cGMP Clinical Manufacturing

Whether your product is developed at Particle Sciences or developed elsewhere, we are an excellent choice as your clinical manufacturing partner. To support this, we provide full in-house cGMP analytical services, bioanalytical services and particle characterization at our facilities, along with ICH compliant stability chambers. As a leader in formulation, we have clinical trial material manufacturing capabilities for all of our technologies, including sterile nano-milling, hot melt extrusion (HME), LyoCells®, combination drug/device products, semi-solids, spray drying, films, nanoparticles and a wide variety of additional techniques.

Having cGMP manufacturing adjacent to the formulation and analytic groups means that there is an efficient path from the bench to scale up. In fact, our formulators are directly involved in early stage production. This streamlined system, combined with full in-house analytic support, insures that production proceeds as smoothly as possible whether for a small toxicology study or a full-blown clinical trial.

With over 5,000 sq.ft. of clean room space, we can handle your requirements for clinical trial material supplies. We have Class 10,000 (ISO 7) through Class 100 (ISO 5) clean rooms with laminar flow hoods for sterile drug manufacturing. In addition, for highly potent compounds, we have two dedicated single pass double HEPA-filtered suites.

We routinely support cGLP toxicology batch production, scale up and cGMP manufacture of clinical trial supplies for studies in the US and world-wide. Particle Sciences is your one-stop solution for drug product development needs - getting you from discovery to the clinic as fast as possible while minimizing development-based risk.