ISPE held its second Facilities of the Future conference. The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators. Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.
Most large companies have an internal group working on the idea of Facilities of the Future. The Global Pharmaceutical Manufacturing Leadership Forum (GPMLF), a group of senior pharmaceutical executives, has designated this subject, along with Developing the Workforce of the Future, as two of four key challenges facing industry. Both challenges were addressed by the many speakers during this two-day conference.
Opening plenary speakers included Lawrence Yu, Ph.D., Deputy Director, Office of Pharmaceutical Quality and Leadership, US FDA; Antonio Moreira, Ph.D., Vice Provost for Academic Affairs, University of Maryland Baltimore Campus; Jay Douglass, COO, Advanced Robotics for Manufacturing Institute; Kent Mansfield, President, TruTag Technologies, Inc.
Dr. Yu spoke about the FDA’s initiative “Integrated Facilities Evaluation Inspection Program.” This concept of operations combines chemists, engineers, and pharmacists in a team-based approach to regulatory approval of the facility and marketing application. This is designed to promote consistency, efficiency, and transparency, with improved timelines for decisions and enforcement actions. He described four types of inspections:
- Pre-approval
- Post-approval
- Surveillance
- For cause
Results are communicated as either a “No Action Indicated” letter (clean slate); “Voluntary Action Indicated” (a yellow warning); “Official Action Indicated” (serious).
Dr. Yu also spoke about trends in continuous manufacturing and congratulated ISPE for promoting discussion on this subject. Three drugs have been approved: Vertex, J&J, and Eli Lilly. He also mentioned a trend towards more robust process control strategy. Throughout the conference, the subject of continuous manufacturing was examined in detail, with presentations from J&J, Eli Lilly, CONTINUUS Pharmaceuticals, and the FDA. The FDA has now approved the conversion of a batch process to continuous manufacturing.
Juandria Williams, Ph.D., acting branch chief at the FDA, manages the CDER Emerging Technologies Task Team (CDER-ETT). To gain designation as an emerging technology, firms must submit a 5-page proposal to this group. The primary criteria are (1) novelty from pharmaceutical science; (2) advancement of product quality. The ETT has played a role in the approval of a 3D printed drug product, batch to continuous manufacture, and a breakthrough product manufactured using continuous processing. The FDA has identified continuous manufacturing as a breakthrough technology.
Dr. Moreira spoke about the Workforce of the Future in the opening plenary, as did Dr. Robert Blouin, Provost, University of North Carolina at Chapel Hill in the closing plenary. There will be a global shortage of workers with skills needed to staff our manufacturing facilities. The universities must improve the academic experience to better prepare graduates for the demands of the facilities of the future. Lastly, Quality Executive Partners gave a presentation on the use of virtual reality for training aseptic operators and laboratory personnel.
Many speakers offered new technologies, with other speakers discussing how to approach process control, scale up, real time release, and accelerated approvals. Robots were featured in new approaches to aseptic processing. Representatives from the BioPhorum Technology Working Group discussed their roadmap for the advancement of bioprocessing, and urged listeners to get involved in this group.
The Facilities of the Future conference offered attendees exposure to a wide variety of subjects, all of which tied back to manufacturing life-saving products at lower cost, at higher levels of reliability, and significant advancements in manufacturing product quality. We look forward to the next production of similar content.