Modality Solutions provides advanced Cold Chain Regulatory Expertise

Modality Solutions provides advanced Cold Chain Regulatory Expertise

Regulatory Expertise – A Q&A with Gary Hutchinson

From transport simulation expertise to regulatory insights, Modality Solutions is the preferred engineering company for elevating pharma cold chain strategies. To maintain this stature, Modality Solutions’ work is consistently a core element of regulatory approvals – providing needed knowledge regarding the most recent trends in the regulatory pathway – a critical competency and reason why pharma companies work with Modality Solutions. Gary Hutchinson leads the team at Modality Solutions as co-founder and President; below he provides his insights into crucial service differentiators and how they provide unparalleled expertise.

Transport Simulation is preferred by agencies

Modality Solutions’ regulatory expertise can be extrapolated from our experience with transport simulation. We partner with pharma companies who demonstrate to regulatory agencies why transport simulation is a better answer for real-time shipment studies.

Many Information Requests can best be answered with the data provided by real-time shipping studies. Differentiating between real-time and real-world shipping studies in our responses to these agencies helps regulatory professionals view and understand the justification for Transport Simulation. From a regulatory perspective, simulation is a real-time study. Modality Solutions doesn’t accelerate the process or complete it at a faster rate than the “real-world” shipment. The product spends as much time in the simulation chamber as it would in movement in the “real world.”

When Modality Solutions can introduce the perspective that Transport Simulation is a real-time study when answering IR questions and explain why it’s the best route. That’s an expertise that not many other consultants or regulatory experts have.

 

Thermal Packaging Qualification

There are times when Modality Solutions partners with companies with difficulties in the OQ/PQ package. Either they can’t identify the difference between OQ (Operational Qualification) and PQ (Performance Qualification), or they don’t understand that data re-creation is unnecessary.

Data doesn’t need to be recreated because the pre-existing data package can be analyzed with an assessment report explaining why the data applies to your specific lanes and product. This expertise saves time, money, and the environment because we can mitigate the use of redundant lab testing and expensive shipments around the globe.

 

Information Requests Regarding the Timing of Verification Studies

Our team is also adept at responding to IRs that inquire about Transport Simulation studies and the timing of verification studies. We believe that the best practice is to complete performance qualification (PQ) studies post-filing because many items are defined within that filing. You’re able to perform verifications in specific commercial lanes with the third-party operators who are actually going to be handling the product.

We’ll commonly interact with Quality professionals who see PQ as the only possible way to test product quality in real-time, conflating real-world with real-time. This confusion would mean PQ studies have to be done pre-filing because you would need the real-time study as a requirement for the filing. Modality Solutions can explain that a simulation study is real-time, and a PQ is a verification study – we’re just verifying the actual lanes instead of representative lanes. (Typically, if PQ studies are performed before the filing, they’re completed in representative lanes with clinical trial logistics partners instead of commercial partners.)

When our team can talk through the quality and the regulations with the agencies, it’s easier to understand our preferred sequence. It’s the ideal sequence as long as you explain it appropriately – which is where Modality Solutions can provide a lot of value.

 

Regulatory insights that satisfy operational excellence and regulatory requirements

There’s a way to do things best-in-class from operational excellence (how things would occur in the supply chain) and a quality perspective (affirm regulatory and quality requirements in parallel). Regulators aren’t the enemy, and neither is Quality. They’re partners in this process, and their role differs from supply chain professionals…so the process doesn’t have to be antagonistic.

We’ve run into situations where supply chain professionals are being coerced into “doing the right thing” with needlessly complex and redundant testing and ignoring operational excellence. And it doesn’t have to be that way. Modality Solutions’ regulatory expertise allows us to support supply chain professionals working with regulatory and quality partners.

How to stay current with regulatory changes

Keeping up-to-date on Regulatory changes is a challenge. How is Modality Solutions the most up-to-date resource on regulatory changes and adjustments? Simply put, we are part of numerous filings. This focus lets us understand the nuances practically, as no agency consistently announces “we’re making a change!” to the regulations. It’s an evolutionary approach to pharma Cold Chain’s most up-to-date strategy.

Take the “c” or “current” label for things like Good Manufacturing Practice or Good Distribution Practice (cGMP or cGDP). The “c” identifies that the practice is evolving. It changes…and those changes aren’t always written down. (Our team jokes that c could mean current or even conversational in that it’s only by having interactions with multiple agencies multiple times that you’re getting this feedback of how they prefer the presentation of the data).

It’s difficult to predict what agencies are looking for…companies must connect a line that showcases their product and processes are under control.

That’s where Modality Solutions’ expertise is particularly valuable. We have weekly interactions with agencies worldwide; it’s hard to get any more current. We’re having conversations through our clients with the agencies to discuss ongoing expectations, such as “how do Monoclonal Antibodies look different than CAR-T cells.” Ongoing discussions in multiple modalities give us insight into where the agency is headed on expectations for the cold chain. I don’t know who else has that level of depth in regulatory expertise. Maybe there’s some company out there talking to the agency more often, but at a much broader level. But for specific cold chain regulations and their interpretations? I can’t imagine anyone else is having more conversations with the agency than Modality Solutions.

There’s a constant feedback loop. Data is presented. A response is written, and feedback is given, which informs the following response. Modality Solutions has gone through that feedback loop many times with various clients and datasets…each project has nuances in presentation, modality, and stability data. We are constantly updating and improving how the conversation should happen to increase the understanding of the agency and decrease the number of questions from the agency.

 

Bifurcating product quality validation & thermal packaging qualification

Modality Solutions pioneered the idea that product quality testing (and confirmation of quality during transport) should be done independently of thermal and even secondary packaging. Product Quality is the transportation environment and the interaction between primary packaging and the drug product. Thermal packaging, and in a lesser sense, secondary packaging, is fulfilling a different function. Thermal packaging is just there to help the product maintain the temperature within limits already tested.

Companies can’t design thermal packaging without tying the product quality attributes to the design. Some companies will approach packaging by creating a design that “makes sense” to their team. This approach has limitations because thermal packaging must be designed to a specification or user requirement. Companies need to answer questions about the temperature range and more. Too many professionals mimic packaging they’ve seen before, see that it held temperature during a shipment, and think they’re done.

Some professionals approach product quality and thermal packaging from a regulatory point of view. They put those two together and try to solve those problems simultaneously. But they’re two different answers, two different studies, and two different data sets utilized together to give the complete picture.

 

Reach out to Modality Solutions

Contact our team.

Our regulatory expertise doesn’t stop at these specific examples. At Modality Solutions, we are Cold Chain experts that can design, consult, and execute to support pharma companies through the approval process for their therapies. Our unrivaled track record with biopharma approvals, supported by our one-of-a-kind transport simulation lab, multi-disciplinary engineering expertise, and collaborative approach, make Modality Solutions the go-to partner for your biopharma cold chain engineering needs.