Particle Sciences is a leading drug product formulation Contract Research Organization. We integrate complete formulation, analytic, bioanalytic and clinical trial material manufacturing under one roof providing our clients with a cost effective and time efficient partner. Each group at Particle Sciences is led and staffed by experienced industry professionals.
Particle Sciences is the leading drug/device combination product development CRO. Whether it's a new chemical entity, a line extension or a generic product, Particle Sciences is equipped to handle the complete design, formulation and production of our client's drug eluting devices. This includes products based on controlled substances and highly potent compounds.
Choosing among the many drug delivery technologies being promoted can be daunting. In reality, there are a limited number of approaches that are commercially viable. At Particle Sciences we have an array of established techniques that span the range of drug delivery needs. We can help you rapidly arrive at the best technology for your API.
Preformulation studies are the foundation of any efficient drug product development effort. Particle Sciences has developed a custom preformulation approach we call DOSE™. Using state-of-the-art instrumentation, DoE and our own computational tools, a firm formulation foundation is established early on saving our clients time and expense.
Particle Sciences has been at the forefront of fine-particle production and nanotechnology since the early 1990s and we provide a wide range of particulate preparation services. Our efforts have resulted in commercial products scaled to as much as half a million kilos per year. Whether it's Particle Sciences' proprietary technology or conventional systems, our staff knows how to apply these techniques to meet your needs.
Being able to bring your product from Concept to Clinic is one of the things that has made Particle Sciences the go-to group for pharmaceutical development. We are FDA registered and DEA licensed for all schedules and have the infrastructure to handle highly potent compounds. With our Class 10,000 (ISO 7) to Class 100 (ISO 5) cleanrooms we will get your product to the clinic on time and on budget.
Particle Sciences' cGLP/cGMP Analytic Services facilities are equipped with a wide range of state-of-the-art instrumentation and experienced technical staff to assist you in method development/validation, characterization, and routine and specialized testing. Our facility offers exceptional capabilities in physical property characterization. We are FDA registered and DEA licensed to work with controlled substances and can handle highly potent compounds. Our staff has extensive industry experience to help you in data interpretation and analysis.
To support your product development from preclinical through clinical testing, Particle Sciences offers detection, identification and quantification of drug compounds and metabolites in biological fluids and tissues using primarily LC/MS/MS. Our integrated approach spans method development and validation through sample analysis, and our expert staff insures high quality data delivered on time and on budget.
Consistency and quality are critical to pharmaceutical product development. API solid state and the physical properties of the formulation will largely dictate stability, bioavailability and ultimately, performance. As API's move further away from small, readily soluble molecules, these issues have increasing importance. In addition to a full array of standard characterization technologies, Particle Sciences has one of the country's most complete physical characterization labs.
Stability testing and a well-designed ICH-compliant stability program are critical elements of a rigorous drug formulation and development plan. Our facility is equipped with monitored state-of-the-art temperature and humidity controlled chambers for accelerated and long-term stability testing.
We provide a complete suite of drug release assays for a variety of dosage forms ranging from simple tablets to drug eluting devices to nanopaticulate-based formulations. From method development to cGLP/cGMP release testing, Particle Sciences has the infrastructure and expertise to meet your needs. We are FDA registered and DEA licensed for all schedules of controlled substances.
For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, Particle Sciences has the solution. Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing.
At Particle Sciences each project is assigned a Project Leader and Project Manager, the main point of contact. Working closely with the client, the project goals, timeline and budget are documented and the Gantt chart is established. Client meetings, each with a written update, are prescheduled ensuring good communication and continuous alignment of objectives. From post-discovery through to clinical development, we are part of your team.