ABSTRACT
Background & Aim: The SARS-CoV-2 (COVID-19) pandemic caused global challenges throughout 2020. Cell and Gene Therapy (CGT) trials were halted initially to allow healthcare workers and supply manufacturers to address the immediate and urgent needs from the pandemic. The initial decrease in cases of the alpha variant led to the re-launch of many of these trials;however, critical supplies required for manufacturing and administration of products have continued to be in short supply or available with prolonged lead times. An initial survey for CGT Critical Supply Challenges was distributed to the field in late October 2021 and open for two weeks to obtain a baseline understanding of the key challenges. This survey was distributed a second time in early 2022 to assess the changes in critical supply chain shortages over the intervening months. Here we report the cumulative results of the two surveys and describe the continued impact of the COVID-19 pandemic on the critical supply chain within the Cell and Gene Therapy field. Methods, Results & Conclusion: Methods. The survey was created using SurveyMonkey®, an online platform, and contained 10 questions aimed to understand key supply shortages in the context of product type and stage of production. The survey was disseminated through CGT society networks, Google Groups (Small Cell Therapy Lab), LinkedIn®, and personal emails. The survey was distributed initially for one week in October 2021 and data was analyzed. The survey (Figure Presented) was distributed a second time in early 2022 and results from the second survey were analyzed separately and compared to the initial results. Results. The initial survey contained 58 responses and 91% of these had experienced a critical supply shortage in the past 18 months. The most common supply category causing the largest impact was transfer supplies, including plastics, tubing, bags and vials (Fig 1). Half of the respondents experienced a backorder of over 6 months (Fig 2);however, 40% of respondents did not have to delay productions (Fig 3). Supply shortages have continued into 2022 and the second distribution of the survey is to assess any changes in types of supplies that are delayed. Conclusion. A majority of survey respondents have dealt with supply chain challenges since the onset of the COVID-19 pandemic. Shortages and long lead times continue to be present throughout early 2022;however, groups have been able to continue productions through a variety of mechanisms. (Figure Presented) (Figure Presented)