Boosting training in single-use technologies through vendor and end-user collaboration

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Collaboration in BioPhorum can bring many benefits to member companies. There are the usual cost and schedule improvements but also the quality aspects of manufacturing biopharmaceutical products, which are shared between biomanufacturers and their supplier partners they rely on for raw materials and single-use technologies (SUTs).  

This can even be seen in the area of workforce training, especially for SUTs. Making the most of these new production processes involves shared training between the supplier and the end-user to ensure their effective deployment. This is where training itself can benefit from emerging technologies such as virtual reality (VR). 

However, grasping the opportunities of this technology means companies may need to work with their suppliers to learn about identifying the training gaps around SUTs, understanding operator training needs, the importance of VR training tools and their role in agility and interconnectivity, and training for the visual inspection of SUTs. 

All of this and more is covered in a new article titled Facilitating Workforce Development: A Case Study on Improving Single-Use Training Through Vendor and End-User Collaboration, published in BioProcess International

It was written by Michael Moedler, Head of Training at Lonza Biologics Operations, and Hélène Pora, Vice President of Technical Communication and Regulatory Strategy at Pall Corporation. They discuss a range of critical issues that influenced a joint piece of work to develop a fit-for-purpose SUT training program. 

The authors suggest that collaboration between end-users and suppliers on SUTs has increased tremendously in the past few years, and the efforts of industry groups such as BioPhorum have played a major role in supporting this. 

“Over recent years, BioPhorum has had a very specific focus on SUTs by bringing together biomanufacturers and SUT suppliers to develop industry’s first five-year plan that ended in 2021,” said Moedler and Pora. “One of the aims of BioPhorum’s Supply Reliability Workstream was to look at reliability when using SUT, and a key action was bringing us together to discuss operator competence.” 

BioPhorum plans to raise the level of understanding of how to use SUT to the same level as stainless-steel systems, while the work of the original five-year plan is continuing across the Drug Substance and the Supply Partner Phorums. 

The potential for single-use bio-container breakage (e.g., due to shipping or handling errors) is one of the main reasons why biomanufacturers have not implemented SUTs more widely. BioPhorum estimates that leakage can cost between US$50,000–$20m+ depending on the type of bag and the material it contains. 

Training can also have a significant impact on this cost, and “we expect to see a 50% reduction in wrong handling, from unpacking to disposal,” Moedler and Pora predicted. “However, we should not forget that when handling hazardous materials, leakages can also have a significant impact on employee safety.” 

The authors say that VR also represents a sustainable approach to training, one that integrates fully within Industry 4.0 principles and the BioPhorum Digital Technologies Roadmap. However, those looking at SUT training should consider a blended approach that could include hands-on and digital learning, and support from interactive simulation technologies. 

“It is not only VR but also novel training methodologies like the one Pall used by combining different kinds of digital training, e.g., mixed-reality training platforms, to address scalability and fast deployment in biomanufacturers and suppliers. It focused on business needs, particularly the fast business growth in SUT, and bridging the gap between the qualified employees and trainers available on the market. Also, face-to-face training limitations in cleanrooms and Covid-19 restrictions further accelerated deployment.” 

Moedler and Pora added that BioPhorum helped Lonza, and Pall develop their VR training programs through inter-company collaboration. 

“This has been accomplished by giving us the opportunity to know each other and then inspiring us with workshops and best practice sharing within and beyond the biopharmaceutical industry.” 

They also suggested that further opportunities exist for the biopharmaceutical industry and that extended reality (which covers VR, augmented reality, mixed reality, etc.) can “accelerate collaboration far beyond training, e.g., virtual design works, proof of concept of new designs, factory and site acceptance tests and troubleshooting without traveling.”  

To meet cGMP requirements and ensure process quality, SUT operators need high-quality training to handle, install, and operate single-use production systems – but it is increasingly difficult to provide this. Also, as SUT adoption continues to increase, demand for well-trained SUT operators is growing faster than existing training infrastructures and methods can cope.  

Solving these issues will need new technology and extended reality solutions, and a collaborative approach between end-users and vendors that will improve SUT training and make their workforce development more agile and interconnected than ever before. 

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