The novel coronavirus pandemic has exposed vulnerabilities in biopharmaceutical industry approaches to supply-chain management. Drug developers and manufacturers have tended to presume suppliers’ access to raw materials for bioprocess components. However, global crises disrupt reliable access. Ari Ojinaka (production manager at Astrea Bioseparations) joined BPI in October 2021 to explore strategies for navigating supply-chain uncertainty. He described how his company seeks to optimize manufacturing capacity, enhance communication with its suppliers and customers, and support a quality-driven company culture.

Ojinaka’s Presentation
Traditional supply-chain strategies remain relevant. Biomanufacturers and bioprocess vendors still should qualify at least two suppliers for critical components and use distribution resource planning (DRP) to secure access to different shipping channels. But focusing on supply-chain reliability cannot help companies to mitigate near- and long-term disruptions posed by events such as Brexit and the COVID-19 pandemic. Striving for supply-chain resilience can help to mitigate changing economic conditions.

Resilience depends on two factors. Visibility describes a company’s ability to anticipate disruptions and respond in ways that minimize impacts upon product delivery. Improving supply-chain visibility includes enhancing communication with customers and raw-materials suppliers to hone supply-and-demand planning. Robust data analytics also can help companies to understand previous economic trends and plan accordingly.

Resilience also requires agility. Building capacity redundancy enables suppliers to react quickly to short-term changes, yet operations must be efficient. Thus, suppliers must balance cost of materials against availability of resources that could accommodate demand shifts and minimize impacts from delayed shipments.

Ojinaka demonstrated those considerations by describing his company’s response to a COVID-related supply-chain disruption. Early in 2021, a supplier contacted the Astrea Bioseparations facility on the Isle of Man, UK, about raw-material shipment delays due to lockdown conditions. The supplier could not confirm when delivery would occur. A second supplier faced similar obstacles. That material was required to manufacture a product for a customer in 10 weeks.

Clear and frequent communication with suppliers enabled the Isle of Man team to learn about the problem quickly and develop new plans. Management worked equally closely with customers to notify them about potential delays and supplier changes. Redundant capacity enabled the team to adjust work schedules and accelerate operations to accommodate a new timeline. The site also benefited from having flexible workspaces and previous opportunities for cross-training.

The site’s quick response stemmed in part from its previous implementation of a three-stage quality risk management (QRM) approach to supplier changes. A quality assurance (QA) team vets available suppliers during sourcing and qualification. Material specifications and criticality assessments help the team to determine how much and what kind of work must occur during qualification. Quality-impact review includes risk assessment, an official change-control request (CCR), and evaluation of trial batches. Implementation entails completion of a CCR, addition of a qualified supplier to the Astrea Bioseparations material and audit system, and updates to documentation. Ojinaka highlighted that before the pandemic, his company had notified customers about supplier changes during quality impact review. Now, it provides notification as early as possible to increase transparency and strengthen communication.

Astrea Bioseparations plans to increase its supply-chain resilience. It already has developed internal capabilities for manufacturing affinity ligands, base matrices, and attachment chemistries. The company also has invested in data orchestration systems to preempt supply-chain fluctuations, and it has partnered with customers to establish safety stocks. Agility can be increased by developing new opportunities for retraining employees. As evidenced by a new site in Singapore, the company also is expanding its distribution networks.

Questions and Answers
How much capacity does Astrea Bioseparations set aside? It generally uses 75% of available capacity, which provides enough resources to accommodate additional projects.

How long does it take to identify and qualify a new supplier? That depends on the criticality of a given raw material. A week or two might be enough to evaluate suppliers of noncritical raw materials. Critical materials, however, necessitate extensive testing of trial batches. That process could take 10 weeks.

The recorded webcast is available to view on-demand: Watch Now.