NIIMBL unveils antibody manufacturing action plan

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) published its 65-page NIIMBL Action Plan for Increasing Flexibility of Antibody Manufacturing for Rapid Response, which is freely available for download on the organization’s website. The guide has assembled insights from industry professionals through interviews and workshops, also sharing the results of a survey that received input from 250 respondents.

NIIMBL is a consortium that unites stakeholders from government, industry, and academia to address industry challenges and collaborate toward finding solutions.

"Over the last year or two, we've seen an increase in conversations around how we can move medical countermeasures to commercial manufacturing as quickly as possible," said NIIMBL institute director Kelvin Lee. "NIIMBL plays a role in facilitating these conversations and developing solutions, including the innovative technologies being demonstrated in our testbeds. For this plan, we wanted to put our heads together and determine what the current state is and what activities we need to pursue. This plan shows what the future of rapid response antibody manufacturing capability could be."

The action plan acknowledges the need for flexibility throughout biomanufacturing in areas such as production, portfolio diversification, and rapid response to emerging health crises, touting collaboration and next-generation technologies as a means to efficiently develop and manufacture therapies.

The plan broadly identifies key challenges in biomanufacturing, detailing each with explanations and proposed solutions, each defined as being a near-, mid-, or long-term goal. These focus points include a lack of mechanisms for sharing information on innovations, lack of industry-relevant standards, lack of infrastructure for demonstration of large-scale technology, insufficient workforce for current and future skill needs, and uncertain business case for innovative technologies.

The plan also discusses oft-used manufacturing platforms and outlines their advantages and disadvantages. The document covers fed-batch manufacturing, intensified fed-batch manufacturing, and continuous manufacturing, which it states can “offer advantages in improved productivity, process flexibility, and facility cost effectiveness.”

But despite its promise, continuous manufacturing currently struggles with lack of adoption, an unclear regulatory pathway, and unproven commercial scalability. Adoption by contract development and manufacturing organizations has been particularly hindered due to the prohibitive costs in investment. According to Kurata et al., which the action plan cites, “Progress to date in implementing continuous manufacturing appears to be slower than anticipated. This is mainly because development and implementation of continuous processes require long period of time to recoup an initial investment.”

A survey asked industry stakeholders to identify the antibody production processes that were most in need of innovation. Respondents cited downstream processing as the greatest area of need, with cell-line development, and upstream processing following closely. Fill-finish and distribution garnered the least attention.