PROCUREMENT, SUPPLY CHAIN, AND SINGLE-USE SUPPLIER AUDITS

Q: How was the procurement process carried out at Roche?

Roche started with a technical evaluation and then with the vendor audits. We would not recommend this. When it comes to disposables, you need to do the quality audits first to make sure the supplier meets the basic criteria and then you can carry out engineering characterization with selected vendors. This will save time on the user side. You need to get the input of other departments early such as the procurement people addressing supply chain security issues before the technical evaluation. You need to focus the technical evaluation on parts that are limiting because they are outsourced from the vendors.

Our internal groups developed the URS for the hardware and we worked with the bag system suppliers to define the URS for the consumable part. On audits, we included colleagues from the automation department, and people from our internal disposables group for the consumables part (engineering, QA, and manufacturing). We had two years experience working with prototypes and had identified and removed the weak points.

Q: What problems did you encounter?

One of the issues is the immaturity of the supply chain. At the start of the project, we assumed we would get a reliable supply chain through standardization of disposable components and strategic stockpiling. This varies depending on the type of disposable. It is easier to achieve with bags for liquid handling, for example, where there are multiple vendors and the offering is not that different, and far more of a challenge for disposable bioreactor bags.

Q: In the future, would you validate two different suppliers to do the same duty?

Yes. We would combine the best bag systems with the best automation systems. This way, if there were a disturbance in the supply chain from vendor 1, we would have a second bioreactor that you could plug in.

CONCLUSIONS

Q: Having completed the project and implemented disposables, how satisfied are you with the overall results?

We have started routine production and finished the start-up phase. The experience with the start-up phase was very positive and there is a low failure rate. It is very important to involve operations as well as engineering in factory and site acceptance testing (FAT and SAT). A group of Roche users went to the suppliers for two weeks to get trained on the systems. Having been through this project, we could do it faster next time. [We had] very close cooperation with engineers from the vendors. SAT was done here. FAT was done over there. It worked very effectively.

Q: If you compare your experience with SSBs and SUBs from seed to larger scale, in terms of reliability and performance, are there any differences?

The ability to have multiple processes in SSBs is easier, because you can reengineer by yourselves in a day with stainless steel. You can't do that with disposables; it could take weeks or months to get a new design. Having said this, flexibility and overall capacity is improved with SUBs.

SSBs are more flexible because they typically can be reconfigured for yeast and microbial operations. Our SUBs currently are limited to mammalian use. But in terms of overall reliability, we have not really seen any differences up until now.

Q: Overall, do SUBs deliver on the published benefits? How do they compare to SSBs?

We benefit in terms of faster changeover times, reductions in the footprint of the plant, and the amount of clean steam and pure water required, [which] surpassed our expectations. The smaller footprint was achieved by rearranging the layout with disposables to fit in the existing building even though there were a lot of feedbags around the bioreactor itself. This enabled us to install the pilot plants in existing buildings. If we had stayed with stainless steel, we would have had to build a new plant, so the capital savings here are very significant.

ACKNOWLEDGMENTS

We would like to thank Barbara Jopp Heins of Roche communications for her active collaboration in preparation of this article.

Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494 793 243, disposables@biopharmservices.com
Monge is also the European chair of ISPE's Community of Practice for Disposable Technologies.

REFERENCES

1. Foulon A, Trach F, Pralong A, Proctor M, Lim J. Using disposables in an antibody production process: a cost-effectiveness study of technology transfer between two production sites. BioProcess Int. 2008 June.