Defying the shortages in single-use manifold assemblies

Single-use components might not be considered as the most essential parts in biopharmaceutical manufacturing. However, they are quite capable of temporarily paralyzing the entire production of biopharmaceuticals on-site. Procurement bottlenecks of single-use components have intensified the strong demand that even influenced companies to re-consider abandoning the dependency on single-use components.

On the other hand, the pressure on the industry to ensure single-use manifold assemblies availability has amplified as well. However, increasing the quantity is not as simple as it sounds. Materials such as biopharmaceutical grade tubings are manufactured under special standardized procedures to ensure sterility before use.

What are single-use manifolds?

Where to source single-use manifold assemblies?

Angel, working for a CMO that manufactures a non-COVID-19 related vaccine at a commercial level, has felt helpless after he realized that he ran out of options. He uses single use manifolds as sterile consumables to control the fluid transfer for distributing the vaccine after production into single use bags in an automated and sterile manner. The increased batch sizes and the urge to make the filling process more efficient and reproducible has forced him to switch to automated filling.

However, he did not expect the industry to fail in making available single use components for fluid management in an industrialized manner. Standardized assemblies might still be available – with inconsistent lead times though. However, the lead times deteriorate drastically if one deviates from the standard manifold. The lack of customization has jeopardized the biopharmaceutical products that have been produced under surveillance of Angel.