Closed systems: Data driven equipment and facility design case study

This document reports on the learnings from bioburden reduction studies on hybrid (stainless steel and disposable) functionally closed bioprocessing systems developed over three years in collaboration with the Biomanufacturing Training and Education Center (BTEC) at NC State University.

The study sought to demonstrate that for low bioburden processes, operating a functionally closed system in a CNC environment is equal to or better than operating an open process in a grade C environment. This approach offers significant benefits for biopharma manufacturers in terms of capital and operational costs as well as reduced facility complexity.

The study concluded that measures as simple as flushing with WFI may be successfully employed to effectively mitigate the risk of assembling and operating a modern hybrid closed bioprocessing system in a controlled, non-classified environment. Over a five log reduction in bioburden was achieved with some cleaning agents.

The report argues that it is in fact superior to operate a functionally closed system in a CNC environment in this manner, versus an open system in a grade C environment as the potential microbial contamination from the environment entering the system would be lower.

The aim of the BioPhorum Drug Substance ‘Closed Systems in CNC Space’ workstream is to provide data driven arguments and risk based approaches to support implementation of closed or functionally closed systems, and to operate those systems within CNC environments.

Moving from inflexible operations in a grade C environment to a modern, flexible multi-product facility in a CNC environment will result in significant reduction in costs for the industry.

Such designs provide superior benefits like energy conservation, reduced facility capital and operating cost, shorter facility construction and qualification times, enhanced facility throughput and operational flexibility, reduced cost of goods and speed to market; all while maintaining the highest product quality standards.

Capital costs may reduce by 45 per cent and operational costs by between 50 per cent (energy) to 100 per cent (Environmental Monitoring) as per figures 1 and 2 (ref bioprocess international article 123):

However, to enable this shift to happen, the industry needs confidence from data, tools and processes born from risk based approaches that demonstrate it is acceptable to operate in this manner. One such area where data is lacking is other than steam, how can you render a low bioburden processing system functionally closed when open connections are made?

As such, the study was designed to assess what log reduction in bioburden could be obtained by flushing or cleaning open connections in a CNC environment to render a process system functionally closed. The results gained clearly demonstrate that this method of functional closure gives an acceptable reduction in bioburden, and arguably results in a lower amount of environmental contamination entering the process than a comparable open operation in a Grade C environment.

Organizations should now use this concept and data to develop their own cleaning development and validation strategy for their specific processes. This would support their own risk based approaches to implementing use of closed systems in a CNC environment

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Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

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Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

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IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

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There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

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This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

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AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

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