A group of global consortia have given new meaning to the term “collaboration” in the pharma industry. Populated by academia and industry, and increasingly governments and regulators, consortia work together to develop and share advanced manufacturing technology.
Douglas B. Hausner, PhD, Associate Director of the Rutgers University/C-SOPS consortium, talked about consortia’s contributions to the development of continuous manufacturing (CM) technology during the opening plenary session at the 2018 ISPE Continuous Manufacturing Workshop, which was held in Arlington, Virginia, 6–7 June.
Consortia are already making a significant contribution to pharma technology, he noted. “Most of this is not about the future—it is about where we are and where we are going,” Hausner said.
Academic consortia are “a sandbox where new tech is incubated with adopters, vendors, regulators, and students.”
All consortia interact and collaborate with industrial sponsors and share information with each other. “It is a community of practice, an attempt to harmonize our approach.” Or, for a more colorful take, Hausner suggested, academic consortia are “a sandbox where new tech is incubated with adopters, vendors, regulators, and students.”
One example of a consortium that helped develop continuous manufacturing solid-dose technology is C-SOPS, a consortium that included participation by early adopters Vertex, Janssen, and Lilly. The C-SOPS team was involved in the Prezista continuous manufacturing process development, the first continuous manufacturing approval for batch to continuous. C-SOPS has also conducted work for the FDA and other major pharmaceutical companies. Other projects are underway.
High visibility for a consortium like C-SOPS is very helpful since it allows the development to be seen, and lets regulators interact and ask questions; this can help to move the technology along more quickly, he noted.
Hausner gave a brief overview of some of the most active consortia:
C-SOPS (Engineering Research Center for Structured Organic Particulate Systems)
Novartis–MIT Center for Continuous Manufacturing
CPAC (Center for Process Analysis & Control)
CMAC Future Manufacturing Research Hub
SSPC (Synthesis and Solid State Pharmaceutical Centre)
RCPE (Research Center Pharmaceutical Engineering)
PSSRC (Pharmaceutical Solid State Research Cluster)
NPTE (New Pharmaceutical Technology and Engineering Institute) http://sinseizai.com/english/index.html
International collaboration is the focus of the consortia model, and consortia are seeing government investment by EU nations and now by the United States (See the sidebar for background on some of the more active consortia.). Academia is working as development partners on emerging technology for manufacturers. As activity has expanded, so has the interaction both directly and indirectly with regulators, Hausner noted.
Look for more interactions among consortia, international collaboration, and dialogue with regulators on advanced manufacturing technology, Hausner predicted. Continuous bio will be the next area of emphasis, and integration of advanced pharma manufacturing with the Internet of Things and Industry 4.0 are coming trends. Consortia are also looking to move to an advanced manufacturing model that could adapt to other advanced manufacturing processes beyond continuous manufacturing.