By Fran DeGrazio, senior industry and technical advisor, Drug Delivery Leader
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Having monitored drug delivery industry trends for many years, I am often intrigued by those that seem, at least on the surface, to be “no brainers.” Especially in this age of heightened risk mitigation, a notable current example is the rise of dual sourcing as a strategy for procuring packaging and delivery systems for injectable products.
Of course, there are benefits to moving in this direction. From my perspective, however, instead of making dual sourcing an automatic decision, there should be a greater understanding of single versus dual sourcing so each biopharma product development company can make the right choice.
My aim here is to clarify the associated risks and advantages with respect to choosing one versus the other sourcing approach for diverse pharmaceuticals and biologics and to propose an alternative strategy for evaluation.
The Ascendency Of Dual Sourcing
Single supplier sourcing became popular years ago, largely thanks to W. Edwards Deming's teachings, a key part of which is his Total Quality Management (TQM) philosophy. TQM started gaining traction in the 1980s. From there, it increasingly permeated the pharmaceutical industry through reinforcement of concepts such as the FDA’s Quality Systems approach to Pharma cGMPs and the ICH Q10 guideline on Pharmaceutical Quality Systems. It was Deming’s belief that single sourcing was preferred to develop a long-term, mutually beneficial relationship with the company and its supplier.
In considering any sourcing strategy, it is helpful to first understand that sole sourcing and single sourcing are not identical concepts. Sole sourcing occurs when only one supplier is available for the product that is being procured. By contrast, in single sourcing, multiple options for suppliers are available; however, the procuring company chooses to work with only one of them.
For example, companies looking for suppliers of primary packaging will likely encounter multiple available component suppliers. The scenario is similar when looking for suppliers of injection delivery systems. For any delivery format (e.g., autoinjectors), there may be multiple suppliers although, ultimately, each supplier may be best suited for particular, perhaps even unique, drug product configurations and/or user needs.
In recent years, particularly in response to challenges posed by the Covid-19 pandemic, dual sourcing has been heavily promoted as an alternative to single sourcing. Dual sourcing involves engaging more than one supplier for a product or service and having more than one at the ready with a procurement process and agreement having already been established. This approach is advocated primarily due to its potential to enhance supply chain resilience.
So, how does a company decide which strategy best meets their needs?
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Having monitored drug delivery industry trends for many years, I am often intrigued by those that seem, at least on the surface, to be “no brainers.” Especially in this age of heightened risk mitigation, a notable current example is the rise of dual sourcing as a strategy for procuring 