The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), headquartered in Newark, Delaware, has released three technology “roadmaps” designed to benefit the biopharmaceutical community. These long-range plans focus on manufacturing issues involving: (1) Gene Therapy, (2) Vaccines, and (3) Antibody-Drug Conjugates (ADC) and Bi-specific Antibodies.
NIIMBL brought together experts from leading biomanufacturers, equipment makers, suppliers, academic institutions, nonprofits and federal agencies to shape the plans. 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 NIIMBL roadmaps are available at http://www.niimbl.org.