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.
End to end support
As with traditional GMP manufacturing equipment, it is vital to plan to reduce downtime when implementing an integrated single-use production train.
Rapid GMP incident response processes, planned preventive maintenance and on-site rapid response teams should be part of the overall design. Zenith and GE are delivering together a comprehensive solution for the 24/7 support of GMP single-use production facilities.
This partnership combines GE’s bioprocess knowledge and global service reach with Zenith’s automation expertise to deliver rapid GMP incident response, root cause analysis and Corrective and Preventive Actions (CAPA) in collaboration with the GMP manufacturing clients.
Beyond the benefits for GMP manufacturers, the success of single-use is having a much broader impact. The lower cost and ease of use gives market access to start-ups who may not have the capital to invest in contract services or traditional manufacturing sites.
These companies are almost universally developing and manufacturing innovative and precision therapies, often targeting orphan and rare diseases for which no treatment has previously been available.
The flexibility and speed to market associated with single-use is also enabling entry into new markets for larger manufacturers and bringing increased capacity to others.
Three biopharmaceutical manufacturers have quickly entered the Chinese biosimilar and biologics market by deploying a single-use biomanufacturing process in one of GE’s KUBio modular facilities.
Additionally, contract manufacturers have realised the benefits of standardising their single-use production process and automation software to gain efficiencies in both tech transfer and production.
Ultimately, single-use is an agile technology that offers patients around the world better access to existing medicine and enables manufacturers to deliver these therapies faster.