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Pharma Services Category of Particle Sciences

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API Development

Analytical Method Development

Analytical Testing Services

Biologic Drugs

Early Clinical / Phase I-IIa

Formulation Development

Lyophilization

Materials

Medical Device

Preformulation & Material Science

Stability Studies

Structural Characterization

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Particle Sciences

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UNITED STATES

Spray Drying

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Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Spray Drying

Emulsions

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Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Emulsion

Nanoparticles Formulation

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Our passion for complex drug product development means that we can handle just about project, including dosage forms like nanoparticles, resorbable microspheres, films/patches, and lipid-based systems.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Liposome / Microsphere / Nanoparticle

Liposomes

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Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Liposome / Microsphere / Nanoparticle

Hot Melt Extrusion

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Particle Sciences uses this approach for both solid oral dosage forms and drug eluting devices. Combined with our DOSE™ system to quickly hone in on the right polymer choice, HME is an excellent path to increased bioavailability.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Overview

High Pressure Homogenization

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At Particle Sciences we use Microfluidics'® homogenizers to accomplish this. We have capabilities that span early development to sterile cGMPclinical supply.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Overview

Suspensions

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Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Suspension

Preformulation

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Starting with DOSE™, our own preformulation system and proceeding through formulation, production for pre-clinical toxicology, scale up and clinical trial material production, Particle Sciences is expert at efficiently getting our clients to commercializable products

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Overview

Nanomilling Under Aseptic Conditions

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Particle Sciences is a leader in nanomilling (wet, dry, and aseptic), microfluidization, and spray drying. We are presently the only for-hire organization that can perform nanomilling under aseptic conditions at a commercial scale using commercially-available or proprietary mills.

Particle Size Reduction

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Particle Sciences has the complete set of milling technologies in-house including jet, ball and high energy milling (Netzsch® and Dyno®-Mill). We can mill highly potent compounds and can also mill aseptically.

Solubilization

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Particle Sciences has developed a proprietary approach to solubilization using a combination of computational tools and empirical data. DOSE has resulted in several clinical products already and is the basis for much of our work.

Encapsulation

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Employed to protect a given API, taste mask or to facilitate targeted delivery, encapsulation is a proven approach that Particle Sciences has been practicing for over 20 years.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Taste Masking

Antibody-Drug Complexes

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Using our proprietary approach, your targeting ligand or therapeutic large molecule is attached to a nanoparticle that is loaded with the API(s).

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: Antibody Drug Conjugate

Drug & Device Combination Products

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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.

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Pharma Service: Drug Product Manufacturing

Category: Medical Device

Sub Category: Overview

Polymer Processing

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Our polymer processing capabilities include hot melt extrusion, co-extrusion, and injection molding. Particle Sciences has also established preferred relationships with the world’s leading polymer suppliers.

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Pharma Service: Packaging

Category: Materials

Sub Category: Polymer

BET Surface Area

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Particle Sciences has various Analytics and Characterization Equipments for analytical services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: BET Surface Area

Lyophilization

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We have a 120 ft2 lyophilizer that builds upon our existing R&D and clinical lyophilization capability (2 R&D and 2 small-scale clinical lyophilizers). Our commercial lyophilizer is supported with both Clean-In-Place and Steam-In-Place capabilities allowing for aseptic processing.

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Pharma Service: Drug Product Manufacturing

Category: Lyophilization

Sub Category: Overview

Solid Solutions

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Used to modify bioavailability, solid solutions are another go-to technology. Particle Sciences offers several systems for preparing solid solutions including Hot Melt Extrusion and spray drying.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Solid State Characterization

HPLC Analysis

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Particle Sciences runs the full gamut of testing including, among others, ELISA, SDS-PAGE, Western blots, image analysis, HPLC, LC, LC-MS, ligand-receptor binding assays, cellular proliferation, cytotoxicity and cellular activation assays.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

Dissolution Testing

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In vitro dissolution testing of oral dosage forms measures the dissolution rate of an amount of drug substance going from the solid state into solution per unit time under standardized conditions.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Dissolution

FTIR / NIR

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Particle Sciences has various Analytics and Characterization Equipments for analytical services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: FTIR / NIR

Mass Spectrometry and LC/MS

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Our LC/MS/MS bioanalytic services include Bioanalytical method development and validation, Nonclinical and cGLP/cGMP clinical sample analysis, Non-GLP discovery support, TK/PK sample analysis, Dried blood spot analysis, 96-well sample processing and analysis

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and LC / MS

Method Development and Validation

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The work in Analytic Services ranges from early method development through and onto validation and clinical and commercial support. With decades of experience, our staff will help you design and successfully execute a phase-appropriate analytical strategy.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Gel Electrophoresis

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Particle Sciences provides bioanalytic serives by using various instrumentation.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Native Gel Electrophoresis

Custom Stability Studies

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Particle Sciences' pharmaceutical stability programs operate under ICH guidelines, supplemented by custom programs that are designed as needed

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Photostability Analysis

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Our services include Development of stability indicating methods, photostability, accelerated and long-term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Photostability

Physical Characterization

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Particle Sciences is the leading particulate and device based drug product physical characterization company. With growing frequency, regulators are requiring tight control over physical parameters such as particle or droplet size, viscoelastic properties and the correlation of these parameters

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Raman Microscopy

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Particle Sciences has various Analytics and Characterization Equipments for analytical services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Raman

Thermogravimetric Analysis

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Particle Sciences has various Analytics and Characterization Equipments for analytical services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: TGA

UV Spectrophotometry

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UV/VIS/Fluorescence Plate Reader

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: UV Spectrophotometry

Pharmacokinetic Services

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Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing. For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, Particle Sciences has the solution.

Biopharmaceutical Analytical Development

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These analytic methods are used to assay the biological products being formulated and to measure the in vitro potency of the final product formulations. Our services include Biopharmaceutical characterization, sizing and stability.

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Pharma Service: Analytical

Category: Biologic Drugs

Sub Category: Biopharmaceuticals

Formulation Development & Process Design

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Since 1991, we have been designing liquid, suspension, powder, solid solution, semisolid formulations and even drug eluting devices. From drug nanoparticles to multiphasic emulsions to solid lipid nanoparticles Particle Sciences has created many new commercialized products.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Overview

Lipid and Carbohydrate Analysis

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The LyoCell technology combines a lipid based approach with nanoparticles. Leveraging the power of reverse cubic phase geometry, the hydrophobic and hydrophilic domains in these nanoparticles are never more than a few nanometers apart giving the particles unique solubilization properties.

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Pharma Service: Analytical

Category: Structural Characterization

Sub Category: Lipid Formulation

Pharma Services Category of Particle Sciences

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