November 19, 2021
COVID-19 has changed how drugs and vaccines are made according to experts who say limited raw material supplies and manufacturing capacity have forced industry to innovate in sourcing and inventory management.
The pandemic has disrupted the global supply of consumables and technologies according to Josh Speidel from Latham BioPharm Group, who said on BioProcess Insider’s recent State of the Industry webinar that delivery timelines have increased significantly.
“The pandemic has put immense pressure on the global manufacturing capacity” adding that efforts to develop vaccines resulted in “capacity shortages for vials and single use components piping, filters and bags.”
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“And as a result, the US government made significant investment in novel vial types that were less reliant on boron silicate glass. And they’re also actively leveraging the defense procurement act to place themselves at the front of the lines received the scarce materials.”
“Our clients are seeing across the board delays in the availability of raw materials, equipment pyramid form fitting tube assemblies, container closure materials, and filters. In our experience, the standard lead times to these products is being exceeded by three times. In certain raw materials that are typically six weeks to procure have lead times from three to five months.”
And the shortage of raw materials and consumables further impacted the manufacturing sector Speidel said, citing US contractors as an example.
“I’ve seen multiple cases where filters especially larger filter sizes have 18 to 24 month lead times for the US base CDMO capacity for monoclonal antibody production was significantly constrained with some vendors quoting three years for their first available GMP manufacturing line.”
This lack of manufacturing capacity and raw materials has forced the drug firms and CDMOs Latham BioPharm works with to innovate to Speidel, who said, “So they’re looking at qualifying vendors in India and China places that they wouldn’t normally seek to qualify for raw materials.
“They’re changing their manufacturing processes to accommodate the absence of a particular excipient. They’re changing their filtration methods to allow them to use filters that are available versus filters that are ideal. And many of these changes require redevelopment to their products or we manufacture the product so they can conduct comparability studies, and there are regulatory hurdles associated with the changes that if it weren’t necessary, they would never try.”
For Amelie Boulais, head of market entry strategy at Sartorius, uncertainty was the biggest challenge that resulted from the pandemic.
The pandemic had a huge impact on our sales and explain the entire supply chain for the industry has been stretched by the pandemic. And it’s also starting from our own suppliers. So from our perspective, we already had a robust supply chain, meaning that we try to mitigate any risk of shortages or unanticipated disruptions, we monitor our stock levels during daily operations,
“But all our strategies rely on the forecast from our customers. And with COVID, suddenly some customers stopped working. For example, the gene therapy field, just stopped production because the trials were on hold.”
The sudden increase in demand for vaccine production technologies was also a challenge Boulais said.
“We had all those customers and companies who are trying to develop and starting to develop vaccines with different type of methods – relying on mRNA, relying on recombinant proteins or inactivated vaccines on viral vectors – So we have to anticipate what will be the products that will be order tomorrow for the production. And that’s not that was not an easy an easy thing to do.”
Sartorius’ response was to expand capacity Boulais said, explaining that the firm hired additional staff, extending shifts, operated at higher production capacities and accelerated planned manufacturing facility expansions.
“We have been prioritizing all products requests that were going into vaccines and to COVID-19 applications. We have been trained to really maintain flexibility. And we have been able to provide all the customers that were working on the on the vaccine applications and to find the best solutions. But it has been a tough period and all our forecasts have been completely changed because of COVID.”
Acting quickly was key to ensuring a sufficient supply of raw materials and technologies according to Patrick Lucey, CEO of cell therapy CDMO, Lykan Bioscience.
“We actually have avoided a lot of these delays in the cell therapy space. Obviously, the equipment we use a much amount of materials we use is very reasonably small scale. And so we’re not looking for major demand of excipients or media components or buffer components or disposables.
“So we’ve been able to navigate this in a couple of ways. First, you know, our supply chain team was pretty forward looking. So there are common materials across all biologics manufacturers, cleaning materials, and things like this.
Lucey added, “So we moved quickly, early on, and stockpiled a lot of these cleaning materials and things to be prepared for changeover and all that work. So we have a great stock of those materials.”
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