AI vs. Humans: Can Artificial Intelligence Outsmart Cold Chain Experts?

10 Common Misconceptions of Cold Chain Validation, as Explained by AI, commentary by Gary Hutchinson

Gary: Hello! I’m Gary from Modality Solutions – Managing Director and Co-Founder of Modality Solutions. In today's digital age, AI is revolutionizing how we access information. I wanted to test the waters and see how AI, specifically ChatGPT, compares to human expertise on a topic I know well: biopharmaceutical cold chain validation.

I put ChatGPT to the test with a common question:

What are the top 10 misconceptions about validating your biopharmaceutical cold chain?

During the exercise, I reacted and recorded my expert insights, along with a rating within a subjective system – much based on my gut reaction to each answer. This rating system is based on a scale of 1 to 10. The closer to 10 means the more accurate of a response – thorough, good breadth and depth, and perhaps “thinking” like someone with actual expertise and not just a data-crunching algorithm. The closer to 1 (in regulatory terms) means it’s “not for human consumption” – lacking proper insight, which would actually pose a risk to biopharma companies who try to use ChatGPT to drive their cold chain strategies. All ratings in between start to become a gray zone, but you get the idea.

Here's how the “test” progressed:

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Prompt to ChatGPT: What are the top 10 misconceptions about validating your biopharmaceutical cold chain?

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Answer from ChatGPT: Validating the biopharmaceutical cold chain is a critical process to ensure the safety and efficacy of temperature-sensitive pharmaceutical products. However, there are several misconceptions that can lead to confusion or improper practices. Here are the top 10 misconceptions about validating the biopharmaceutical cold chain:

Misconception #1: Once the cold chain is validated, it does not need to be monitored regularly. Ongoing monitoring and review of the cold chain are essential to ensure that temperature-sensitive products are consistently stored and transported within the specified temperature range.

Gary: I’m not quite sure this should be #1 - I guess I’ll have a job for a few more years at least. Monitoring and review are essential. Many clients have the monitoring covered but need some help understanding the important role of the management review process in the biopharmaceutical cold chain. And any management review requires well-considered key process indicators (KPIs) and relies on your corrective action and preventative action (CAPA) process in your quality management system.

My rating: 7 out of 10

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ChatGPT: Misconception #2: Validation is a one-time process. Validation of the biopharmaceutical cold chain should be conducted periodically or whenever there are significant changes to the process, equipment, or environment that could impact product integrity.

Gary: You could have tied #1 and #2 together and made a stronger case. However, linking a review process to periodic revalidation of the cold chain makes a lot of sense and is a best practice. Don’t forget to manage this process with your change control, too. Periodic evaluation is easy to forget but pays dividends down the road to make sure your cold chain stays validated and resilient.

My rating: 6 out of 10

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ChatGPT: Misconception #3: Validation only involves temperature monitoring. Validation of the cold chain may also include assessments of humidity levels, light exposure, vibration, and other factors that can affect product stability.

Gary: Absolutely! 10 out of 10! Since the advent of complex, synthesized, fully human proteins, like commercial therapeutic monoclonal antibodies, exposure to transportation hazards in addition to temperature (e.g., shock/vibration, humidity, light, etc.) are required to fully validate the cold chain.

My rating: 10 out of 10

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ChatGPT: Misconception #4: Validation is a complex and expensive process. While validation requires careful planning and execution, it can be tailored to the specific needs of the organization and conducted in a cost-effective manner.

Gary: The decision to support your cold chain validation process internally or to hire a subject matter expert (like Modality Solutions) is always challenging. We explain our value proposition during the scoping process and offer fixed-fee pricing and milestone-based invoicing, but we do get challenged on the cost on occasion.

Cold chain validation requires careful planning and execution. It should be tailored to the specific needs of the organization, the drug product, and its supply chain and can be conducted cost-effectively.

However, the remediation cost of the wrong cold chain planning and execution, along with the risk to the overall timeline, can make the decision to over-rely on internal expertise costly down the road.

My rating: 4 out of 10

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ChatGPT: Misconception #5: Validation is only necessary for long-distance transportation. Validation is important for all stages of the cold chain, including storage, handling, and transportation, regardless of the distance traveled.

Gary: While I don’t agree with the misconception that industry professionals consider validation only necessary for long-distance transportation, I do feel that there is the misconception that all lanes and all steps in the cold chain need to be validated.

The best approach, and the one advocated by most regulatory agencies globally, is to take a risk-based approach to validation. One size does not fit all, and formal risk assessment across the pharmaceutical supply chain can identify the highest risks to patient safety, regulatory compliance, and total delivered cost.

More importantly, a formal risk assessment can also identify low-risk processes that do not require validation but can be evaluated with downstream controls and periodically monitored.

Knowing which processes require rigorous validation and which can be safely included in your monitoring and controls strategy is the correct yardstick for a best-in-class validation strategy, not basing your approach on distance or time in transit.

My rating: 2 out of 10

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ChatGPT: Misconception #6: It is sufficient to rely on external providers to validate the cold chain. While external expertise can be valuable, it is important for organizations to have internal capabilities and an understanding of the validation process to ensure compliance and accountability.

