The No-Brainer Alternative to Real-World Shipping Tests

The No-Brainer Alternative to Real-World Shipping Tests

The No-Brainer Alternative to Real-World Shipping Tests

“You don’t know what you don’t know.”

Why outsource your cold chain validation? Modality Solutions’ Advantage Transport Simulation Lab™ (TSL) can simulate the five main hazards associated with distribution: shock, vibration, temperature, pressure, and humidity. Our lab can simulate those hazards concurrently as they occur in the real world.

Why does it matter? The Transport Simulation Lab is beneficial because we can control the parameters precisely. We can ensure that we’re testing worst-case scenarios that may damage pharmaceuticals during actual transportation. Our tests simulate a worst-case, real-time scenario.

> Download: The Advantage Transport Simulation™ Brochure

 

Alternatives to Transport Simulation testing aren’t as reliable

When you conduct your studies with only real-world shipments, you cannot guarantee that it was completed with worst-case exposures. For example, you can’t specify your shipping carrier or how often a package is dropped.

The other alternative is to test sequentially. Sometimes companies will do a vibration test, followed by a temperature test, followed by a low-pressure test. None of these are happening concurrently. These other companies aren’t capturing the edges of the operating space. Instead, they’re capturing the worst-case scenario of each specific hazard and not looking at the potential effects on the product when hazards are applied concurrently.

Reliance on real-world shipments for Cell and Gene Therapies

There isn’t a lot of research on the impacts of vibration and shock on cell and gene therapies. So, companies are using real-world shipment tests to demonstrate that their therapies are robust to vibration, shock, and other transportation hazards. But again – these companies aren’t getting a concurrent, worst-case study using these shipment tests only.

Modality Solutions brings a sigh of relief that companies can conduct a transportation study in a controlled environment where they confidently know the exposures were conducted at worst-case parameters. Clients who test cell and gene therapies with Modality Solutions are more confident that their cell therapy will be robust after the transportation environment.

> Read Similar: The Impact of Non-Standard Transportation Methods on CG&T

Rely on Our Simulation Expertise

When companies attempt testing without help, they’re typically unable to ensure their testing applies real, worst-case scenarios, and they don’t have the resources to apply hazards concurrently. Companies are likely missing the potential impact on their products that could occur in the field because they didn’t see them during their own piecemeal or real-world shipment testing. That’s a big deal – because when companies miss potential impacts on their product, those potential impacts could harm the patient.

Regulators value the Transport Simulation Approach

The regulators appreciate Modality Solutions’ approach using the Transport Simulation Lab and our proven methodologies. By conducting these tests in a controlled, worst-case manner, it’s a one-stop study that answers quite a few different questions from the regulators.

The results from Modality Solutions’ experts (in conjunction with the lab) present the data and findings concisely for easy review and understanding. The Transport Simulation Lab smooths out the regulatory approval process, all while ensuring the product remains safe and effective for the patient.

The value of a partner with regulatory expertise

The team at Modality Solutions has significant regulatory expertise that is utilized in conjunction with the Transport Simulation Lab. We’ve had 300+ regulatory interactions in the past four years, and since 2018, over 80 drug approvals. That gives our team ample experience dealing with regulatory agencies and responding to information requests.

Modality Solutions has a 100% success rate with regulatory agencies and obtaining approval from a cold chain validation standpoint.

Outsourcing Cold Chain Validation for Clinical Trials

Modality Solutions utilizes this regulatory experience and success during clinical trial strategies. This type of simulation is beneficial to help aid in the formulation development of a drug product and to ensure your clinical trial results are reflective of the real world.

If you have a formulation that faces challenges during transport, you might see damage from the molecule. And if you don’t run those tests, or if you’re running them incorrectly and collecting inaccurate clinical data, you might never know.

 

Modality Solutions as a partner means peace of mind for clients and regulators

The regulatory process can feel daunting, but when clients engage a partner like Modality Solutions, they’re comforted that we’ve been there before. We make the regulatory process easier to navigate, and our Transport Simulation studies answer many questions from the regulatory agency that clients are often surprised at how much the lab facilitates their regulatory process.

Most commonly, we hear, “I never saw this coming.” Or, “we wouldn’t have figured this out ourselves.”

The Modality Solutions team is often consulted to help demonstrate robustness to shock and vibration – but clients are surprised that the study can answer other questions like container closure integrity, drug stability, temperature requirements, etc. It’s additional proof for regulators that a product is robust and stable in a transportation environment. Clients often quickly realize the value of working with a team like Modality Solutions to bring an advanced level of cold chain validation expertise and regulatory insights – especially in critical niches like cell & gene therapy. That’s when we excel.

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