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CLASSIZER ONE v0.7 key enabling solutions and TT services based on SPES patented technology for the characterization and design of micro and nanoparticles in biological, industrial and environmental complex fluids Novel Products Based On

  1. CLASSIZER™ ONE v0.7 key enabling solutions and TT services based on SPES patented technology for the characterization and design of micro and nanoparticles in biological, industrial and environmental complex fluids

  2. Novel Products Based On Micro & NanoParticles PH PHARMA RMA CO COSMET SMETICS ICS FOOD AGROC OCHEM HEM particle sizing & characterization for

  3. Traditional Technologies For Particle Analysis Are Based On Light Scatt tter ering ing static light dynamic light single particle nanoparticle coulter scattering scattering scattering tracking analysis counter (mSLS, MALS) (DLS) (sSLS) (NTA) (CC) sensors e.g. . DLS e.g. . SLS sensor LASER ER LASER ER θ data manipulation data manipulation retrieve one parameter retrieve one parameter hydrodyn odynami amic radius us Mie radius us

  4. Traditional Technologies Limits They consider ALL particles as perfect, uniform spheres of the same material Polymer lymeric

  5. Traditional Technologies Limits But particles are NOT T homogeneous, perfect, uniform spheres Polymer lymeric Metalli tallic/Oxi Oxides des Enginee ineered red Ptc tcs Bio co componen ponents

  6. Sing ingle le Partic icle le Ex Extinction inction and nd Sca catte ttering ring (S (SPES) PES) Key Enabling Technology

  7. Single gle Partic icle le Extinc nctio ion & & Scatt tter ering ing (SPES) ES) patented technology for r each ch partic ticle le  tw two indep ependent endent parameter meters • ( capability foreclosed to traditional technologies)

  8. Single gle Partic icle le Extinc nctio ion & & Scatt tter ering ing (SPES) ES) – Published Applications Gold and Silver Drug Delivery Colloid Systems Particles Science Complex Media SPES Key Key-Ena Enabl bling ing Tech ch Emulsions, Liposomes and Microcapsules Environment and Aerosol Abrasives Agrochemicals & and Slurries Pigments Grounded Powders and Inks

  9. Single gle Partic icle le Extinc nctio ion & & Scatt tter ering ing (SPES) ES) – Advantages on biotech/DDS applications Early R&D • High size resolution Log Im S(0) • Structural Studies • Material classification PS Ptc Diameter [nm] Log Re S(0) PS 600nm CeOx PMMA 600nm

  10. Single gle Partic icle le Extinc nctio ion & & Scatt tter ering ing (SPES) ES) – Advantages on biotech/DDS applications Impurities Early R&D • High size resolution • Structural Studies • Material classification Advanced R&D • Directly in complex fluids • No purification/filtration • Monitor aggregation/ degradation/wetting • Esclude microbubble/ immiscible dropplets

  11. Single gle Partic icle le Extinc nctio ion & & Scatt tter ering ing (SPES) ES) – Advantages on biotech/DDS applications Early R&D • High size resolution • Structural Studies • Material classification Advanced R&D • Directly in complex fluids • No purification/filtration • Monitor aggregation/ degradation/wetting • Esclude microbubble/ immiscible dropplets Product QC • On bench (e.g. coupled with autosampler) • On-line / In-line • Production process optimization

  12. CLASSIZER™ ONE v.07 – Single Particle Extinction & Scattering (SPES) patented technology CLASSIZER™ ONE v0.7 based ed on the patent nted ed Sing ngle le Partic icle le Extin inction ction and Scattering ering (SPES) ES) technolo nology gy Polymeric 200nm-20000nm Size measurem remen ent Oxide 100nm-10000nm range nge 1 Gold 75nm-10000nm Size measurem remen ent Dielectric spheres diameter: 10% resolu lutio ion 1 Re Refr fractiv ive e Index ex Dielectric spheres: m = 1.0 - 2.5 range nge 1 Metallic or Complex Particles 1 Refra ract ctiv ive e Index ex Dielectric spheres relative resolu lutio ion 1 refractive index: 10% Numeric eric Partic icle le 10 4 -10 7 particles/mL (typical) Concen entrat ratio ion 1 Fluid d Flow 0.1-100 mL/min (customizable) 1 Sample and sample preparation dependent / preliminary tech values

  13. CLASSIZER™ ONE v.07 – a novel device based on SPES patented technology CLASSIZER™ ONE v0.7

  14. COLLOIDS – Particle Size Distribution, Refractive Index Classification, Numerical Concentration CLASSIZER ™ ONE v0.7 classifies the composition of single particle populations and measure with high resol olution tion the particle size distribution, even for heterogeneous and polydisperse systems Log Im S(0) % ptc / BIN PS Log Re S(0) Particle Diameter [nm] (PS = Polystyrene) Potenza MAC, Sanvito T, Pullia A, J Nanopart Res 17 (2014)

  15. COLLOIDS – Analysis of heterogeneous systems CLASSIZER ™ ONE v0.7 classifies the composition of single particle populations and measure with high resolution the particle size distribution, even for heterogeneou erogeneous and polydisperse systems PS 600nm PS 600nm PMMA 600nm PMMA 600nm Potenza MAC, Sanvito T, Fazio G, KONA Powder and Particle (2015)

