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Pharmaceutical Manufacturing and Packing Sourcer

Keep Your Cool

It is widely recognised that the economic downturn is finally beginning to improve; this can be seen across a wide variety of industries, with pharmaceutical development certainly being one.

Over the last two years, approvals of new chemical entities have continued to rise to a total not seen since the early 1990s. This is extremely encouraging news for an industry which has gone through a period of change, and feared it was facing a ‘patent cliff’. In 2012, the FDA alone signed off a total of 58 new drug announcements – an impressive rise on previous years. What is surprising about this figure is the increase in approvals of cold chain products needing to be managed at 2-8°C for storage and distribution. Products of this type made up almost 38% of all new drug announcements.

With a recent influx in speciality pharmaceuticals, orphan and oncology drugs and flu-related vaccines, this figure is likely to continue rising – and, along with it, the complexities of managing the drug product lifecycle for products with special requirements.

Maintaining Stability

Drugs requiring controlled temperature management must be handled in a manner that ensures product quality will not be adversely affected – this relates to packaging, labelling, storage and distribution. At all times, the maintenance of an effective cold chain logistical channel must be evident to ensure that medicines arrive safely in the hands of the patients for whom they are prescribed.

Drug stability programmes are an essential aspect of the drug development process. Stability is defined as the ability of a drug substance or product to remain within the established specifications needed to maintain its identity, strength, quality and purity. The results of such programmes are used to predict the overarching environmental effect on a drug product throughout its lifecycle, including during the packaging and distribution process.

As packaging and labelling is traditionally carried out in cleanrooms at ambient room temperature conditions, the industry and regulatory agencies recognise that drug products may be subjected to short-term temperature excursions. The stability tests support these excursions, and allow the study design to be maintained to suit the individual drug products.

However, stability tests are lengthy and costly. It is recognised that increasingly, temperature-sensitive investigational drug products have limited stability data available. As such, there is a growing need for projects to be labelled and packed within a refrigerated environment to maintain the drugs’ efficacy – due to the requirements of zero allowable excursions from a refrigerated environment.

Packaging and labelling in such an environment is not only about maintaining the efficacy of the drug product. There are other benefits that can be realised when choosing this method for packaging pharma entities.

Where stability information is available, storage, packaging and labelling is planned accordingly within the realms of this data. However, using a dedicated 2-8°C environment provides logistical efficiencies by simplifying the packaging operations and minimising risk to the drug product at all times.

Development Timelines

A key benefit to choosing a temperature-controlled environment for packaging and labelling can be demonstrated in a project’s timeline. The stringent management of the timed excursions required to package a temperature-controlled product at room temperature can add significant time to what can already be a lengthy and complex process. By electing to pack products in a dedicated 2-8°C facility, projects will realise significant efficiencies to the packaging lead times, allowing faster, as well as safer, patient delivery.

Conditioning of vials and syringes for labelling, staging for packaging preparation, and materials’ movements to and from the packaging line are all greatly reduced by performing packaging in a cold chain environment compared to removing product from refrigeration for allowable excursions, when packaging in ambient conditions. Reduced material movement also provides the additional benefit of reduced risk to drug products.

Finally, as drug development timelines and budgets are under continued pressure, both of the above benefits can also be attributed to delivering significant cost savings to a study programme. By choosing a supplier that can maintain an accountable storage and packaging process at the required temperature, costs can be reduced for packaging resources, product wastage and time management.

It is essential that at all times pharma companies consider the best study plan for their drug product and their patients. By considering temperature-controlled packaging as part of their study design, they are choosing minimal risk while achieving maximum efficiencies, and ultimately delivering a safer product faster.


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Tim Roberts is Associate Director for PCI’s Clinical Services in Europe. With over 15 years of dedicated experience in the area of clinical trial supply services, he leads PCI's clinical supplies team based in Wales, UK.
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