Strengthening (Bio)Pharmaceutical Supply Chain

The biopharmaceutical manufacturing landscape is undergoing a transformative shift with the widespread adoption of disposable single-use materials, such as disposable bioreactors, bags, tubing, connectors, and filters. These materials are advantageous because they minimize the risks of product cross-contamination, reduce cleaning and validation requirements, and enable flexibility in production, ultimately improving safety, efficiency, and cost-effectiveness in the manufacturing of biopharmaceuticals. But limited availability of disposable materials during periods of increased demand, can seriously affect the supply of biological drugs. To bolster supply chain resilience, the FDA recently released a Guidance for Industry on “Changes to Disposable Manufacturing Materials: Questions and Answers” (U.S. FDA, 2022) . Furthermore, Capgemini’s report emphasizes the necessity for proactive approaches, with only 11 percent of organizations adequately prepared for potential disruptions (Capgemini Research Institute, 2022). This article explores strategies to minimize supplier dependency and ensure a resilient supply chain.

The Risk of Dependency on Single-Use Suppliers

While some of the biomanufacturing processes use disposables only in some of the production steps, others heavily rely on single-use technologies for all the steps, from upstream to downstream. When stainless steel equipment is used, the manufacturers are mostly in control of the production infrastructure. However, there is not the same level of control with the single-use products since they must be delivered by the supplier. Therefore, over the years the biopharmaceutical manufacturers have become highly reliant on the suppliers of single-use components, used for both critical and non-critical production steps, which results in an increased risk. This risk was evident during the COVID-19 pandemic. There was a boost in the production of biopharmaceuticals due to the global COVID-19 vaccination initiatives and, as a result, materials were prioritized for COVID vaccines manufacturing which translated in a global shortage of single-use materials.

Mitigating Dependency Risk through Multi-Sourcing

One way to mitigate supplier dependency risk is by multi-sourcing single use products which consists in using two (or multiple) different suppliers for the same component. Multi-sourcing can improve supply chain resilience by increasing supplier diversification, which reduces the risk of disruptions caused by supplier-specific or region-specific issues, such as regional disease outbreaks or political instability. Multi-sourcing also has its drawbacks, it can lead to an increased complexity in supplier management, higher administrative costs, and maintaining consistent product quality across multiple sources can be more challenging. Despite that, different industries already successfully implement multi-sourcing strategies. For example, in the electronics industry, Apple Inc. is known for sourcing key components of their smartphones from different suppliers. In the aerospace industry, Boeing also works with multiple engine manufacturers to mitigate supply chain risks.

In a real-life use case, Capgemini worked with a biopharmaceutical company to mitigate its dependency on one major single-use materials supplier. Critical single-used materials from alternative suppliers were qualified in order to ensure business continuity. The ultimate goal in multi-sourcing is to be able to use the products from different suppliers interchangeably, without risking the process and patient safety.
The main steps usually required to qualify alternative single-use materials from a different supplier and implement its use in a GMP biomanufacturing process are:

1. Identification of the need: define the need for dual-sourcing, which may be for example due to limited availability of the material, cost reduction or simply supply chain diversification.
2. Supplier selection: evaluate potential alternative suppliers considering aspects such as their quality systems, reliability, regulatory compliance, and material cost.
3. Risk Assessment: identify and assess potential risks associated with the change based on the intended use of the alternative disposable material and the manufacturing process step in which it is used. The regulatory reporting category suitable for the introduction of the alternative must be defined.
4. Material characterization: gather comprehensive data on the alternative materials, including its chemical and physical properties, compatibility with the product and with the process, regulatory compliance and extractables and leachable data, if required. Functional equivalency of the new material must also be demonstrated.
5. Test the prototype: assess a prototype/sample of the alternative material to ensure it fits well within the established GMP manufacturing process steps.
6. Change control: initiate a change control process to document and manage the introduction of the alternative single-use component.
7. Supplier qualification: assess the supplier’s ability to meet quality and regulatory requirements, ensuring materials supplied are safe and reliable for use in biopharmaceutical manufacturing.
8. Material qualification: perform qualification activities to demonstrate the suitability of the alternative material for the specific GMP process in which it will be implemented. Studies to be performed are dependent on the type of material and its intended use.
9. Documentation/systems updates: update all the required documentation and electronic systems to add the alternative material.
10. Regulatory notification and implementation: prepare and submit any necessary notifications or regulatory filings and introduce the alternative single-use material as approved in the change control.

The supply chain of the future is Intelligent

The establishment of intelligent supply chains can further enhance supply chain resilience and optimize multi-sourcing capabilities. By leveraging advanced digital technologies, pharmaceutical companies can improve supplier selection, generate accurate demand forecast and optimize inventories, monitor supplier performance, enhance risk management associated with the supply chain and ensure regulatory compliance across multiple suppliers.
An intelligent supply chain leverages technology to make data-driven decisions and adapt to changing conditions and can help to identify potential risks and vulnerabilities in the supply network. Multi-sourcing provides the flexibility and risk mitigation necessary to ensure a robust and resilient supply chain. Together, they can help organizations to navigate complex supply chain challenges and deliver products reliably to customers while managing risks effectively.

Embrace the path of resilience

It’s time for biopharmaceutical companies to strengthen their supply chains and to embrace the path of resilience. By reducing dependence on a single source, companies can reduce their vulnerability to supply chain disruptions. Building multi-sourcing capabilities has a high positive impact on the supply assurance of the pharmaceutics to the patients, offering an immeasurable value to patient health and well-being while bolstering brand reputation. Act now, for a robust tomorrow.

References:

[1] Capgemini Research Institute. (2022). How greater intelligence could supercharge supply chains. Augmented resilience, performance, and sustainability will allow organizations to take on a customer-centric focus.

[2] U.S. FDA. (2022). Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry.