Bag leaks have long been a pain point for biomanufacturers, with the cost of a single incident ranging from €45,000–€511,000.1 To protect against such leaks, abrasions, tears and material fatigue, the Ultimus film has been designed using a proprietary woven nylon structure and provides enhanced bag strength, improved durability and resilience.
“We are committed to providing our customers with solutions that address their challenges in single-use manufacturing,” the company stated in a press release. “Our innovative approach of incorporating woven nylon ensures the film’s robustness while providing ease of handling, flexibility and conformity to a container that single-use processing demands.”
Maintaining the film’s integrity is crucial to ensure product quality, sterility and reliable manufacturing operations in single-use bioprocessing.
To achieve this, Ultimus film has undergone rigorous testing and demonstrated exceptional performance compared with the average results of five other single-use bioprocessing films.2
Ultimus film provides an animal-free contact resin that demonstrates a low extractable profile and supports healthy cell growth performance. This cutting-edge technology is now available in Mobius 3D process containers, delivering a stronger and more durable solution that improves operational efficiency while minimising disruptions.
Wishing to learn more, I asked Greg to expand on the thinking behind the innovation. “Driven by the need for improved flexibility, efficiency and contamination risk mitigation, single-use technologies are now widely used in biopharmaceutical manufacturing."
"However, when implemented at larger scale, biomanufacturers can experience challenges with the integrity of single-use bag assemblies owing to punctures, tears, abrasions, twists, cracks and delaminated bonds,” he explained."
“As a manufacturer of single-use products, we wanted to address these industry concerns and create considerably more robust bioprocess containers. To fully understand the specific customer challenges, we conducted extensive research to identify critical pain points."
"The findings guided the subsequent conception and development of an entirely new film as we realised that superior single-use products, particularly for large volumes, would require an improved material of construction.” Work then began on designing a film with the following attributes:
- strong and resistant to breakage
- capable of passing rigorous tests regarding extractables and leachables
- free from antioxidants that could impact cell growth
- clean from particulates to maintain fluid stream integrity.
End user benefits
Greg emphasised that the true innovation behind the Ultimus film was the way in which the design incorporates woven nylon for strength. “This was the first and foremost attribute that customers asked for,” he said.
“Nylon is a well-known polymer that has been used since the 1940s in various engineering applications when strength is required. Within the biopharmaceutical industry, for example, it has been used to make filtration membranes for decades.”
“As such, when we started developing our new film, we assessed nylon as a possible component and discovered that woven nylon provides a better combination of strength, weight and thickness compared with a simple nylon film. Whereas other films use nylon resin or thicker walled bags, the unique woven nylon structure in Ultimus film provides the perfect scaffold for the other film layers.”
“This innovative approach enormously improved the durability and strength of the film, without compromising ease of handling, flexibility and conformity to a container that single-use processing demands.”
The film is more resilient in terms of preventing leaks, abrasions, tears and material fatigue, as demonstrated when compared with the average results of five other single-use bioprocessing films:
- ten times more extreme abrasion resistance3
- 2.8 times more tensile strength3
- twice as much reinforced puncture resistance3
- superior flex durability3
- ISTA 3E Transport Test verified (using a Mobius 500 L Container with Ultimus film in a 500 L stainless steel transport bin).
“Healthy cell growth was another aspect important to customers,” added Greg, “so we made the film’s inner fluid contact layer free from antioxidants. This ultra-low-density polyethylene (ULDPE) fluid contact layer is free from animal origin components and also demonstrates a low extractables profile, addressing another key customer requirement.”
Expediting time-to-market
Business continuity is paramount for biomanufacturers, which means risk reduction throughout the supply chain is an ongoing priority. “For our customers, Ultimus film was designed to meet the needs of challenging single-use applications such as large-volume liquid processing,” said Greg.
“Having any leak in single-use bag assemblies during processing can result in product contamination and loss of a batch."
"Furthermore, leaks during processing can result in disruption, investigations and manufacturing downtime that could affect production schedules, timelines and costs."
"Delays in manufacturing can impact clinical trials and product availability in the market and may have financial or other business implications.” Ultimus film was designed to mitigate the challenge of leaks in single-use bioprocessing containers, thus avoiding disruption to manufacturing and helping to maintain business continuity.
Looking ahead
Today, Ultimus film is available in Mobius 3D process containers for large-volume fluid management such as storage and transport. Near-term future additions to the portfolio will include single-use bioreactors and mixers.
“However,” concluded Greg, “we see Ultimus as being more than just product extension, we see it as a revolution in single-use film. It has raised the bar regarding what we believe we are able to do in the single-use space and will enhance our future R&D efforts.”
“We’re confident that we can start pushing the norm for bioprocessing applications and bridge the gap between stainless steel and single-use systems. The development of Ultimus film is a step in the right direction in terms of becoming more efficient, economical, sustainable and accessible for the growing biopharmaceutical manufacturing sector.”
References
- www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/164/675/ultimus-infographic-mk.pdf.
- www.sigmaaldrich.com/campaigns/ultimus-film.
- Based on the average results of the five commercially available single-use bioprocessing films tested; www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/695/555/tb5661en-ultimus-film-tech-brief-mk.pdf.
