INTERPHEX 2026: Managing Data Integrity in a Multimodal Pipeline
Automated and single-use technologies are offering companies the transparency and agility needed for the newer, more complex drugs in the pipeline, explains Mike D’Avanzo from Alcami.
The rise of complex biologics and personalized medicine is pushing traditional stability testing and manufacturing protocols to their limits. In this exclusive interview ahead of INTERPHEX 2026, The Pharma Navigator sits down with Mike D’Avanzo, Vice President of Pharma Storage and Services at Alcami, to delve into the reasoning behind industry’s move to a management by exception model for stability data and the benefits of ready-to-use (RTU) components.
Long-Term Data Challenges
TPN: With more complex modalities entering the pipeline, stability protocols are becoming increasingly intricate. How is the industry managing the data burden of long-term stability studies for biologics versus traditional small molecules?
D’Avanzo: The biggest challenge in long-term stability is not just generating more data. It is managing large libraries of samples over many years and being able to demonstrate, at any point in time, exactly what happened to each one. That requires clear, defensible records of when samples arrived, were set, where they were stored, when they were pulled and shipped or moved, and how any deviations or unexpected events were handled.
Biologics increase this complexity. They are typically more sensitive, require colder storage conditions, tighter shipping controls, and often more frequent transfers between facilities or testing groups. As a result, sponsors expect greater transparency in near real-time. This includes frequent inventory visibility, confirmation that samples were placed into the correct storage condition, and immediate escalation when temperature excursions or other risks occur.
Across the industry, the response has been to standardize and continuously improve stability operations through validated systems that automate as much of the routine work as possible and enable management by exception. Inventory tracking, shipping receipts, storage locations, scheduled pulls, and sponsor reporting are generated consistently within systems that prompt the required actions and maintain a complete audit trail. When exceptions occur, such as a freezer alarm or a change in storage condition, defined workflows ensure rapid notification, documented decision-making, and sponsor-ready records.
Small molecule programs are generally more straightforward because storage and shipping requirements are less demanding and study designs are more repeatable. However, as new and more complex modalities continue to enter development, stability is increasingly treated not as a static report at the end of a study, but as an ongoing service. That service is built on strong sample traceability, automated systems, faster communication, and continuous enhancement of processes that can stand up to regulatory and sponsor scrutiny over many years.
Small Batch Strategy
TPN: Additionally, the rise of orphan drugs and personalized medicine requires smaller, more frequent batches: How do you design a sterile fill/finish process that remains cost-effective when you aren’t running millions of units at a time?
D’Avanzo: For small batches, the cost of cleaning validation (CIP/SIP [clean/sterilize-in-place]) for stainless steel can outweigh the cost of the drug itself. Our strategy is to use disposable manifolds, bags, and filling needles. The benefit of single-use-technology (SUT) eliminates the need for expensive cleaning cycles, reduces the risk of cross-contamination between different orphan drugs, and allows for much faster changeovers between batches.
In addition, by using RTU components, we bypass the need for large-scale washers and depyrogenation tunnels, which helps reduce the physical footprint of the line and the utility costs (WFI [water for injection], electricity), making small runs financially viable.
Exciting Conversations
TPN: Finally, what are you most looking forward to at INTERPHEX 2026?
D’Avanzo: What we are looking forward to most is the chance to reconnect and collaborate with peers across the industry, comparing notes on what’s working in real-world environments, and making new connections along the way. We’re especially excited for conversations with clients: listening to what they’re prioritizing this year, the challenges they’re working through, and where we can partner more closely to help them move faster and with confidence.
Ultimately, that’s what keeps us energized about the week, everything we share and build together at INTERPHEX is in service of the same outcome: supporting the delivery of safe, reliable medicines for patients.
Alcami will be exhibiting at INTERPHEX 2026 and can be found at stand #4116.
About the Interviewee
Mike D’Avanzo is Vice President of Pharma Storage and Services at Alcami. Mike has been part of Alcami’s Pharma Storage and Services team for more than 10 years, working alongside colleagues across quality, operations, engineering, and project management. In his current role, Mike helps lead the growth and strategic expansion of our GMP pharmaceutical storage platform and our commercial validation and calibration services.
As a team, Alcami focuses on building scalable, compliant solutions that protect critical materials, manage risk, and keep programs moving efficiently from development through commercialization. Mike has more than 15 years of experience in life sciences storage, logistics, and biorepository operations, including large-scale cold chain, warehousing, stability storage programs, and commercial calibration and validation services.
At Alcami, Mike has had the opportunity to work with a strong team to build and grow a national storage and services platform that aligns infrastructure, quality, service, and commercial strategy with what clients need to serve patients reliably and safely.
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