NIIMBL Publishes Technology Roadmaps For Biopharmaceutical Manufacturing Industry

NIIMBL roadmaps provide pathways to advanced manufacturing capabilities for biopharmaceutical products.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce the publication of three technology roadmaps designed to benefit the biopharmaceutical community. The three roadmaps focus on manufacturing issues involving: (1) Gene Therapy, (2) Vaccines, and (3) Antibody-Drug Conjugates (ADC) and Bi-specific Antibodies.

NIIMBL convened experts from leading biomanufacturers, equipment makers, suppliers, academic institutions, non-profits, and federal agencies. These diverse stakeholders provided a breadth of knowledge and insight into the market drivers, current challenges, and potential solutions to improve the manufacturing capabilities of these biologic products which treat and prevent some of the most debilitating diseases affecting human health. More than 40 organizations, including NIIMBL members and non-members, contributed to the effort.

“Through these roadmaps, we set out to create a clear vision of innovation for biopharmaceutical manufacturing processes and platforms that will, ultimately, enhance access to the medicines that have the ability to improve and save lives. We are grateful to all of those who contributed their time, energy, and talent to this process,” said Kelvin Lee, NIIMBL Institute Director.

The roadmaps address key technology needs and opportunities including process optimization, analytical needs, standards development, and regulatory considerations, among others. Workforce development and training needs are also discussed within the documents.

“The participants in this process took a deep dive into the manufacturing processes and solutions for each of these product types. This effort resulted in a set of comprehensive documents that will benefit the entire biopharmaceutical community,” said Ruben Carbonell, NIIMBL Chief Technology Officer.

The roadmap process was facilitated by the BioPhorum Operations Group. Last year, NIIMBL and BioPhorum announced a partnership to develop NIIMBL roadmaps for the biopharmaceutical manufacturing industry. The NIIMBL roadmaps will form part of BioPhorum’s Biomanufacturing Technology Roadmap and will complement existing industry roadmaps and those in process.

“We are delighted to have facilitated the development and publication of the first three NIIMBL roadmaps. Together with the BioPhorum Biomanufacturing Technology Roadmap, these documents will inform biomanufacturing technology development in the US and worldwide for the next decade and beyond. We look forward to continuing this roadmap collaboration with the NIIMBL community” said Steve Jones, BioPhorum Director

The NIIMBL roadmaps can be downloaded at http://www.niimbl.org.

During a Vision Workshop last fall, stakeholders selected gene therapy, vaccines, and antibody drug conjugates as the first three topics for roadmapping.

NIIMBL will begin work on its next set of roadmaps addressing additional topics of interest to the biopharmaceutical community. Industry stakeholders who are interested in participating in the next phase of roadmapping are invited to join a web-based meeting set to take place on November 14 at 12 pm EST. A face-to-face Vision Workshop will follow in early 2019. The roadmapping process is open to NIIMBL members and non-members. For more information, visit www.niimbl.org.

About NIIMBL
NIIMBL is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA, a network of 14 manufacturing institutes across the country that brings together industry, academia, and the public sector to propel promising research developments, accelerate new products to market, and train tomorrow’s workforce in order to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.

About BioPhorum Operations Group
Since its inception in 2004, the BioPhorum Operations Group (BioPhorum) has become a trusted environment where senior leaders of the biopharma industry come together to openly share and discuss the emerging trends and challenges facing their industry. The strong cross-company relationships built through BioPhorum have provided the solid foundation from which highly effective collaborations have grown, each focusing on key operational challenges, improving competitiveness and reducing patient risk. As well as the Technology Roadmap, BioPhorum runs six other Phorums – Drug Substance, The Development Group, Fill Finish, IT, Supply Partner and Cell & Gene Therapy. For more information, visit www.biophorum.com.