1. 10/11/2005 1 Overview NSF Engineering Research Center for Structured Organic Composites

2. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 2 2 University-Industry-Government Partnership

3. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 3 3 A Structured Organic Composite

4. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 4 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 5 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 6 6 Development Programs: Test Beds THRUST 1: Fundamental Knowledge on Materials, Synthesis & Functionalization Project P1, P2, P3 Development Program I:Engineered Particulates TB2 TB1 Environment / Marketplace REQUIREMENTS OUTCOMES Development Program II:Microcomposites TB4 TB3 Development Program III:Macrocomposites TB6 TB5 PRODUCTS Manufacturing Control, Synthesis Structuring & Monitoring PRODUCT IDEAS Ideas for New Materials & Applications THRUST 2: Fundamental Knowledge on Composites, Synthesis & Characterization P4, P5, P6 Materials Properties & Synthesis Required Structure Required Functionality THRUST 3: Technology Integration Manufacturing Science P7, P8, P9 Structuring Methods Thrust Areas: Projects CSOC Integrated Research Plan

7. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 7 7 Initial Project Line-up P1 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 P2 P3 P4 P5 P6 P7 P8 P9 Projects focus on basic and enabling research addressing technical gaps and focusing on overcoming technical barriers

8. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 8 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 Wassgren Purdue (Project Leader) Steve Beaudoin Purdue (Inter-particle force models) Maureen Howley NJIT (DEM-continuum modeling) Silvina Tomassone Rutgers (DEM-continuum modeling)

9. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 9 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 Harris Purdue (Project Leader) Piero Armenante NJIT (dissolution) Alberto Cuitiño Rutgers (multiscale modeling) Fernando Muzzio Rutgers (mixing, dissolution)

10. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 10 ERC Matrix Organization of Research Thrust I: Materials Synthesis and Functionalization Thrust II: Composites Synthesis and Characterization Thrust III: Manufacturing Science Granular Micro- composites Macro- composites Engineered particulate ingredients TB 1: Microjet synthesis of micro-& nano- particles TB 4: Wet synthesis of hierarchical microcomposites TB 5: Continuous manufacturing of dry macrocomposites TB 3:Multicomp particles using in-line liquid- liquid dispersion TB 2: Micro- particle synthesis via impinging jet precipitation TB 6: Mini- manufacturing : Controlled Formation of Composites Thrusts, Development programs and Test beds

11. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 13 UGGRADK-12 Rutgers Science Explorer REU POST GRAD Cont Educ. Mod. (Industry) OUTREACH (EXPERIENTIAL) FORMAL EDUCATION Summer Intern. Program REU Summer School EPICS Lab Facilities M.S. Ph. D. HS Modules HS Teacher Training/CEUs Certificates LSAMP / AGEP Minors Education, Outreach, and Diversity Roadmap

14. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 14 Multi-Institutional Leadership Team 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. 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 15 Purdue Team Purdue Team 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 *Core faculty

16. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 16 ERC-SOC Industry and Nonprofit Partners Irvine Exelus

17. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 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. Center for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 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 for Structured Organic Composites (C-SOC) Rutgers – NJIT – Purdue – UPRM 10/11/2005 19 Center Status 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