The past few years have revealed the fragility of global drug product supply chains. For pharmaceutical companies, particularly those introducing life-changing injectable drug products to the market, this vulnerability carries significant weight. It is now clear that ensuring uninterrupted access to essential medicines is not just a business imperative, but also a crucial ethical obligation.
As a result, dual-sourcing has emerged as the recognised solution for building resilience. This approach is about strategically partnering with two or more independent manufacturing organisations to secure your commercial supply. Yet, despite the clear advantages of this strategy, many companies hesitate before implementing it, fearing that managing two suppliers could increase their workload.
This blog post aims to show you that, with the right approach and partner, dual-sourcing is strategically advantageous, leading to greater security, compliance and market success.
Streamlining dual-sourcing
Many pharmaceutical decision-makers envision an increase in complexity, duplicating efforts for quality control, audit preparations, extensive documentation and constant coordination across disparate systems. Managing two distinct communication channels and logistical flows can place demands on limited resources, leading to the perception that dual-sourcing is not worth the administrative burden.
However, this perspective overlooks how experienced contract manufacturing organisations (CMOs) have evolved to simplify this process. While the initial due diligence and planning for a dual-sourcing strategy are indeed crucial, the ongoing management doesn’t have to be twice the work. Leading partners have refined their processes to offer streamlined onboarding and tech transfer, acting as a seamless extension of your supply chain team.
This is achieved through dedicated project management teams who serve as your single point of contact, ensuring clear communication channels and robust data exchange protocols. Their extensive expertise lies in harmonising processes and information flow across different manufacturing environments, significantly simplifying your oversight. This collaborative approach ensures a smooth transition and ongoing coordination, mitigating the perceived complexity. While some up-front planning is needed, the initial investment in simplifying supplier oversight pays off – particularly when weighed against the operational inefficiencies, staffing strain, and potential disruptions associated with a poorly integrated dual-sourcing model.
A strategic investment in supply chain resilience and profitability
The cost of qualifying a second supplier, undertaking technology transfer and potentially managing additional inventory at two sites can initially appear prohibitive, leading to the conclusion that sticking with a single source is the more economical choice. This perspective often frames dual-sourcing purely as an expenditure, overlooking its strategic long-term value.
However, it is crucial to reframe dual-sourcing as a wise strategic investment in the future resilience and profitability of your product. Consider the staggering, often hidden costs associated with a supply chain disruption of a critical injectable drug. These far exceed any upfront investment in a secondary partner. These costs include direct financial losses, including lost revenue and market share, exorbitant fees for expedited shipping, substantial penalties for unmet contractual obligations and the economic and reputational fallout of potential recalls if quality is compromised under pressure.
Beyond simply avoiding these costs, having alternative suppliers can provide inherent negotiating leverage, promoting more competitive pricing and service levels over the long term. Furthermore, dual-sourcing enables more strategic inventory management: instead of relying on a single, potentially vulnerable buffer stock, inventory can be distributed across two sites. This has the potential of reducing overall holding costs while enhancing supply security. The financial and reputational damage from even a single major supply chain failure can dwarf the costs of proactive risk mitigation, making dual-sourcing a sound economic decision.
Enhancing quality assurance through harmonised dual-sourcing
Maintaining manufacturing quality across sites is of utmost importance, to do this, a well-executed dual-sourcing strategy is essential. Reputable CMOs operate under rigorous quality management systems (QMSs). Having two compliant partners means two robust QMSs are independently overseeing your product, providing an additional layer of scrutiny and verification.
The key to consistency is meticulous harmonisation. This is achieved through comprehensive quality agreements, precise analytical method transfers and the stringent alignment of specifications for every critical quality attribute. Every batch, regardless of its manufacturing origin, must adhere to the same exacting standards, as patient safety and therapeutic efficacy depend on the consistent quality of pharmaceutical products. Any deviation could lead to unpredictable patient outcomes, product recalls and potential damage to a company’s reputation and financial stability.
Additionally, experienced partners leverage their in-house quality control (QC) labs and deep understanding of global regulatory requirements to provide the necessary oversight and analytical capabilities. This ensures that every product released from a qualified dual-source is indistinguishable in quality and efficacy from its counterpart. This collaborative approach to quality control also promotes the sharing of best practices among sites and the client, ultimately driving continuous improvement throughout the entire supply chain. This means that each partner benefits from the insights and innovations of the others, leading to more efficient operations. For example, by sharing data and experiences, sites can collaboratively optimise processes to limit line loss and enhance overall yield, ensuring resources are used more effectively across all manufacturing locations.
Securing your product’s future
Choosing the right strategic approach and a capable partner means the dual-sourcing of your injectable drug products becomes a powerful strategy. It builds inherent resilience into your supply chain, ensures regulatory compliance, and provides the agility needed to meet evolving market demands, enabling therapies to reach patients who rely on them.
Are you ready to explore how a truly resilient supply chain can safeguard your critical injectable drug product?
Download our comprehensive eBook to discover how Symbiosis can be your trusted partner in achieving unparalleled supply chain security: The Strategic Advantage of Dual-Sourcing for Injectable Drug Products
