The clinical trials landscape has changed drastically over the last 10 years driven by demand for complex oncology drugs and medicines to treat a wide range of therapeutic areas. As a result, there is more clinical development activity than ever before.
Added to this, ongoing technological development in the clinical trials space continues to change not only the way clinical trials are managed, but also how the drug supply is developed, manufactured and packaged. In particular, companies are beginning to automate process lines as the need to improve productivity and still achieve high-quality results becomes more important to meet demand.
The average cost of getting a new drug to market is now estimated to be around £1.5 billion. If a drug fails in the late stages of a clinical trial, the financial and operational impact on the sponsor and its suppliers can be catastrophic. With this in mind, it’s easy to see why there is pressure from drug developers to reduce costs and timelines.
There are also wider cost concerns throughout the supply chain as a result of increased price pressures from governments. As such, pharmaceutical companies are looking for as many ways as possible to improve cost-efficiency and reduce the time to market.
With increasing focus on improving efficiencies to combat the cost and risk of clinical trials, adoption of automation is increasing among pharmaceutical companies and their contract partners. This is particularly common across packaging operations, in a bid to reduce the time and resources associated with manual processes such as inspection and labelling.
The benefits of automation
Packaging for clinical trials runs at smaller scale and frequency than commercial packaging, but this doesn’t mean automation can’t be introduced to improve operations. Companies just need to have a greater understanding of the investment involved in automating activity and the potential benefits it can offer.
In a clinical trial study, there are a number of ways automation can benefit packaging operation. Firstly, as a result of regulatory changes, labels for clinical trial supplies need to contain more detailed information, without having an impact on blinding of the product. As such, more companies are choosing to label their products using a barcode or a 2D data matrix that can be scanned at kit level.
In the same way that automation can benefit commercial packaging lines that need to incorporate serialisation data, it can also help companies develop efficient labelling processes that meet varying market regulations for clinical trials. This is where a company with experience of serialisation can really add value by translating this approach to clinical packaging lines to support the verification of assembly processes and provide suitable coding for despatch. It also provides an easy way to generate the randomised labels that are essential for successfully blinding products.
Specialised Interactive Response Technology (IRT) can also automate activities including clinical supply management and distribution. In addition, it allows for the adapting of the study schedule as data becomes available, which helps to drive overall efficiency.
Automated processes can also dramatically increase the speed of inspection activity. Clinical trials require each product to be identical in appearance as any variation could influence the results and invalidate the study. Technological advancements in camera vision and verification systems over the last decade have allowed companies to replace manual inspection with an automated equivalent to ensure uniform presentation of packaging and labelling.
Automation is also hugely beneficial when it comes to catering for evolving needs such as additional batches or scale-up. It can also make tech transfer simpler if the drug progresses to commercial supply. Capacity and scalability are vital and companies can benefit from using contract partners that can cater for both clinical and commercial supply, allowing sponsors to utilise the commercial technology for clinical projects and simplifying scale-up.
There is no doubt that automation can benefit packaging for clinical supply, however it’s imperative that companies ensure such processes are fit for purpose. Manufacturing and packaging for clinical trials tends to be a more manual process and sometimes very small scale, so for some projects, the investment in automation equipment will not be a viable option.
However, selecting a contract packaging organisation (CPO) with experience of packaging products from clinical to commercial supply can enable the sponsor to gain access to facilities and technology that will add significant value to the clinical project.