By Tom Ransohoff (transohoffbptccom)
BPTC’s inaugural bioPULSETM survey focused on perceptions and trends in the development of antibody-drug conjugates (ADCs). The responses to three of the survey questions foreshadow significant growth in the ADC field. First, a vast majority of respondents (83%) expect to see a significant increase in the number of ADCs entering the biopharmaceutical pipeline in the coming five years. Second, as many respondents (24%) indicated that their company is not currently developing ADCs but planned to do so in the future as those indicating that their company is already developing ADCs (also 24%). Finally, an overwhelming number of respondents expect this field to be very large (95% selecting either “massive – as big as MAbs” or “important – but not as large as MAbs”) compared to only 5% who felt that ADCs would be limited to niche markets only. Although we recognized ADCs as an important emerging class of biopharmaceutical products, we were honestly surprised at the strength of opinions from respondents related to the potential of this area.
Along with the optimism for growth in the ADC area, the survey indicated some concerns related to remaining CMC development hurdles and the adequate availability of critical outsourcing services to support development and supply of these products. The results of the survey clearly indicated that conjugation technology and linker chemistries were among the greatest CMC development hurdles for these products. Additionally, a number of potential areas likely to experience increasing demand for service providers, such as CMOs with the ability to handle biologic-cytotoxic conjugates, were identified by survey participants. It will be interesting to see how the CMO/CRO world responds to the increasing demand for services to support ADC products.
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). The topic of the second bioPULSE survey, which is currently open and accessible at www.bptc.com/biopulse, focuses on vaccine manufacturing and supply. Your input is encouraged, appreciated and rewarded!