Within the clinical trials sector, there is an increasing demand for high-performing thermal packaging to meet the rising requirements of protecting pharma payloads, needing to be shipped at extremely lower temperatures. Consequently, thermal packaging vendors are responding to the growing trend to transport clinical trial materials at significantly lower temperatures including frozen, deep frozen and ultra-deep frozen.
The main driver for this rising demand for such specialist shippers is the rapidly rising rate of clinical trials being conducted. After the initial impact of the pandemic, the industry is now seeing multiple trials initiating from their first phase and successfully moving through all four phases. A clinical trial starts initially with an experimental treatment on a small group of often healthy people to judge a developed drug’s safety, and side effects and establish the correct drug dosage required. Through the second and third phases, the quantity of participants is increased alongside the emphasis on effectiveness. The fourth phase of a trial for drugs or devices takes place after the FDA agrees the trial results are positive and approves their use.
As a device or drug’s effectiveness and safety are monitored in large, diverse populations this can present temperature challenges for pharma payloads being deployed. Throughout all the phases of a clinical trial, the temperature requirement can change across, cryogenic frozen (-180°C), deep frozen (-80°C), frozen (-20°C), 2–8°C and even 15–25°C. As a trial moves through its phases, the quantity of participants increases as does the spread of countries these participants are located in. This presents considerable challenges from a logistics standpoint to ensure the drug remains at the right temperature. Clinical research organisations (CROs) need to ensure they can meet some if not all of these temperature requirements if they are to be chosen to manage the clinical trial. To do this they will need to assess the packaging options they have, and which packaging is the most appropriate to utilise to protect the valuable medical materials being shipped.
More recently there has been an increase in trials materials needing to be kept at a frozen temperature and this can create additional complications. There are considerations to take into account including what packaging is available within the industry, how does this packaging work and crucially, how long will it maintain the set temperature for?
The passive packaging options available are uncontrolled ambient, controlled ambient, refrigerated, frozen and deep frozen. Deciding what packaging to use will be based on the drug’s temperature stability, and the temperature band the drug can be exposed to without impacting its performance and effectiveness when administered. The majority of packaging being utilised for clinical trials will use foam and/or vacuum insulation panels (VIP) for insulation and a phase change material (PCM) for the engine and power of the packaging to maintain temperature. The different materials used will affect the thermal performance the systems can achieve with the following systems being used during clinical trial phases:
Uncontrolled ambient: A simply expanded polystyrene (EPS) box with no specific temperature control and large tolerance of drug stability.
• Controlled ambient (referred to as “controlled room temperature” or “CRT”): This would require EPS boxes with a PCM for a specific temperature requirement of +15°C to +25°C. (freeze point of phase material 20°C)
• Refrigerated: (freeze point of PCM 4°C) This would require EPS boxes with a PCM for specific temperature requirements of +2°C to +8°C. To maintain this demanding temperature a VIP would be used as the insulation.
• Frozen: (freeze point of phase material -20°C) This would require EPS boxes with a PCM for a specific temperature requirement of below -15°C. To maintain this challenging temperature a VIP would be used as the insulation.
• Deep frozen: Traditionally deployed would be EPS boxes with the use of dry ice for a deep frozen requirement of -80°C. Or for -50°C temperature requirements a PCM with an enforced VIP would be used as the insulation.
With all these various options available with variable performance and price points, it can be a challenge to decide what packaging to use. Many of these passive packaging solutions currently being deployed within the marketplace have an extensive qualifications to demonstrate their cold chain capabilities.