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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
Industry experts identify the future focus of the biopharma industry in a new survey.
The National Institute for Bioprocessing Research and Training (NIBRT), an organization that provides training to the bioprocessing industry, released results to its 2016 survey on Jan. 11, 2017. Suppliers, manufacturers, government officials, and people from academia were relatively positive about the direction of the industry, with 69% saying they were “highly optimistic.”
There were 101 respondents in the survey. In some cases, respondents skipped questions, so the percentages are based on the number of respondents for each question (i.e., n is not equal to 101 for all questions). Regardless of this factor, the report provides a broad overview of the state of the biopharma industry and where it may be headed in the next decade.
Newer therapies will be a future focus
Of the products that are currently available, respondents said the the top three most commercially important products are monoclonal antibodies, vaccines, and non-mAb recombinant proteins. In the next 5–10 years, however, vaccines, mAbs, antibody-drug conjugates (ADCs), gene therapies, and cell therapies will be highly important. As a result, respondents expressed concern about establishing cost-effective manufacturing solutions for these newer therapies, and one respondent commented that new devices and the aseptic manufacture of new therapies into new devices will be a priority in the coming years. One respondent added that cell-based therapies and gene therapies will transform the market, but the industry is still 10 years or more from realizing its potential in these fields. Approximately 65% of respondents said that biosimilars will have a major disruptive impact in the biopharma sector during the next five years.
Drug discovery a major concern
Half of the respondents noted that the scientific complexities surrounding drug discovery was the main challenge associated with bringing biopharmaceutical therapies to the market. They were least concerned with submitting products for regulatory approval in the future-approximately 2% of respondents said this was the highest challenge, which is surprising considering the complexities that are associated with demonstrating the safety and efficacy of new products. In light of the recent deaths during trials for experimental chimeric antigen receptor-based (CAR-T) therapies, and the still not finalized draft guidance documents covering stem cell-based therapies, it would seem that manufacturers would be more concerned about regulatory process hurdles for new therapies.
Another top concern among industry veterans is process robustness of manufacturing operations. Fifty-eight percent said this was a concern, and approximately 53% said that reproducibility of a process was a key manufacturing concern.
Other challenges that may affect the growth of the industry included cost considerations of bringing biopharmaceuticals to market and uncertainties surrounding reimbursement of therapeutics. Another noteworthy point that was considered troublesome to the industry was the lack of qualified experts working in biopharma-57% of respondents reported having problems recruiting skilled bioprocess engineers.
Innovation will be necessary
Survey participants said that the area of biopharma could benefit most from innovation was cell-line development and optimization (nearly 67% noted this was a high priority). Additionally, approximately 61% identified bioanalytical capabilities as an area needing improvement, and approximately 59% thought downstream processing could be developed further. The adoption of single-use technologies was identified as having the highest impact on manufacturing (approximately 73% rated this as having the most beneficial impact on biopharma); however, issues with lack of standardization and with extractables and leachables will continue to be technical challenges of single use. Nearly 57% of participants said continuous manufacturing, when fully adopted, would be beneficial to the industry in the next five years-but nearly 64% of respondents also acknowledged that process development of continuous operations was still a major challenge. Half of respondents also said that continuous processing is still considered an “unproven technology” for biopharma and more than half said that regulatory uncertainties, technology transfer issues, and real-time monitoring will continue to prevent full adoption of continuous biomanufacturing.