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Technical Needs Survey Results

NIIMBL initiated a Technical Survey Project to access the interests of the biopharmaceutical manufacturing community in the U.S. on different product types, technical project categories, and some project sub-topics relevant to these project categories.

Surveys were conducted at five Regional Meetings held throughout the U.S., attended by participants from industry, academia, and government and non-profit agencies. Respondents selected their top answer(s) to questions from lists of responses prepared in advance. An on-line version of the same survey was also sent to industry representatives that included the industry attendees at the Regional Meetings. Respondents to the on-line survey could ranks their answers to questions and submit their own answers. This summary presents the results of cumulative responses from approximately 230 total responses. The data obtained from the surveys is available on the NIIMBL website (www.niimbl.org) and summarized below. The results of these surveys are not intended to be statistically meaningful and only reflect the enthusiasm and interests of the participants.

Product type

Respondents were strongly supportive of NIIMBL’s plan to address both existing and emerging biopharmaceutical products, with most respondents interested in proteins/monoclonal antibodies and cell therapies, followed by gene therapies and vaccines.

Project categories

The highest level of interest was in the areas of “process development, intensification and platform development” and “analytical methods/process control”. Project categories on “host cell line development”, “reference standards” and “supply chain management/IT solutions” followed with similar popularity, but at much lower interest levels.

Project sub-topics within the project categories

Process development/intensification/platform development

“Continuous processing and integration” was by far the most popular sub-topic in this category, followed by “novel or optimized unit operations”. There was also some interest in “scale-up and scale-down models” and “high-throughput platforms.”

Analytical methods/process control

“Real-time, in-line methods” were by far the most popular sub-topic within this project type, followed by “predictive models and process control”, “sensor development” and “rapid adventitious agent/sterility testing” with similar, but significantly lower levels of interest.

Host cell line development

The sub-topic with by far the most interest was “increased productivity”, followed by “alternative cell lines or platforms” with a significantly lower interest level. A roughly similar number of respondents had no interest in this project category.

Reference standards/regulatory science

There was significant interest in a number sub-topics starting with “acceptable limits for impurities”, and “reference standards for testing”, followed closely by “cell-based standards.”

Supply chain management/IT solutions

The most popular sub-topics were “increased raw material understanding”, and “shelf-life and stability”, followed by “system for cell & gene therapy tracking.”

These results can form the basis for initial discussions within the NIIMBL Technology Activities Committee (TAC) on help inform topics for technical Project Calls prior to having well-established Technology Roadmaps. We are grateful to all that provided feedback.

Click here to view Technical Needs Survey Results


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