CLINICAL TRIAL MATERIALS: SUPPLY SERVICES

Bringing drugs to market is more challenging than ever. Shorter timelines. More complex chemistry. Drug development teams need a full-service CDMO partner that can help them bring projects through the pipeline on time and within budget. That’s why so many pharmaceutical companies rely on Ascendia Pharmaceuticals to perform all of the required processes to release material for clinical trial use.

Ascendia does more than solve the most difficult formulations, particularly those for poorly soluble and low bioavailability drugs, using its proprietary nanotechnologies. We provide drug development teams with effective, efficient production of clinical trial materials (CTM) to confirm the efficacy and safety of the drug, during early trial stage.

Our integrated CDMO services, experienced team of scientists, and cGMP facility ensure that we implement efficient and effective CTM processes that allow drugs to seamlessly pass through the pipeline to commercial-scale production. We have extensive experience in many dosage forms, including oral (tablet, capsule, et al), parenteral, topical, and lyophilized delivery. We have a proven track record of meeting deadlines to keep clinical protocols on time and within budget.

Our clinical manufacturing meets the supply needs of Phase I and II pharmaceutical clinical trials. To meet that end, Ascendia CTM services are fully GMP compliant and our team is highly responsive to the individual requirements of each project.

Ascendia meets the FDA guidelines in its CTM processes and maintains chambers to conduct stability testing in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. These measures help assure that the characteristics and performance of the clinical batches will be replicated consistently in commercial batches.

We offer a one-source solution for supplies for early-stage development:

• Analytical Testing
• Cleaning Development and Validation
• Formulation Development
• GMP Batch Manufacturing
• GMP Release Testing with QP Release
• Method Development and Validation
• Raw Material Characterization and Sourcing
• Pilot Batch Manufacturing
• Scale-up

Our CTM services are delivered from our state-of-the-art GMP-compliant facility. It supports investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials.

Proactive Approach

Recognizing time-to-market is essential, our results-driven process development team takes a proactive approach to CTM projects. Our experienced experts meet with project leaders from pharmaceutical and biopharmaceutical companies to gain a full understanding of the process before it reaches manufacturing. This, coupled with our responsiveness, flexibility, and knowledge, allows Ascendia to effectively plan, resource, and execute the most effective programs.

Our innovative modeling and simulation tools have been extremely valuable to reduce the amount of work required for scale-up. It is supported by our technical expertise, as well as low bioburden capabilities, and extensive milling capabilities.

Contact Ascendia today to learn about our integrated product development approach that supports CTM manufacturing, packaging, and logistics services. We can help you overcome the challenges of advancing a drug from formulation development and small-scale GMP manufacturer to first-in-human (FIH) studies.