  16. ABRASIVES – Particle Size Distribution of polydisperse samples CLASSIZER ™ ONE v0.7 classifies the composition of single particle populations and measure with high resolution the particle size distribution, even for heterogeneous and poly lydisperse disperse systems CeOx Potenza MAC, Sanvito T, Fazio G, KONA Powder and Particle (2015)

  17. SAVE TIME: NO PURIFICATION/FILTRATION/DIALISIS CLASSIZER ™ ONE v0.7 analyses products regardless the presence of synthesis scaps and impurities (e.g. slurry based on AlO 2 , CeO 2 for the CMP of surfaces) CeOx Impurities Potenza MAC, Sanvito T, Pullia A, J Nanopart Res 17 (2015) Potenza MAC, Sanvito T, Fazio G, KONA Powder and Particle (2015)

  18. DRUG DELIVERY SYSTEMS – Drug Loading and product stability CLASSIZER ™ ONE v0.7 is able to discriminate di diff fferen erent inner nner str truct uctures ures for polymeric particles (e.g. Poly(lactic-co-glycolic acid) (PLGA) particles, D50 ~ 400nm) Homogeneou ogeneous Homogeneou ogeneous Core re-shel ell PLGA degrada radation ion via struc ucture ture with drug struc ucture ture struc ucture ture water er inclu lusio ion H 2 O H 2 O H 2 O Potenza MAC, Sanvito T, Argentiere S, Cella C, Paroli B, Lenardi C, Milani P, Scientific Reports 5 (2015)

  19. DRUG DELIVERY SYSTEMS: Measure stability in REAL Biological Media (PLASMA, BLOOD, …) CLASSIZER ™ ONE v0.7 discriminates between particles and murine serum components PLGA Sanvito T, Bigini P, Cavanna MV, Fiordaliso F, Violatto M, Talamini L, Salmona M, Milani P, Potenza MAC, Nanomedicine (2017)

  20. DRUG DELIVERY SYSTEMS: Measure stability in REAL Biological Media (PLASMA, BLOOD, …) CLASSIZER ™ ONE v0.7 detects and monitors particles in medium as as compl complex as as unfiltered unfiltered bl bloo ood or or cell ll ly lysates tes opening novel opportunity for understanding interaction with biocomponent Fi Filt ltered red Murine ne Blo lood Un Unfiltered ered Murine ne Blo lood Sanvito T, Bigini P, Cavanna MV, Fiordaliso F, Violatto M, Talamini L, Salmona M, Milani P, Potenza MAC, Nanomedicine (2017)

  21. IMPROVE PRODUCT STABILITY - Measure sample aggregation CLASSIZER ™ ONE v0.7 recognizes and characterizes aggregates in suspension. Information on aggregate compactness and aggregate size distribution are provided Potenza MAC, Cremonesi L, Delmonte B, Sanvito T, Paroli B, Pullia A, Baccolo G, Maggi V, ACS Earth Space Chem (2017)

  22. NON SPHERICAL PARTICLES – EFFECTIVE MEASUREMENTS Scattering signals of microsized particles strongly depends on their aspect ratio. Traditional technologies consider particles as spheres. Particles misinterpretation typically follows. Quart rtz Kaolinit olinite “Measuring shape and size of micrometric particles from the analysis of the forward scattered field” , J. Appl. Phys. 119 (20 16) “Shape and size constraints on dust optical properties from the Dome C ice core, Antarctica”, Scientific Reports 6 (2016)

  23. NON SPHERICAL PARTICLES – EFFECTIVE MEASUREMENTS CLASSIZER ™ ONE v0.7 accesses to more parameters. Dedicated algorithms can be developed to interpret data. Information on aspect ratio and effective particle size distribution are retrieved. “Measuring shape and size of micrometric particles from the analysis of the forward scattered field” , J. Appl. Phys. 119 (20 16) “Shape and size constraints on dust optical properties from the Dome C ice core, Antarctica”, Scientific Reports 6 (2016)

  24. NON SPHERICAL PARTICLES – EFFECTIVE MEASUREMENTS CLASSIZER ™ ONE v0.7 accesses to more parameters. Dedicated algorithms can be developed to interpret data. Information on aspect ratio and effective particle size distribution are retrieved. “Measuring shape and size of micrometric particles from the analysis of the forward scattered field” , J. Appl. Phys. 119 (20 16) “Shape and size constraints on dust optical properties from the Dome C ice core, Antarctica”, Scientific Reports 6 (2016)

  25. NON SPHERICAL PARTICLES – EFFECTIVE MEASUREMENTS CLASSIZER ™ ONE v0.7 accesses to more parameters. Dedicated algorithms can be developed to interpret data. Information on aspect ratio and effective particle size distribution are retrieved. “Measuring shape and size of micrometric particles from the analysis of the forward scattered field” , J. Appl. Phys. 119 (20 16) “Shape and size constraints on dust optical properties from the Dome C ice core, Antarctica”, Scientific Reports 6 (2016)

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