How single use technologies can ensure sterility during bioprocessing

Ben Wylie, senior product manager at ChargePoint Technology explains how single use technologies can help pharmaceutical manufacturers during bioprocessing.

The global single use bioprocessing market was valued at USD 9.71 billion in 2017 and is projected to expand at a CAGR of 13.6% by 2027. A rise in demand for small batch, novel therapies is in turn leading to an increased need for vigorous and flexible containment strategies to ensure product sterility during bioprocessing. Consequently, the technologies used in aseptic processing have seen much innovation in recent years but it’s important for such solutions to also achieve cost reductions, process efficiencies and improved quality in line with industry regulations.

The growth of the bioprocessing market is also fuelling the booming contract services space. Much of the development, manufacturing and packaging of products is completely outsourced. While supporting the development of novel biologics, this can bring added complexity to the manufacturing journey, as drug products often need to be transferred between different facilities and geographies.  

Current solutions for transporting pharmaceutical powders include fibre or plastic drums with flexible liners, which can pose challenges around the filling, sealing, handling and emptying of packages while maintaining sterility. Because of this, manufacturers are now investigating hybrid, single use technologies that can ensure the integrity of products while in transit as well as within the manufacturing facilities.

Split butterfly valve (SBV) technology is an established solution for the transferring of powders (including drug substance and drug product) during bioprocessing. Consisting of an active and passive half, the active half is connected to the biomanufacturing process, while the passive half is connected to a filling container.

A disposable version of the passive half of the valve now exists, which can be connected to a single use flexible bag to enable the contained and sterile transfer of pharmaceutical powders between manufacturing process steps and facilities. Such hybrid solutions provide a flexible means of powder transfer, while also removing the time and cost associated with cleaning, maintenance and validation.

Ensuring single use solutions are manufactured with high levels of quality control within an ISO6 cleanroom environment as well as being gamma sterilised, makes the new hybrid solutions ready for use in aseptic processing.

Final thought

Whilst traditional single use technologies claim to deliver the same level of performance as some of the more traditional multiple use solutions, the reality is that this is not the case. The hybrid solution of the SUP and the active part of the SBV delivers repeatable performance as well as other advantages to pharmaceutical manufacturers. The convenience and control benefits associated with pre-validated, ready to use solutions, that are easily integrated and perform to the highest level of containment and sterility assurance, are invaluable. As the bioprocessing market continues to thrive, it is expected that new innovations will continue to focus on the challenge of product sterility without compromising manufacturing efficiency.