Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference

By Todd Kapp, Kivi Bio

The Jan. 21 interchangeability conference hosted by Kivi Bio convened bioprocessing engineers, quality leaders, suppliers, and regional innovators to address one of the most persistent operational challenges in modern biomanufacturing: the interchangeability of single-use components and assemblies.

Drawing on frameworks from BioPhorum presented by Paul Schildgen, a principal process engineer at Catalent, and others representing industry standards organizations, the program explored how the industry can reduce supply‑chain risk, improve flexibility, and strengthen standardization without compromising quality or regulatory compliance.

The event blended national best practices with Wisconsin’s growing role as a bioprocessing and workforce development hub.

Key Themes And Insights

Interchangeability is about risk reduction, not plug‑and‑play

The event helped clarify what interchangeability really means in practice. Establishing interchangeability is often mistakenly summed up in geometry — one tri-clamp is just as good as the next one, and risk-reduction ends with dual-sourcing so that new parts are available when it's time to replace old ones. Those axioms provide a baseline, but interchangeability shouldn't stop there.

BioPhorum’s position, which speakers echoed throughout the event, is that interchangeability:

• is not a claim that two components are identical,
• is a structured approach to evaluating whether an alternative component can be used without re-validation of the entire process, and
• requires a risk‑based, data‑driven assessment across materials, dimensions, performance, extractables/leachables, and supplier quality systems.

In practice, this means interchangeability is a decision‑making discipline, not a shortcut. It is a framework for reducing operational risk while maintaining process integrity — and it demands cross‑functional alignment, not just engineering sign‑off.

Supply chain resilience is now a strategic imperative

The conference exposed a serious issue that, frankly, we don't spend enough time talking about. Suppliers and end users avoid speaking openly about risk. While the gathering offered a refreshingly candid chance to air out these ideas, conversations about risk should be happening more openly between sponsors and their contractors.

Speakers emphasized that the pandemic exposed deep fragility in single-use supply chains. Key points included:

• Manufacturers need qualified alternatives for critical components.
• Dual‑sourcing strategies must be built before shortages occur.
• Interchangeability frameworks reduce the cost and time of qualifying alternates.
• Supplier transparency and documentation remain inconsistent across the industry.

Frameworks are converging toward practical standards

The event summarized the latest work from BioPhorum and the American Society of Mechanical Engineers (ASME):

BioPhorum

BioPhorum published the interchangeability assessment and qualification best practice guide in 2025, which, among other things, addressed:

• Interchangeability decision trees — used to determine when a change triggers requalification.
• Component attribute matrices — mapping critical, major, and minor attributes to risk categories.
• Guidance on functional equivalence — defining when two components can be considered operationally comparable.
• Material characterization and process impact analysis — ensuring alternates do not introduce new risks.

ASME

Milena McFeeters, president of Refined Sciences and chair of the ASME Bioprocessing Equipment (BPE) Single Use Technology Committee, covered recent efforts by the group's single-use committee.

She discussed:

• standardized test methods,
• guidance on single-use component qualification,
• templates for supplier/end user communication, and
• advocacy for harmonized documentation packages.

Operational readiness requires cross‑functional alignment

The Q&A session emphasized that interchangeability is not just an engineering problem:

• Quality must define acceptance criteria.
• Procurement must understand technical risk, not just price.
• Manufacturing must validate functional performance.
• Suppliers must provide consistent, auditable data packages.
• Regulatory teams must ensure changes remain within filing boundaries.

Top Takeaways For Stakeholders

For manufacturers

• Build interchangeability matrices for critical single-use components.
• Establish pre-qualified alternates to reduce supply chain risk.
• Strengthen supplier audits and documentation expectations.
• Use BioPhorum/BPSA frameworks to standardize internal processes.

For suppliers

• Provide transparent, standardized data packages.
• Align with BioPhorum/BPSA guidance to reduce customer burden.
• Support customers with comparability testing and change notifications.

For educators and workforce developers

• Integrate SU system training into curricula.
• Emphasize risk‑based thinking and documentation literacy.
• Prepare students for hands‑on assembly, troubleshooting, and quality workflows.

But the most important takeaway is this: candid conversations about interchangeability and risk control cannot remain confined to conference summits. There is no one-size-fits-all solution.  They must become a routine part of how manufacturers, CDMOs, and suppliers work together to analyze risk and supply chain resilience. This is something that needs to constantly be updated and reexamined.

The January interchangeability conference, along with the combination of BioPhorum/BPSA frameworks and Kivi Bio’s regional mission, gave clear insight into how biologics manufacturers and their suppliers need to work together to achieve optimal results. Wisconsin is not just participating in the national conversation on bioprocessing risk management but helping lead it by bringing the parties together for a fruitful discussion.

About The Author:

Todd Kapp is the founder and chief executive officer of Kivi Bio, a life sciences consulting company in Kenosha, Wisconsin. He received an undergraduate degree in chemical engineering from the University of Connecticut and an MBA from Loyola University. Connect with him on LinkedIn.