Introducing an Innovative, Advanced Aseptic Filling Technology to a New Manufacturing Facility Dr. Aidan Harrington DPS Engineering Agenda • Introducing New Manufacturing Technologies – Perceived Barriers to Entry • Current State of Advanced Aseptic Processing • Our Business Case and Progress to Date Barriers to “Large corporations welcome Innovation innovation and individualism in the same way the dinosaurs welcomed large meteors.” Scott Adams - Dilbert ‘Despite increasing recalls, Current State? contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes’ W. Nicholson Price II, Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing 55 B.C.L. Rev. 491 (2014), http://lawdigitalcommons.bc.edu/bclr/vol55/iss2/5 ‘Desired State: A maximally Desired State efficient, agile, flexible pharmaceutical sector that reliably produces drug products without extensive regulatory oversight’ Ashley Boam, FDA Acting Director Office of Policy for Pharmaceutical Quality – FDA/PDA Joint Regulatory Conference, Sept 2015. Barriers to Innovation Innate Conservatism Reluctant or Lack of Process Understanding Frustrated If it’s not broken….no issues from last audit Innovators? Perceived Regulatory Hurdles Regulatory Support FDA Draft Guidance Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, Dec. for Industry 2015 Advanced ‘An Advanced Aseptic Process is one in Aseptic which direct intervention with open Processing product containers or exposed product contact surfaces by operators wearing conventional cleanroom garments is not required and never permitted’ Akers, J, Agalloco, J, Madsen, R. What is Advanced Aseptic Processing? Pharm. Manuf. 2006: 4(2) 25 – 27. What are we seeing? Isolators…. Isolators…. Isolators • Isolator technology is almost exclusively the pathway • RABS becoming limited to debagging and capping operations • Enhanced sterility assurance thanks to aseptic transfer systems and use of single-use technologies Market Projections Availability of New Technologies