Advanced Pharmaceutical Manufacturing

Transcription

1 Advanced Pharmaceutical Manufacturing Professor Fernando Muzzio Director, ERC-SOPS Department of Chemical and Biochemical Engineering Rutgers University 10/11/2005 1

2 C-SOPS: Broad strokes Focus: pharmaceutical product and process design Team: 40 faculty, 80 students and postdocs, 120 industrial mentors Participants: Rutgers (lead), Purdue, NJIT, Univ. of Puerto Rico 35 member companies (pharmaceuticals, equipment, instrumentation, software, process control) Very close collaboration with FDA (scientific support for regulations, training for reviewers and inspectors) Budget: NSF ($4,000,000/yr) University cash match (~$1,000,000/yr.) Member companies (cash~$1,000,000, in-kind~$500,000/yr.) Associated cash projects (~$4,000,000/yr.)

3 Transforming Pharma Pharma manufacturing Low to medium capital requirements Knowledge intensive Heavily regulated Development model is in transition from vertically integrated/in-house, to distributed/transactional Change drivers Patent expirations Biologicals and biosimilars Continuous manufacturing Personalized/molecular medicine

4 The three pillars Innovation Park Biopharma Cluster - POCC for small companies - Strategic matching of university capabilities and industry needs - Lower development cost - Accelerate product development ERC-SOPS - Advanced Technology Center - Long term research - Focused on new product and process technologies - Convergent technology development model FDA Regulatory Science Center - Agency/Industry/University coalition - FDA regulatory science needs - Personalized medicine - Medical emergencies

5 C-SOPS Convergent Technology Development Model Projects are conducted and managed by teams of academics and industrial members Industrial participants include: End users of technology, Suppliers of technology components, Technology integrators, Commercialization partners End user need (voice of the customer) is established at the very beginning and revalidated throughout project Built-in commercialization mechanism (commercialization partner is identified early and included in the development) Students learn in this environment by Internships in industry Working with industrial scientists in residence Discussing ENGINEERING RESEARCH CENTER with FOR industrial mentors on a monthly basis

6 Main Technology Initiatives Continuous Manufacturing of tablets and capsules (Rutgers lead) Faster development Lower cost Improved quality Thin films containing drug nanoparticles (NJIT lead) Poorly soluble drugs Pediatric and elderly formulations Adjustable dose (for personalized medicine) Microdosing-based manufacturing (Purdue lead) Multidrug therapies Diagnostics Personalized medicine Point of need manufacturing

7 Continuous Manufacturing Case Study 2004 Rutgers forms continuous manufacturing consortium 2006 C-SOPS funded continuous manufacturing consortium becomes TB Proof of concept achieved 2009 NSF Translational Research Funds ($1.8 million) received October 2010 J&J approaches C-SOPS seeking support to develop INSPIRE Feb 2011 J&J funding for C-SOPS (~ $400K) approved Sept 2011 capital funding for INSPIRE ($15 million) approved Jan 2012 C-SOPS in negotiations with 4 other companies

8 Institutional Impact ERC considered top Engineering priority at Rutgers Many targeted hires at all partner institutions New degree programs at all partner institutions Cultural impact: Outcomes driven research is a model now pursued by many other programs, institutes, and centers ERC input is requested in many areas Strategic planning Interactions with Industry Diversity, Education, and Outreach

9 Lessons learned ERCs are natural springboards for development and commercialization of advanced manufacturing technology Translational research funds are mission-critical Technology focus allows for better than 1.5:1 matching and leveraging Students benefit Our 2011 graduating PhD. Class, largest ever, is fully employed, 66% in fortune 500 companies, 33% in academia Successful ERCs are catalysts for change Increase relevance of research Promote collaboration with industry Support ENGINEERING RESEARCH the CENTER FOR mission of federal agencies (such as FDA)