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Global Single-Use Network Supports Assurance of Supply

27 min episode · 2 min read
·
Gerard Brophy

Episode

27 min

Read time

2 min

Topics

Leadership, Software Development, Product & Tech Trends

AI-Generated Summary

Key Takeaways

  • Supply Chain Diversification: Shift from just-in-time to just-in-case inventory management by holding regional safety stocks near production sites. COVID exposed the fragility of centralized supply models, and manufacturers now require suppliers to maintain inventory within the same geography where production occurs, reducing disruption risk for critical consumables like polymers, filters, and tubing assemblies.
  • Single-Use Facility Advantages: Single-use systems reduce facility footprint, eliminate cross-contamination risk between products, and cut labor costs by removing cleaning and sterilization steps. For CDMOs running multiproduct lines, changeover between drugs requires no stainless steel decontamination, enabling faster turnaround and more cost-effective custom fluid-handling configurations matched to specific modalities.
  • Extractables and Leachables Characterization: For new modalities like mRNA vaccines requiring lipid nanoparticle production, organic solvents with high polarity demand full extractables and leachables profiling of every wetted surface in the single-use fluid path. Manufacturers must characterize spallation potential — particle generation from tubing — early in process development to avoid downstream product contamination issues.
  • Four-Pillar Regulatory Compliance Assessment: Evaluate single-use suppliers across four areas: clean room production environment with documented real-time temperature, humidity, and differential pressure monitoring; product sterility validation against ANSI, AAMI, and ISO 11137 standards; a formal Quality Risk Management program with executive-level reviews; and supplier-side audits covering management of change for upstream raw materials.
  • Quality Risk Management Program Structure: A supplier's QRM must include a risk register, CAPA and SCAR tracking, and measurable operational metrics covering on-time delivery, engineering drawing turnaround, complaint volumes, and manufacturing defect rates. Critically, the QRM must extend upstream to raw material suppliers, since undisclosed n-minus-two component changes have historically caused unintended failures in highly characterized single-use assemblies.

What It Covers

Dr. Gerard Brophy, EVP of biopharma production at Avantor, outlines how single-use systems in bioprocessing have grown post-COVID, and details the supply chain risks, regulatory compliance frameworks, and operational excellence strategies manufacturers need to manage these systems at commercial scale globally.

Key Questions Answered

  • Supply Chain Diversification: Shift from just-in-time to just-in-case inventory management by holding regional safety stocks near production sites. COVID exposed the fragility of centralized supply models, and manufacturers now require suppliers to maintain inventory within the same geography where production occurs, reducing disruption risk for critical consumables like polymers, filters, and tubing assemblies.
  • Single-Use Facility Advantages: Single-use systems reduce facility footprint, eliminate cross-contamination risk between products, and cut labor costs by removing cleaning and sterilization steps. For CDMOs running multiproduct lines, changeover between drugs requires no stainless steel decontamination, enabling faster turnaround and more cost-effective custom fluid-handling configurations matched to specific modalities.
  • Extractables and Leachables Characterization: For new modalities like mRNA vaccines requiring lipid nanoparticle production, organic solvents with high polarity demand full extractables and leachables profiling of every wetted surface in the single-use fluid path. Manufacturers must characterize spallation potential — particle generation from tubing — early in process development to avoid downstream product contamination issues.
  • Four-Pillar Regulatory Compliance Assessment: Evaluate single-use suppliers across four areas: clean room production environment with documented real-time temperature, humidity, and differential pressure monitoring; product sterility validation against ANSI, AAMI, and ISO 11137 standards; a formal Quality Risk Management program with executive-level reviews; and supplier-side audits covering management of change for upstream raw materials.
  • Quality Risk Management Program Structure: A supplier's QRM must include a risk register, CAPA and SCAR tracking, and measurable operational metrics covering on-time delivery, engineering drawing turnaround, complaint volumes, and manufacturing defect rates. Critically, the QRM must extend upstream to raw material suppliers, since undisclosed n-minus-two component changes have historically caused unintended failures in highly characterized single-use assemblies.

Notable Moment

Brophy reframes what single-use suppliers are actually selling: not tubing or process chemicals, but quality assurance. He argues manufacturers must be unconditionally certain that every supplied component performs within regulatory submission specifications, making quality the core commercial proposition rather than product functionality.

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Episode Transcript

Welcome to Gencast, a sponsored podcast series brought to you by Genetic Engineering and Biotechnology News. I'm your host, Jeff Pugaliskis. Over the past twenty plus years, single use systems have been steadily climbing toward the top of the tools utilized by bio manufacturers for the commercial scale production of critical therapeutic products. Yet much like for several other areas of the biotech and pharma industries, COVID nineteen created an inflection point for this technology, generating a significant demand that will shape the market for many years. Although with that considerable demand comes the need to focus on the key aspects driving growth and finding the appropriate solutions to challenges that invariably arise when technologies are being developed and utilized rapidly, a seemingly common thread throughout this podcast series. Now this is the third and final episode of Gencast where doctor Gerard Brophy, the executive vice president of biopharma production at Avantor, joins me. We sat down to discuss several essential facets of single use systems and some ways to help manage risk and decrease the intricacies most often associated with single use supply chains. This is an area of bioprocessing that has been of great interest to many of you in the gen audience, so I know you'll definitely want to keep listening. Thanks everyone for joining us for this third edition of Gencast with Avantor and doctor Jared Brophy. We are gonna be discussing some global single use network support assurance of supply today and kind of dive a little bit more deeper into the conversation that we started, two podcasts ago. So if you haven't seen any of those podcasts yet, please, do or say listen to those podcasts yet. Please do check those out. So, Jared, thanks for being with us again. Really appreciate it. Thanks, Jeff. Happy to be here. So, Jared, the first question I have is that there's been some rapid growth in single use systems in biopharma over the past several years. What do you see as the major drivers? There are quite a few. But if I were to pick two, it would be nimbleness and speed. Single use facilities just enable that. And that's especially important for clinical trial volumes of drugs and and also to mitigate those risks prior to approval. When you need significant amounts, but maybe, you know, you haven't got the time or necessarily the confidence to to double down on CapEx expenditure. But we also see significant advantages for single use with the emergence of new modalities. Think of things like viral vectors, gene therapies. And and, you know, those are emerging platforms, so the ability to change up process development protocols are are key, and single use just gives that more flexibility. For multiproduct lines, just think of CDMOs and CMOs where a new drug may need to be made on the same facility. You know, intuitively, you can understand how single use enables and supports that kind of flexibility of facility usage in …

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