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pharmaHUB Mission

pharmaHUB Mission. Resource for collaboration and sharing: Science and engineering research on innovations in pharmaceutical manufacturing . Information, knowledge, modeling & decision support tools for drug product & process design

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pharmaHUB Mission

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  1. pharmaHUB Mission • Resource for collaboration and sharing: • Science and engineering research on innovations in pharmaceutical manufacturing. • Information, knowledge, modeling & decision support tools for drug product & process design • Educational materials & experiences for education and training of pharmaceutical engineers & scientists. • Sharing of R&D and educational output of national projects • NSF ERC Structured Organic Particulate Systems • National Institute for Pharmaceutical Technology & Education (FDA support)

  2. pharmaHUB background • NSF EVO seed project: Oct 2007-09 $190K • Build prototype based on partnership with HUBzero team • Share with ERC CSOP & NIPTE community • Build community • Develop design & plan for “production” version • NSF CDI Type II grant: Oct 2009-2013 $1.93 M • Implement “production” version with expanded content • Address complete product development cycle • Implement additional Hub functionalities , e.g., work flow

  3. Sample of Available Tools

  4. S Boerrigter, IPPH Unit cells, labels View range Representation Options Wire frame Covalent Corey-Pauling-Koltun Van der Waals Contacts and Interactions Hydrogen bonds Crystal Graph Growth Units View Options Lighting, Perspective, Depth ViewStruct: Visualization of Crystal Structures

  5. Particle adhesion simulation

  6. MOPP equipment schedule & resource utilization

  7. Sample of Available Courses

  8. Online Presentations

  9. Cyber-Enabled Product Development Framework API physical propertiesDosage parametersTarget release profile Drug (API) Formulation design Manufacturing parameters Manufacturing process design Targetvspredicted Design modification logic API releaseprofile prediction Virtual patient population(PBPK, PDPK) Dosage regimenPatient population parameters Targetvspredicted Pharmacokinetic, pharmacodynamic response prediction

  10. Manufacturing Model Library Virtual Patient Population models Plasma Concentration Environment (e.g. GI track) Manufacturing & Population dependent API Release Properties Properties of Dosage Form Environment Attributes: ph concentration, cavity size, flow characteristics, etc Dosage Attributes: API distribution, disintegration, porosity, etc API Release % API Released Product Performance Simulations time Product release depends on dosage attributes imparted by manufacturing steps & physiological environment determined by patient characteristics

  11. pharmaHUB experience • HUBzero technology has been well received as a very flexible framework for both users & contributors • NSF ERC program views HUB technology very favorably: • Important vehicle for making ERC work products accessible broadly ( K-12, university, industry & FDA) • Workshop advertised across ERC programs • Growing functional capabilities will enhance future value • Workflow management & workflow templates • Data management of successive utilizations of tools • Management of large numbers of repetitive runs ( Markov Chain Monte Carlo) • Enhanced visualization capabilities K. Kuriyan, , A.C. Catlin and G.V. Reklaitis, “pharmaHUB: Building a Virtual Organization for Pharmaceutical Engineering and Science”, J Pharmaceutical Innovation 4, No.2, 81-89, 2009

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