NEWS

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

4 March 2022
Drug Substance
Supply Partner
Technology Strategy
BioPhorum

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.

NEWS
Forecasting the demand for single-use systems

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
Investigation Digital Workstreams
DOWNLOAD
Peer to peer practical guidance on remote inspections and audits
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
BioPhorum roundals on sugical gloves
DOWNLOAD
A visionary strategic framework for future patient-centric outbound biopharmaceutical supply chains
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
Lightbulb And Icons On Colourful Background
DOWNLOAD
BioPhorum environmental sustainability roadmap 2022
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing