Drug development today poses challenges ranging from solubility and bioavailability to stringent timelines and budgets. Pharmaceutical teams have turned to Contract Development and Manufacturing Organizations (CDMOs) to help bring drugs to market quickly to improve care and quality of life for patients. Ascendia Pharmaceutical Solutions has established its Fast, Flexible, and First Time Right philosophy that blends proprietary technologies, expert scientists, and in-house capabilities to meet and exceed those goals with an industry-leading success rate.
Proprietary Formulation Platforms
At the center of this success are four proprietary formulation platforms that have proven to solve problems conventional approaches often struggle to address. Scientific teams deploy or use these platforms to address issues that most often prevent drug advancement, especially solubility, bioavailability, and stability.
Each technology helps drug development teams overcome solubility and bioavailability hurdles to develop novel pharmaceutical products:
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EmulSol®, for production of oil-in-water nano-emulsions, is unique because it uses co-solvents and a good amount of surfactant. It can be for oral and parenteral formulations and can help greatly reduce the irritation and injection site pain for parenterally delivered drugs.
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AmorSol® is used in the production of amorphous solid dispersions. Formulation of a drug substance in amorphous form greatly improves its solubility and dissolution kinetics for “brick dust,” Biopharmaceutics Classification System (BCS) Class II and Class IV products.
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LipidSol® is a lipid nanoparticle (LNP) technology composed of lipid-based assemblies. It was developed to encapsulate small and large molecules, as well as biologics in nanoparticle structures and can deliver genetic payloads intracellularly.
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NanoSol® addresses nano-sized drug particles. Formulation of a drug substance in nano-particle form increases the surface area by 10-20 fold for dissolution, making it ideally suited for intramuscular and subcutaneous administrations. NanoSol can also decrease injection site reactions unrelated to the active pharmaceutical compound.
This breadth enables Ascendia Pharmaceutical Solutions to address diverse formulation barriers within a single integrated framework. Formulation development is faster and flexible approaches are created to overcome drug development challenges.
This advantage is reinforced by the fact that Generally Regarded as Safe (GRAS) materials are used. GRAS minimizes the risk of added time, cost, or regulatory complexity for new chemical entity (NCE) programs.
In-house Team Collaboration
Rather than rely on traditional technology handoffs whereby the formulation team operates in a silo and then washes its hands of the project once it is forwarded to manufacturing, we take a collaborative approach. The operations team is involved early in the process to work with our formulators to decrease tech-transfer risks as a product progresses and expands into robust manufacturing. This philosophy empowers our teams to respond quickly when clients face emergent or unplanned risks.
The approach is easier for Ascendia Pharmaceutical Solutions because formulation development, analytical testing, and manufacturing are all done in our North Brunswick, NJ facility. The teams are literally down the hall from each other, for continual communication as the drug advances from formulation selection into cGMP manufacturing of clinical and commercial materials.
Our 60,000 square-foot facility in the New Jersey Bioscience Center maintains supply chain resilience and offers Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for cGMP manufacture of sterile products, and Class 100,000 (ISO 8) manufacturing suites for production of non-sterile dosage forms. We support batches of up to 5,000 units for vials and pre-filled syringes for early clinical work and up to 30,000 units for vials, prefilled syringes, and cartridge production at larger clinical volumes.
Scientific Expertise
Ascendia Pharmaceutical Solutions typically narrows projects to one or two credible technical approaches rather than pushing clients through broad-based exploratory work to adhere to our Fast, First, and First Time Right mandate. We revisit development selection processes when others leave important gaps in the program strategy. This approach reduces unnecessary experimentation, limits workflow waste, and helps emerging companies avoid losing six months to a year on lower-value activity before reaching the clinic. Our speed-and-focus model is “fast-and-friendly” as evidenced in our ability to start projects in as little as two weeks and provide flexible small-batch support for first-in-man studies. This can only be achieved if it is done by an expert and dedicated team steeped in drug development experience.
Fast, Flexible, and First-time Right Real-world Success
The Fast, Flexible, and First Time Right philosophy has proven invaluable in multiple projects. Here are just two of the many examples:
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Weight Loss Drug - Ascendia Pharmaceutical Solutions has rescued multiple projects, including a top-five pharmaceutical case where we were brought in ten days before the drug supply for a clinical program would run out. This would require the clinical study to start over. Our expert team successfully, scaled-up and produced the product in less than five days. This was after three other CDMOs failed. Thereafter we successfully supported a two-and-a-half-year teratogenic study that led to product approval.
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Oncology Drug - Our team used our amorphous solid dispersion capability to reduce the enormous pill burden of a novel cancer treatment from 40 to 60 capsules per day to four to six. We preserved product – and company – viability with a manageable dosing regimen supporting patient-centricity to improve persistency and compliance.
Your CDMO Partner
Drug development is more complex, as formulations pose greater challenges and demands. Finding a CDMO partner who can do more than solve a technical problem in isolation is necessary to meet target product profiles, daunting timelines, slim budgets, and efficacy goals. Ascendia Pharmaceutical Solutions, through its Fast, Flexible, and First Time Right approach, turns formulation expertise into a scalable, product development path for clinical trials and ultimately regulatory filing.
Contact us today to discuss how we can add value to your project.