Ensure Sterility In End-To-End Bulk Management

A global Contract Manufacturing Organization (CMO) with total turnover of approx. 5 billion USD, manufactures various drug substances. Among these are monoclonal antibodies and other highly valuable drug substances for all lifecycle phases – from clinical phases to commercialized products with volumes of up to 800 liters per batch.

In one of its plants, situated in the Netherlands, the bulk drug substance (BDS) is being filled into many smaller single use bags, frozen to -80°C (-112 F), shipped internationally and thawed and drained at the fill-finish site for final drug processing.

The use of single use systems throughout bulk management during filling, freezing, shipping, thawing, and draining with plastic bio-containers, single use bags, tubings and connectors is state-of-the-art in the industry.

The CMO experienced sporadic product loss through cross contamination. To mitigate risks for further losses through contamination, the innovative CMO was looking for a reliable approach to guarantee sterility in their processes from Downstream to Fill & Finish by all means.

Granting a closed system of BDS was key. Therefore, any type of manual handling was explicitly not pursued.

The challenge was to find out how to connect process steps in a closed manner that are most suitable for the CMO that also match the conditions and expectations of the ambitious manufacturer.