Drug & Device Combination Products

Particle Sciences is the world's leading drug/device combination product development CRO. Whether it's a new chemical entity, a line extension or generic, Particle Sciences is equipped to handle the complete design, formulation and production of our client's drug eluting devices. This includes both highly potent compound and controlled substance based products. We have the industry's only complete design to commercialization solution for hormone eluting devices.

In-house capabilities include extensive modeling, physical characterization, injection molding, high shear mixing, extrusion, co-extrusion and compounding. With our in-house Analytic Services, drug release methods can be both developed and validated. The process starts with our highly refined preformulation approach, DOSE™. DOSE is based on a combination of empirically collected data and propriety computational tools Particle Sciences has built. Combined with Design of Experiments (DoE), a very efficient development process is achieved.

With combination products, polymer control and supply are especially important. Particle Sciences has established preferred relationships with the world's leading polymer suppliers and CMO's thus ensuring a seamless commercialization path for our clients.

Of course, combination product development is supported by Particle Sciences suite of cleanrooms built to handle all projects from sterile manufacturing to those involving highly potent or controlled compounds. Our analytic group takes the project from API characterization through method development and validation, ICH stability programs, into the clinic and through to NDA submission and commercialization. Particle Sciences is the leading source for concept to clinic combination product development.

Partial Equipment List

  • Class 100 through 10,000 Cleanrooms
  • Sterile laminar flow hoods
  • Four twin screw extruders ranging from bench top to 18 mm
  • Strand, film, tube and co-extrusion lines
  • 22-ton injection molder
  • 3-ton bench scale injection molder
  • Wet granulator and high shear mixer
  • Singles screw extruder
  • Induction welders
  • Silverson L4RT-A laboratory homogenizer with M-line capability
  • Buchi Encapsulator B-390
  • Ad-mix Benchmix OPLB-300 Rotosolver
  • Three Ultrasonic 500W dispersers/homogenizers with in-line capability
  • Netzsch Labstar LS1 media mill
  • Two Premier PLM-1.5 liter jacketed double planetary mixer with vacuum
  • Two Buchi B-290 Mini-spray dryers with solvent capability
  • Multiple Sturtevant Qualification Micronizers with sanitary collector capability
  • Roller mills
  • Gaulin 15MR laboratory homogenizer
  • Lyophilizer
  • Semi-automated film and coating
  • Millipore bench-scale tangential flow filtration unit
  • Glass-lined jacketed and pressurized reactor
  • Cooling tower with 2 heat exchangers
  • Haake 9000 twin screw compounding extruder
  • USP water treatment system
  • Multiple Stability Chambers
  • Autoclave
  • M-110EH-30 Basic BioPharma Microfluidizer