Integration of a Single-Use Platform Process within an Innovative Facility Design - The combination of single-use platform technology with modular facility construction is a template for flexible manu

ADVERTISEMENT

Integration of a Single-Use Platform Process within an Innovative Facility Design
The combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.


BioPharm International Supplements
Volume 25, Issue 11, pp. s27-s32

INTEGRATION OF PROCESS AND FACILITY


Figure 4: Systems integration architecture.
Systems integration is one of the key elements in the start-up and on-going development of any facility. The future integration of process analytical technology, electronic batch records, and electronic inventory control are all features that should be iterative and not retrospective in any design. The autonomous clean-rooms are already equipped with all of the computing power and I/O structure necessary to interface into process integration and manufacturing execution (MES) solutions, such as Rockwell Automation's Factory Talk and PharmaSuite applications. The systems are built on modules of prevalidated software and are configurable to the multiple disciplines and needs of the bioprocess industry. An example of this type of systems architecture is highlighted in Figure 4.

CONCLUSION

Flexible environments and flexible single-use systems have eliminated many of the classical constraints on biopharmaceutical processes and have allowed designers the ability to design modular bioprocesses and easily house them in properly classified environments. The ability to repurpose, improve, change, and re-use these core elements of a facility, affects the industry from large pharmaceutical to small biotech companies. Whether planning new facilities, establishing first time manufacturing capabilities, or executing new supply chain strategies by decentralizing manufacturing, companies now have new options to consider. And as suppliers continue to develop innovative products and collaborate effectively, the closer the biopharmaceutical industry will get to achieving its future manufacturing strategies.

R. BARRY HOLTZ, PHD, is president of G-Con Manufacturing, College Station, TX,
, and DENNIS POWERS is director of integrated solutions, North America, Sartorius Stedim North America,
.

REFERENCES

1. K. L. Nelson, "Single-Use Technologies and Facilities," supplement to BioPharm Intl . 24 (11), s22–s28 (2011).

2. E. Greb and A. Drakulich, Pharm. Technol. 36 (3), 46–50 (2012).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Despite AbbVie Snub, Shire Says it Will Double Sales by 2020
October 24, 2014
Manufacturing Challenges of mAb Production: CHO or Plant Cells?
October 24, 2014
Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials
October 23, 2014
Pall ForteBio Releases Bioprocessing Contamination Detection Kit
October 22, 2014
Roche to Expand and Improve its Basel Site
October 22, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here