The results from BPTC’s bioPULSE survey on vaccine manufacturing highlight industry predictions for new technologies and risks involved in vaccine manufacturing.
The two most prevalent technological advances expected to have the greatest impact on vaccine manufacturing in the next 5 years are flexible manufacturing and novel delivery systems. Respondents indicated that microbial fermentation, followed closely by mammalian cell culture, are the two technologies best suited to develop new or pandemic vaccines. Compared with mammalian cell culture, microbial fermentation has the advantage of relatively short production cycles and low cost. However, several new, highly effective vaccines are being developed using mammalian cell culture to overcome limitations of traditional egg-based production systems. Application of Quality by Design (QbD) and Process Analytical Technologies (PAT) are also rapidly gaining acceptance in all aspects of biomanufacturing, according to a majority (73%) of respondents. Formulation development (44%) and downstream purification (44%) would benefit far greater than upstream processes (12%) from application of QbD according to respondents. (Share your thoughts on QbD in our current bioPULSE survey!)
Nearly half think access to manufacturing capacity is the greatest risk factor in meeting global demand for vaccines. As the patients in emerging markets are able to access these lifesaving medicines more routinely, vaccine use is expected to increase significantly in the coming years. Recognizing the growing need for new vaccines, two-thirds of the survey respondents indicated that they are either currently developing or plan to develop vaccines. The overall vaccine market has seen growth rates of up to 10% in the past few years fueled by wider use of current vaccines and introduction of new vaccine therapies. Compared to the 5% growth for the overall pharmaceutical industry, the vaccine market should continue to be a bright spot.
One third of respondents are planning to increase the use of disposable technologies in order to allow manufacturing facilities to be rapidly and cost effectively established locally in emerging markets. Only small percentages (4%) of companies are out-licensing vaccine products to companies in emerging markets. This low percentage is most likely due to concerns about protection of intellectual property and manufacturing know-how.
To ensure that new vaccines can reach the patients who need them, it is important for global regulatory agencies not to set divergent requirements for the approval of vaccines in their territories, which ultimately could increase the cost and time to commercialize vaccines, or worse, disincentivize manufacturers from marketing their vaccines in certain territories. It is not surprising that the majority, 64%, of survey respondents indicated that governments should fund the research and development of pandemic vaccines. This may be controversial in some circles, but without government support, most not-for-profits could not provide the funding needed to bring a vaccine completely through its development cycle, and for-profit companies have little or no incentive to develop pandemic vaccines if there is not a guaranteed market (i.e., governments).
The objective of all bioPULSETM surveys is to obtain relevant and focused feedback on topics of interest to the biologics manufacturing community. The web-based surveys are quick, short, and rewarding (everyone who participates will be emailed a summary and analysis of the aggregate results), so we hope you will join the growing bioPULSE community and contribute your insight.
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