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Manufacture Packaging, Drug Delivery, Standards & Regulation, Quality & Compliance

Packaging the Future

I often feel that there’s a perception that packaging is not a particularly interesting subject – perhaps because drug containers don’t always look that exciting. Indeed, patients barely notice the container at all unless there’s a problem – but that’s the way it should be. If the package does its job properly then it should be invisible to the patient and this is the aspect that I find so exciting about pharmaceutical packaging; the products are understated and unnoticed, and yet they can make the patient’s life much easier. Visible to the patient or not, certain therapies would not have reached the market without innovation in packaging technology. The primary packaging container is essential for the efficacy and quality of the drug product, and has a critical impact on the product approval process. In addition, it also affects patient compliance because packaging is key to addressing the human aspects of product use – for example, by making drug administration easier, more convenient, or less painful. This is quite a complex aspect of packaging design, because it’s important to understand the needs of your targeted patient group and how to make the packaging fit those needs. Things that are easy for young people may not be so for older people, for example.

A growing number of packaging innovations are being seen in the pharmaceutical industry and it’s very much an evolving field at present. In the future, I believe that we will see new delivery methodologies that we can’t even dream about today. 

Containing biologics

Perhaps the biggest trend impacting innovation in packaging is the growth of biopharmaceuticals. Today, the 10 best-selling drugs are biologics, and by 2020 about 80 percent of all pipeline products are expected to be biologics. Just as these medicines are harder to manufacture than small-molecule drugs, they are also harder to package because they are so sensitive. For example, biologics can be very sensitive to environmental conditions, such as light or temperature, and the packaging components have a role to play in protecting the drug during transportation and storage. This is one aspect of packaging that is starting to receive more attention, but right now I’d say that there is a big focus on ‘clean’ ready-to-use packaging components that minimize interaction between the drug and the packaging material. Using the wrong material for the container can result in unwanted interactions with the drug product, which, in extreme cases, can be very dangerous for patients. It’s important for packaging manufacturers to produce comprehensive extractables profiles for their components. In addition, some manufacturers apply a barrier film or coating that protects against extractables. Broadly speaking, there is a lot of work being done to identify the right materials for making components and to give drug manufacturers confidence in their performance. In particular, quality by design practices – which have been adopted by both pharma and biopharma manufacturers – are also making inroads into packaging manufacture. After all, quality by design is about building in quality from the very beginning – such as meeting a quality target product profile determined at the start of the design project – and just as it can help produce better drugs, it can also help produce better packaging solutions better suited to their needs. This is particularly important as packaging components become more advanced to match the demanding needs of biologics – we need to minimize variations just as much as drug manufacturers do.

As well as developing effective containers for biologics, packaging companies also need to ask how the drug can be administered in a way that is both comfortable and convenient for patients. In some cases, a biologic medicine must be injected several times a day so it’s understandable why there can be issues with therapy compliance. There has been a big trend towards self-administration so that patients do not have to travel to a healthcare provider for their injections. Devices such as auto-injectors and pen injectors have become quite commonplace – and we’re also seeing innovations moving away from these traditional devices completely. For example, in the future you’ll see more ‘wearable’ drug delivery devices. We’ve been working on a wearable injector that is placed on the body that is designed to apply large volumes of a biologic drug over a certain time period. This is a very new and unique technology, called the SmartDose electronic wearable injector – and you can expect to read more in a future issue of The Medicine Maker. SmartDose is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical/biotechnology company..

Most patients don’t get overly excited about injections – therefore across the drug delivery field as a whole there is quite a large focus on alternative technologies to improve patients’ acceptance.

These sort of innovations are really important because they are better adapted to the needs of patients – generally speaking, most patients don’t get overly excited about injections – therefore across the drug delivery field as a whole there is quite a large focus on alternative technologies to improve patients’ acceptance and therapy compliance. There is also a move to make the package combine the functions of container and delivery system – an auto-injector acts as both packaging and drug delivery system, which is a good example of how the field of packaging is becoming more comprehensive. There are specific regulatory frameworks and quality expectations that apply to these combination products, but you should never overlook the human factor. The system should be effective, but it should also be easy to use, safe and convenient for the patient to help boost compliance.

There’s also a lot of potential for using mobile technologies to help promote patient adherence, such as by reminding patients to take their medication, or by educating them on how to take it (which is particularly important if a drug delivery device is more unique). I also think that there is potential for us to incorporate electronic features into packaging; for example, using a mobile phone to check that a drug has always been stored at a certain temperature without ever exceeding certain thresholds. I think this kind of connectivity will have a major impact on the packaging industry, as well as on the pharmaceutical industry as a whole.

Safe and smart

One issue that affects the packaging of all drug products – small molecule as well as biologics – is quality. Product recalls related to glass breakage or particulates are unfortunately more commonplace than you would think – and there is huge pressure from regulatory agencies to reduce these problems. On the other side of the fence, there is also constant pressure for manufacturers to reduce their production costs. This means that packaging companies have a bigger role to play – because one way for drug manufacturers to save costs is to outsource aspects, such as packaging component processing. The requirements for increased quality, however, are becoming more stringent all the time. This is a very well-known challenge – but that doesn’t make it easier to address. Some solutions are to invest in better clean rooms and in vision-inspection technologies, which are advancing really fast and can also be used by packaging companies to better ensure the quality of their components. This can help reduce the drug manufacturer’s rejection rates by around 1 or 2 percent, based on data points shared by customers. And although that doesn’t sound like a lot, it is significant when you consider the fact that a biologic can cost thousands of dollars. And of course reducing the chance of defects by even a small amount can still mean improved safety for patients.

Looking ahead, the key issue for packaging providers companies is how to better serve the patient by making products of very high quality in terms of administration and delivery. And related to that is the human factor; the critical issue of guiding and helping the patient with the therapy. Because even if you have the best drug in the world, it won’t be a success if they patient doesn’t take it correctly.

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About the Author
Mike Schäfers

Mike Schäfers is Vice President, Product Management & Marketing Operations, West Pharmaceutical Services.


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