Realising the potential of single-use technology

The GMP manufacturing adoption of single-use technologies is directly aligned with the need to increase productivity and provide flexible processing schemes that can adapt to the rapidly changing biopharmaceutical market needs.

The implementation of single-use technology in GMP manufacturing is growing rapidly. This is primarily because of the increased yields available using disposable technology, the growth of biosimilar approvals and the acceptance of personalised medicines.

Single-use equipment trains are also enabling innovative start-ups and contract manufacturers to rapidly produce clinical trial material, monoclonal antibodies (mAbs) or cell and gene therapies.

Here, David Staunton, Global Director Services at Zenith Technologies and Scott Ripley, Global Marketing Director at GE Healthcare, discuss the benefits of single-use technology and how patients are the ultimate beneficiaries.

Benefits of a single-use implementation strategy
Both upstream and downstream manufacturing processes benefit from single-use systems. They allow manufacturers to quickly add capacity at lower costs. They also make multiproduct GMP manufacturing easier to implement allowing facilities to respond quickly to changing supply demands.

When a comparison is drawn against stainless steel, the benefits of single-use technology are numerous. They include lower capital cost, greater flexibility, lower environmental impact as well as more efficient and quicker manufacturing practices.

Single-use technology adoption has led to reductions in capital investment by as much as 25–30% in some cases and increased speed to market by as much as 60%.

Contrary to common perception, the environmental footprint of single-use technology is also lower because of the reduced consumption of water, energy and chemicals used primarily in cleaning and sterilising stainless steel equipment.

The manual nature of single-use can make automation a challenge in GMP manufacturing environments. However, there are significant automation efficiencies created by having suppliers like GE deliver prevalidated and tested manufacturing control system (MCS) software with the equipment.

This GMP MCS software, complete with design specifications and executed test protocols, reduces commissioning time on site by avoiding the need to rediscover knowledge from project to project.

We are getting close as an industry to being able make "out of the box" purchases, not only the MCS with the single-use equipment train but also a standard manufacturing execution system (MES), digital dashboards and data analytics platform.

This will lead to improved regulatory submissions, more effective GMP Non-Conformance (NC) investigations and increased production capacity.

Increasingly, full upstream and downstream single-use manufacturing trains are being deployed by GMP manufacturers. These entire facilities include the delivery of the building fabric, production equipment, utilities and automation as one package.

An example of this is GE’s prefabricated KUBio. The KUBio is specifically aimed at reducing project timelines by incorporating the benefits of modular construction, single-use technology and prevalidated GMP automation software.