Disposable Technologies for Fill-Finish of Clinical-Trial Materials - Pharmaceutical Technology

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Disposable Technologies for Fill-Finish of Clinical-Trial Materials
The author examines the use and advantages of disposable technologies in the fill–finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical-trial materials.


Pharmaceutical Technology
Volume 34, pp. s22-s25

Converting to a disposable system

Changing an existing reusable system to one that takes advantage of disposable technologies may not always seem to be an attractive option. The investment already made in existing equipment may restrict the implementation of disposable technologies in some facilities. However, even if it is considered to be impractical to invest in an entire disposable system, advantages can be gained from introducing elements of the disposable systems previously described. For example, increasing the use of disposable vessels (e.g., glass or plastic bottles and flexible bags) will potentially decrease turnaround times by reducing cleaning requirements.

Conclusions

Disposable technologies in the manufacture of clinical supplies of biopharmaceuticals offer the benefit of reducing cost, time, and risk. Some disposable technologies can be introduced into an existing facility quickly and at minimal cost. Savings can be achieved in the manufacturing process, and time efficiencies can be realized. By taking advantage of the removal of the requirement for cleaning verification when a fully disposable manufacturing equipment train is used, the time to get the product to the clinical trial can be reduced by as much as two months. For some companies, this improvement may be the most significant benefit of all.

References

1. A. Sinclair and M. Monge, BioProcess Intl. 3 (9), s51–s55 (2005).

2. M. Fuller and H. Pora, BioProcess Intl. 6 (10), 30–36 (2008).

3. G. Hodge, BioProcess Intl. 2 (5), 74–80 (2004).


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