Packaging
other important considerations, especially across multiphase or extended trials, or when trialling expensive biologics that have a limited use-by date. Packaging designers need to cover all supply chain eventualities that may arise over the life of the trial – from mitigating the impact of lower volumes and higher costs for smaller trials, to having strategies to manage unexpected or suboptimal trial enrolments and the consistency of packaging across delayed or extended phases of research. Not only do these challenges have budgetary implications, they can also affect trial integrity. “You need to have a strategy for your pipeline so you can solve these types of issues,” says Hastings. “If you don’t, you end up scrambling for solutions that are less than optimal.”
Trial and error: even the most subtle differences in packaging for placebos could jeopardise trials.
“There is always a need for human factors testing for a combination product,” Hastings says. “By this I mean the need to prove the design facilitates the correct use of the product.” Trials of combination products are focused much more on the needs of the user and the need to gather data on successful use of the product, in addition to the actual product efficacy. “This has driven us to think much differently on the secondary packaging design for combination product trials, with less hiding of the product and more emphasis on facilitating use,” says Hastings.
“There is always a need for human factors testing for a combination product. By this I mean the need to prove the design facilitates the correct use of the product.”
In this respect, approvals and regulatory processes for packaging are usually of secondary importance to trial integrity, efficacy and collating user data when it comes to measuring trial outcomes. “Labelling in trials, for example, is much more study facilitator-focused, as opposed to in the commercial environment, where you have to satisfy the regulatory agencies, physicians, pharmacists and users,” explains Hastings.
Supply chain strategies
Even so, poor design can affect the integrity of all trials – not just blind trials – and there are areas in which packaging for medical trials requires the same robust protections that are present in the commercial arena. Protecting all medication and materials against damage during shipping and storage is one obvious example. Whereas large molecule medications are more reliant on cold shipment and storage, small molecule therapies are more robust. Expiration dates and shelf life are
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He says it can be a good idea to create standard packaging target designs of different sizes for specific product lines.
“For example, HDPE bottles for small-molecule, vials for steriles and biologics, etcetera,” Hastings explains. “These would be designed for production lines and be pre-qualified on them.”
JIT manufacturing and customisation Trial designers are increasingly experimenting with just-in-time (JIT) manufacturing and customisation to minimise some of the costs related to smaller or multicentre trials.
“There is potential for reducing costs and adding flexibility with the JIT concepts, as you can more efficiently direct supply to studies where enrolment is higher than expected versus having a pre-labelled product that is not used due to low study enrolment,” says Hastings.
Such innovations should be written into trial protocols to safeguard processes for utilising partially packaged products that are labelled and shipped on demand. Here, the identification and tracking of products can pose additional challenges if tight guidelines are not followed.
Regardless of the protocol adopted, reliable and efficient manufacturing partners are essential. Hasting advises utilising standard equipment technologies that can be easily adapted from low to high-speed manufacturing. These often start out as small work cells with manual transfers in between activities, but they should be based on technology that can been automated as and when required. “The small high-mix [but] low volume type packaging areas can be very flexible and adaptable to the need of most trials, yet the technology is scalable to higher speed and capacity,” he says. “A lack of these solutions can lead to running inefficiently on high-speed lines and wearing the high costs that can be involved.” ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
VectorSun/
Shutterstock.com
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