Technology roadmaps specific to vaccines, gene therapies, and antibody drug conjugates (ADCs)/bispecifics are the first of the many impactful industry/government/academia collaborative projects in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) portfolio to reach completion.
Having defined the need for the three roadmapping projects in late 2017, NIIMBL released the final drafts in November, and a second cycle of mappings has now begun.
The three projects were selected to fill gaps in previous roadmapping efforts by the organizations engaged in NIIMBL, including that on biopharmaceutical manufacturing technology developed by the BioPhorum Operations Group (BPOG) in 2017. NIIMBL believes the roadmaps, which each contain specific goals and objectives, will “set the stage for numerous technical and process development efforts in the future.”
All three NIIMBL roadmaps are about 30 pages and follow a similar structure, starting with an analysis of market trends and business drivers as well as references to other roadmaps addressing each relevant topic area. The documents then assess future needs, challenges, and potential solutions, followed by a set of conclusions and recommendations.
Among the needs identified by each of the working groups that are common to all roadmaps are: ● the development and implementation of continuous manufacturing processes where appropriate ● engaging regulators to foster understanding and eventual approval of new products and processes, and ● workforce development to meet the increasing demands of new manufacturing processes.
Additionally, each roadmap goes into substantive detail, with major findings and recommendations for each topic area illustrated by tables and timelines, serving effectively as a strategic plan.
The ADC/biospecifics roadmap addresses molecular design and cell-line development, upstream and downstream supply and process steps, drug product/dosage form related concerns, and analytics. Modeling at all scales of product development – from atomistic studies to process-level understanding – to drive cost-effective manufacturing.
The roadmap for vaccines provides additional specific focus on production facilities and process development for the drug substance and drug product, as well as knowledge management of advanced methodologies and utilization of product/process data and models.
The focus of attention in the gene therapy roadmap is on ● production of cell, plasmid and recombinant viral banks ● plasmid production ● host cell bank production ● viral vector production process ● upstream unit operations, including cell thaw and expansion through transfection ● downstream unit operations extending from harvest through purification ● formulation/stability and fill/finish ● viral analytics, and ● viral vector production facilities needs.
A “vision workshop” is being held at North Carolina State University on January 23, 2019 to advance the NIIMBL effort on additional roadmaps. The public workshop will identify priority topics, and designate team leads and members who will develop the documents during 2019.
[Links to the first three roadmaps and to information on the workshop are provided below.]
NIIMBL’s Mission, Process, and Progress Elucidated at UMass Summit
University of Delaware Professor Kelvin Lee, who is serving as the NIIMBL Institute Director, highlighted the roadmapping efforts in reviewing the institute’s mission, process, and progress at a “Biomanufacturing Summit” coordinated by the University of Massachusetts Lowell in Boston in September.
Lee stressed that technology roadmapping is a key part of the mission of all 14 institutes operating under the “Manufacturing USA Network” – an entity created through the Revitalize American Manufacturing and Innovation (RAMI) Act, signed into law in December 2014.