The bioprocess industry isn’t immune to supply chain challenges
These pandemic times have stretched global supply chains to their breaking point. And as a result, the bioprocess industry has been attempting to overcome several major hurdles. Chief among them is a shortage in key components like piping, filters, diaphragms and assemblies due – in part – to massive vaccine development and manufacturing initiatives like Operation Warp Speed.
According to James Vogel, founder and director of The BioProcess Institute, this materials shortage could have been fuelled by a rash of proactive panic buying and bulk ordering in a bid to avoid shortages and keep drug production on track. But what the panic buying has ultimately done, Vogel says, is separate bioprocess firms into two basic camps: the haves and the have-nots. In some corners of the industry, supplier orders are way down. In others, there’s no supply to be found. “The proactive folks were better prepared for acquiring most items, but even they still felt the effects of materials shortages,” Vogel explains. “Others who perhaps didn’t have the most mature supply chains were caught off guard and are still catching up.” Bioprocess firms that were left out in the cold supply-wise are now left looking to source other, somewhat-similar products to replace their preferred materials. Vogel, however, is quick to point out that problems can arise when it comes to evaluating these materials for key factors such as extractables and leachables. Not all products are identical and won’t necessarily provide the same performance – especially where ultra-pure processes are involved.
“There is definitely an increased attitude out there of ‘I’ll take what I can get,’ rather than sticking to very specific criteria for materials. Desperation breeds acceptance of risk and compromising your requirements,” says Vogel. “Overall, we have to keep our finger on the pulse and constantly measure and evaluate materials and components. Otherwise, we as an industry run the very serious risk of quality declines in pharmaceutical products.”
Single-use systems’ time to shine?
Where the pandemic age has created challenges for the bioprocess industry, there have also been opportunities. Specifically, with the push towards MRNA vaccine manufacturing and cell therapies, demand for single-use systems (and high-purity polymers) is rapidly rising. Vogel points to increased flexibility, lower capital investments and more streamlined cleaning as three key factors that have pushed single-use systems to the forefront.
“As bioprocessing firms look for new and innovative ways to address issues with their materials supplies – and keep pace with global manufacturing demands – we’ll likely see a dramatic ramp up in single-use production in the near future,” he says.
About James Vogel:
James Vogel is the founder and director of The BioProcess Institute (BPI) that works with suppliers and end-users worldwide to help the pharmaceutical industry manufacture better drugs. Vogel is a recognized subject matter expert in bioprocessing and biotechnology, with more than 36 years of experience. He also serves as an adjunct professor at the University of Rhode Island.