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  1. Overview NSF Engineering Research Center for Structured Organic Composites

  2. University-Industry-Government Partnership

  3. A Structured Organic Composite

  4. C-SOC Vision of Desired State Given active organic substances & administration/delivery requirements, • Development of structured organic composite product • Design of associated process • Manufacturing execution will occur via Model-predictive integrated framework based on fundamental understanding supported by a minimum of key experiments

  5. C-SOC Mission 1: Develop a scientific foundation for the optimal design of structured organic composites. 2: Develop science and engineering methods for designing, scaling, optimizing and controlling relevant manufacturing processes. 3: Establish effective educational and technology transfer vehicles. 4: Establish effective mechanisms for the inclusion and participation of minorities and women at all levels.

  6. OUTCOMES REQUIREMENTS THRUST 3:Technology Integration Manufacturing Science P7, P8, P9 Structuring Methods PRODUCT IDEAS PRODUCTS Required Structure THRUST 2: Fundamental Knowledge on Composites, Synthesis & Characterization P4, P5, P6 Development Program I: Engineered Particulates TB1 TB3 TB5 Development Program II: Microcomposites Manufacturing Control, Synthesis Structuring & Monitoring TB4 TB2 TB6 Development Program III: Macrocomposites Materials Properties & Synthesis Required Functionality THRUST 1:Fundamental Knowledge on Materials, Synthesis & Functionalization Project P1, P2, P3 Ideas for New Materials & Applications CSOC Integrated Research Plan Environment / Marketplace Thrust Areas: Projects Development Programs: Test Beds

  7. Thrust 1: Material Synthesis and Functionalization Functionalized Nanoparticles for Tissue Targeting Functionalized Particles by Nanocoating Mechanical Strength of Small Organic Crystals • Thrust 2: Composites Synthesis and Characterization DEM for Realistic Particle Processing Computations Deagglomeration of Nano- and Micro-agglomerates Multiscale Computational Tools for Dissolution and Disintegration • Thrust 3: Manufacturing Science Synthesis and Design of Integrated Composite Manuf. Processes Real-time Monitoring of Pharmaceutical Manufacturing Processes MPC Control Strategies for Blending Operations P1 P2 P3 P4 P5 P6 P7 P8 P9 Initial Project Line-up • Projects focus on basic and enabling research addressing technical gaps and focusing on overcoming technical barriers

  8. P4: Discrete Element Models for Realistic Particle Processing Computations • Motivation • Need for correlating system behavior to process conditions and powder properties • Need to scale from the particle level to the unit operation level • Mechanistic understanding for coarse grain models necessary for active control • Approach • Large scale 3D simulations of realistic scenarios • Accurate inter-particle interactions Carl WassgrenPurdue(Project Leader) Steve BeaudoinPurdue (Inter-particle force models) Maureen Howley NJIT (DEM-continuum modeling) Silvina TomassoneRutgers (DEM-continuum modeling)

  9. P6: Multiscale Computational Tools for Dissolution and Disintegration • Motivation: • Dissolution and disintegration profiles are key characteristics of any delivery system. • Relation between ingredient properties/processing with dissolution profiles is unpredictable. • Need for methodologies to accurately predict active release. • Approach: • Combine, expand and develop existing multiscale models and simulations techniques (MD, discrete-continuum, FEM). Mike HarrisPurdue(Project Leader) Piero ArmenanteNJIT (dissolution) Alberto CuitiñoRutgers (multiscale modeling) Fernando MuzzioRutgers (mixing, dissolution)

  10. ERC Matrix Organization of Research Thrusts, Development programs and Test beds Engineered particulate ingredients Granular Micro-composites Macro-composites Thrust I: Materials Synthesis and Functionalization TB 1: Microjet synthesis of micro-& nano- particles TB 3:Multicomp particles using in-line liquid- liquid dispersion TB 5: Continuous manufacturing of dry macrocomposites Thrust II: Composites Synthesis and Characterization TB 2: Micro- particle synthesis via impinging jet precipitation TB 4: Wet synthesis of hierarchical microcomposites TB 6: Mini- manufacturing : Controlled Formation of Composites Thrust III: Manufacturing Science

