PCI Pharma Services - The complete package

Labelling and packaging drug projects in a refrigerated environment maintains efficacy, and provides significant logistical and cost efficiencies. PCI Pharma Services, a provider of contract packaging services to the global healthcare industry, leads the way in this burgeoning market.

It is widely recognised that the economic downturn has taken a turn for the better; this can be demonstrated across a number of industries, pharmaceutical development being one.

In the last two years, new chemical entity (NCE) approvals have risen to an extent not seen since the early 1990s. This is encouraging news for an industry that has gone through a significant period of change. In 2012, the US FDA 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, which made up almost 38% of new drug announcements.

With an influx in speciality pharmaceuticals, and orphan and oncology drugs, as well as flu-related vaccines this figure will continue to rise, and along with it the complexities of the drug product life cycle for compounds with special requirements.

Drug products requiring controlled-temperature management must be handled in a manner that ensures the product quality is not adversely affected. At all times the maintenance of an effective cold chain logistical channel must be demonstrable 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 capacity of a drug substance or product to remain within established specifications to maintain its identity, strength, quality and purity. The results of such studies are used to predict the overarching environmental effect on the drug product throughout its lifecycle, which includes the packaging and distribution process.

As packaging and labeling is traditionally carried out in clean rooms 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.

Temperature-sensitive investigational drug products have limited stability data available, and as such there is an increasing need for projects to be labelled and packed within a refrigerated environment to maintain the drugs' efficacy. Packaging and labelling in a refrigerated 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 of a pharmaceutical entity.

Timelines and cost-efficiency

When stability information is available, packaging and labelling is planned accordingly within the realms of this data. However, packaging in a temperature-controlled environment provides logistical efficiencies and will minimise risk to the efficacy of the drug product.

A key benefit of choosing a temperature-controlled environment for packaging and labelling can be demonstrated in a project's timelines. The stringent management of timed excursions can add significant time to what can already be a lengthy and complex process. By electing to pack the product in a dedicated facility, a project realises significant efficiencies to the lead times, thus allowing faster and safer patient delivery.

With drug development timelines and budgets under continued pressure, the benefits of choosing a controlled environment 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 in packaging resources, product wastage and time management.

It is essential that pharmaceutical 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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Cold chain products make up a large percentage of new drug approvals.
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