September 21, 2020
Biopharma faces delays obtaining single-use systems according to a survey that suggests disruption caused by the COVID-19 pandemic and increasing demand will result in shortages.
Single-use bioprocessing technologies now dominate the pre-commercial manufacturing space according to research by Bioplan Associates.
The organization quizzed 130 executives at biopharma firms and contract development and manufacturing organizations (CDMOs) and 150 tech suppliers and found that demand for single-use systems (SUS) has continued to increase in recent years.
According to Bioplan managing partner Eric Langer “Well over 80% of survey respondents reported considerable current use of single-use bioprocessing equipment. Fully 84.3% now report use of single-use bioreactors.”
He suggested SUS technologies are being used for a broader range of activities, adding “around 85% of pre-commercial product manufacturing now involves very substantial single-use systems-based manufacturing.”
Increasing demand for SUS is good for suppliers in the short term.
However, in the longer term, biopharma is concerned technology suppliers may struggle to keep up, particularly given the ongoing impact of the coronavirus pandemic.
Execs questioned by Bioplan ranked a “shortage of SUS and other supply issues” as a major worry with many raising concerns about inability to obtain needed single-use supplies in a timely manner,
Other pointed out that the high volume of SARS-CoV-2 vaccine and COVID-19 therapy R&D going on at the moment is likely to make it harder to obtain technologies for non-pandemic related projects.
According to Langer “Nearly all suppliers and many developers are now prioritizing their orders and activities, pushing pandemic/biodefense-related activities to the front of the line.
“Prioritization combined with expected worsening of ongoing shortages, including high-purity polymers, will result in many facilities having longer wait time for suppliers to fill orders, particularly single-use supplies,” he said.
And smaller CDMOs may find it particularly difficult to source SUS according to Langer.
He explained “Big changes will come in the longer term as the industry does its part in resolving the COVID-19 pandemic. The major response will be an expansion of biopharmaceutical R&D and manufacturing activities worldwide.
“These new activities are displacing other bioprocessing to other facilities. For example, smaller CMOs not involved in pandemic-related work are seeing increased future demand as pandemic/biodefense projects are undertaken by other CMOs.”
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