  11. TB 1: Continuous Particle Synthesis & Coating via Ink-Jet Technology Goal: Demonstrate use of micro-jet methods to form uniformly sized particles from solutions/suspensions • Team Leader: Basaran (ChE, Purdue) • Members:Glasser (ChE, Rutgers), Khusid (ME, NJIT) • Mitra (Chem, NJIT), Rinaldi (ChE,UPR)

  12. TB 6: Mini-Manufacturing System: Controlled Formation of Composites Goal: Design & demonstrate compact, dose-on-demand pharmaceutical mini-factory Team Leader: Reklaitis (ChE, Purdue) Members: Basaran (ChE, Purdue) Khusid (ME, NJIT) Li (Chem, Rutgers) Pinal (IPPH, Purdue)Takhistov (FSci,Rutgers)

  13. Education, Outreach, and Diversity Roadmap K-12 UG GRAD POST GRAD LSAMP / AGEP HS Modules M.S. Minors FORMAL EDUCATION HS Teacher Training/CEUs Ph. D. REU Certificates REU Rutgers Science Explorer Summer School Summer Intern. Program Cont Educ. Mod. (Industry) OUTREACH (EXPERIENTIAL) LSAMP / AGEP EPICS Lab Facilities

  14. Director: Fernando Muzzio, ChE Rutgers Deputy Director: Rex Reklaitis, ChE Purdue (Purdue site leader) Material Synthesis & Functionalization Thrust Leader: Raj Dave, ME NJIT (NJIT site leader) Composite Synthesis & Characterization Thrust Leader: Alberto Cuitino (Rutgers site leader), ME Rutgers Manufacturing Science Thrust Leader: Venkat Venkatasubramanian, ChE Purdue. Multi-Institutional Leadership Team • UPR site Leader: Carlos Velazquez, ChE UPRM • Education Director: Henrik Pedersen ChE Rutgers • Outreach and Diversity Director: Holly Crawford, Engineering, Rutgers • Development Program I Coordinator: Piero Armenante, ChE, NJIT • Development Program II Coordinator: Ken Morris, Pharm, Purdue • Development Program III Coordinator: Bo Michniak, Pharm, Rutgers

  15. Ag & Bio Engr Narsimhan Okos* Chemical Engr Agrawal Basaran* Beaudoin* Harris* Pekny Ramkrishna* Reklaitis* Thomson Venkatasubramanian* Won Food Science Nivens Industrial Pharmacy Byrn Carvajal* Morris* Pinal* Taylor* Mechanical Engr Kim (joint with ChE) Sojka Wassgren* Discovery Park Basu Blau Joglekar Purdue Team *Core faculty

  16. Exelus Irvine ERC-SOCIndustry and Nonprofit Partners

  17. Industry Partners • Roles • Participate in decisions on research & education directions • Participate in translating findings into practice • Help develop future work force: students & postdocs • Collaborate in specific bilateral technical projects • Membership levels • Lead Center members • Abbott, GSK, Lilly, PepsiCo, Pfizer, P&G • Regular Center memberships (three levels) • Level 1: Regular members (9 so far) • Level 2: Center-wide technology affiliates (3 so far) • Level 3: Single thrust technology affiliates (2 so far) • Bilateral Projects with industry on specific issues

  18. Annual Budget Estimate • NSF $3 MM • University cost-share $0.6 MM • Industry memberships $1 MM • Industry bilateral projects $2 MM e.g., Lilly commitment • $100K membership • $300K/y projects • Potential for NSF supplements

  19. Center Status C-SOC has passed multiple stage gates • Letter of Intent : Sept 1, 2004 • Preproposal: Nov 8, 2004 • Invitation to submit full proposal March 1, 2005 • Proposal: June 16, 2005 • Industrial partners: 28 committed • Selection for Site Visit: Sept 20, 2005 • Site Visit: Dec 6-7, 2005 • Universities commit to 14 new faculty lines • Univ Puerto Rico commits to $1 million facility cost-share • Reverse Site Visit: Jan 11, 2006 • ERC Panel Positive Recommendation: Jan 18, 2006 • Division Director sign-off: April 13, 2006 • Completion of NSF approval process: mid-May, 2006