexible, and first time right is not a slogan, it’s the framework that drives every project at Ascendia Pharmaceutical Solutions. With advanced technology platforms, responsive infrastructure, and a quality-first mindset, the company helps sponsors reach the clinic without compromise.
Schedule a meeting with Ascendia Pharmaceutical Solutions to discuss how your molecule can advance quickly, flexibly, and with first-time success!