Gary: I agree with this sentiment: internal expertise is critical to maintaining and improving the cold chain across the therapy's lifecycle. The value of external expertise can best be realized by ensuring a comprehensive ‘technical transfer’ of the cold chain expertise during the engagement.

We see our role at Modality Solutions to be more than engineering know-how and regulatory expertise, but a mentor and guide upon your cold chain journey to excellence. We want our clients to be successful long after the engagement ends and are ready to manage their cold chain processes with confidence.

My rating: 8 out of 10

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ChatGPT: Misconception #7: Validation is only required for high-value products. All temperature-sensitive pharmaceutical products, regardless of their value, should be subject to validation to ensure patient safety and regulatory compliance.

Gary: I don’t believe that any industry professionals believe that validation is dependent on the value of the product. I would like to bring up that there is an expectation that certain precursors and intermediaries, which can be a lower value than finished drug product, may require validation as well. The risk assessment should evaluate the entire supply chain, including raw materials, precursors, and intermediates, to determine the appropriate validation strategy.

My rating: 7 out of 10

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ChatGPT: Misconception #8: Validation is a one-size-fits-all process. Validation strategies should be tailored to the specific characteristics of the product, supply chain, and regulatory requirements to ensure effectiveness.

Gary: While I agree that validation is not a one-size-fits-all process, validation strategies should be tailored for many reasons besides ensuring effectiveness. We also recommend considering other factors, including efficiency, cost, and time to market, when designing a validation strategy. When these additional considerations are taken into account, a strong case is made for the use of transport simulation when evaluating the quality of drug products in the supply chain.

Another important consideration for validation strategy is flexibility. The validation process should be flexible enough to accommodate changes in technology, regulations, market conditions, and other factors. Companies need to be able to adapt their validation strategies as needed to address new challenges and opportunities that may arise in the lifecycle of the drug product.

Finally, with today’s distributed global supply chains, ensuring collaboration across multiple stakeholders has become increasingly important. An effective validation strategy involves collaboration among cross-functional teams within the organization, as well as with external partners such as contract manufacturing organizations, regulatory agencies, and internal stakeholders. A successful validation can build strong partnerships and communication channels across the supply chain that will pay dividends during commercial launch and beyond.

My rating: 3 out of 10

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ChatGPT: Misconception #9: Validation is solely the responsibility of the quality assurance department. Validation of the cold chain is a collaborative effort that involves multiple stakeholders, including logistics, operations, and regulatory compliance teams.

Gary: I completely agree. I probably should have read all of Mr. GPT’s responses before replying! For all the reasons above, a collaborative effort is necessary and a best-demonstrated practice.

My rating: 9 out of 10

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ChatGPT: Misconception #10: Validation guarantees product quality and safety. While validation is an important step in ensuring the integrity of the cold chain, ongoing monitoring, compliance with SOPs, and risk management practices are also crucial for maintaining product quality and safety.

Gary: Validation may not guarantee product quality and safety, but a strong, flexible, and collaborative validation strategy allows stakeholders to have a high degree of confidence in their cold chain. We talk to our clients about confidence intervals and risk, not guarantees.

My rating: 5 out of 10

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Conclusion

In my opinion, ChatGPT did an ‘okay’ job at answering the question about misconceptions in cold chain validation, but I wouldn’t rely on AI to set strategies or determine validation plans.

In today's rapidly evolving digital landscape, the emergence of AI technologies like ChatGPT has revolutionized how we access and share information. While ChatGPT excels at processing vast amounts of data and providing quick responses, human experts bring a unique and invaluable perspective. They ensure accuracy, context, and empathy in communication – aspects that AI can sometimes struggle with. Their deep expertise and nuanced understanding of complex topics complement the AI's capabilities, guiding conversations, interpreting nuances, and offering personalized insights.

In this symbiotic relationship, human experts act as mentors and facilitators, enriching the AI's responses with a human touch and wisdom. Together, they form a dynamic partnership that bridges the gap between technology and human understanding. This collaboration not only reinforces the irreplaceable role of human expertise in industries like biopharma but also demonstrates how AI can enhance and amplify human capabilities when used effectively.

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About Modality Solutions?

Modality Solutions is a leading provider of specialized services and competencies in the biopharmaceutical industry. With their Cold Chain Consulting expertise, they design, implement, and optimize cold chain processes, ensuring products are maintained within specified temperature ranges. They conduct thorough risk assessments to identify vulnerabilities and develop strategies to mitigate risks during storage, transportation, and distribution. Modality Solutions also helps clients navigate complex regulatory requirements, ensuring adherence to industry standards and guidelines. They offer Transport Validation services, developing customized protocols and testing procedures to validate the effectiveness of cold chain processes and conducting performance qualification studies to verify product integrity throughout the supply chain. Advanced data analysis provides insights into temperature excursions and deviations, empowering clients to make informed decisions. Additionally, Modality Solutions specializes in packaging solutions, supply chain optimization, regulatory expertise, advanced technology solutions such as simulation modeling and risk mitigation strategies, and nonclinical safety assessment programs. With their deep industry knowledge and technical expertise, Modality Solutions is a trusted partner in assisting clients to streamline processes, maintain regulatory compliance, and achieve fast approval for their drug products.?