Beyond the box: Device and packaging tech innovation vital for pharma

Our virtual CPHI Discover event (17th-28th May) is just around the corner, full to the brim with three main content tracks. Here, we explore the major trends in Drug Delivery and Packaging.

Demand for more effective and patient-centric routes of administration is producing a new generation of administration devices. Similarly, rules designed to secure supply chains are driving packaging developers to do more with the space available.

Drug delivery and packaging

A drug is only effective if it can be delivered in a bioavailable form. And an effective drug can only become a successful product if it can be packaged in a way that it is protected, stable and secure.

For effective delivery the challenge is choosing the technology that works with the drug being developed. Fortunately for pharmaceutical companies there are multiple potential routes of administration and delivery technologies available.

In addition, there is a rich and diverse ecosystem of delivery device suppliers and contractors working to create technologies suited to the evolving needs of patients and the pharmaceutical industry.

Alternative routes

At present, for obvious reasons, vaccine delivery is a particularly active area of research. The vast majority of vaccine shots are administered via injection. However, patient aversion is driving technology developers to assess alternatives.

Mucosal delivery has emerged as a focus of innovation. According to a recent study (1) advances in the production of purified antigens, combined with novel biomaterials and nanotechnology have enabled many innovative mucosal vaccine trials.

Nasal delivery (2) is another major area of research. The nasal mucosa offers easy access to part of the immune system that can stimulate other mucosal sites (3). In addition, there is already substantial experience in nasal administration for local indications, like allergic rhinitis, and niche areas, such as pernicious anaemia and pain (4).

Technologies

Interest in auto-injection devices is also increasing in both the vaccines sector and the wider pharmaceutical industry.

Recent analysis (5) suggests the global market for such products will grow 17.9% from 2020 to 2025 driven by the growing prevalence of targeted therapies, the rising incidence of anaphylaxis and a shift towards self-administration.

The analysts also predict patent expiry for biologics will continue to provide growth opportunities as suppliers seek to use auto-injector devices to differentiate their products.

On-body delivery devices are another area of innovation. The drive to reduce healthcare costs by minimizing in-patient treatment for chronic conditions has intensified the focus on devices that can be used in an in-home setting.

Programmable, variable dose on-body injectors are an example. Recent analysis (6) by the US Center for Biosimilars suggested companies working in the space will use on-body devices to compete against both the originator product and other biosimilar rivals.

Drug innovation

The pharmaceutical industry’s shift from the development of small molecule drugs to larger molecule medicines and cell and gene therapies is also fuelling innovation in the delivery technology space. A recent article in Nature (7) suggested growth of the commercial markets for advanced therapies has forced industry to adapt technologies and to develop new solutions.

And much of the innovation is coming from the influx of smaller start-up organisations entering the technology space according to recent analysis (8).

Packaging

The pharmaceutical packaging sector, like the drug delivery technology industry, is characterised by a high level of R&D activity and often the drivers are similar.

For example, the pandemic-driven surge in vaccine R&D has significantly increased demand for glass vials. Indeed, early in 2020 (9) there were concerns the glass manufacturing sector lacked sufficient capacity to cater for both increased demand from the vaccine sector and the wider biopharmaceutical industry.

In response – and with government support – production of glass has increased (10). Companies have also started using new materials. According to one study (11) glass that does not contain boron – an element that can volitize during vial production leading to the formation of flakes – has increased markedly in recent months. In addition, the authors suggest, demand for borosilicate-free glass has fuelled growth of an ecosystem of manufacturers and distributors.

Supply chain security

Concerns about drug traceability are another major driver of innovation in the pharmaceutical packaging sector. The desire to secure supply chains and combat drug counterfeiting has prompted regulators in most major markets to introduce tracking requirements for drug packaging.

In the European Union, for example, the Falsified Medicines Directive requires (12) that most prescription medicines have both a unique identifier - a two-dimension barcode - and an anti-tampering device integrated into their packaging.

On the other side of the Atlantic, the US Drug Supply Chain Security Act (DSCSA) introduced similar measures (13). The law also requires compels the pharmaceutical and packaging sector – by 2023 (14)- to use packaging as part of a system able to detect and remove potentially harmful products from supply chains.

Other trends impacting the pharmaceutical packaging sector include patient demand for usability and compliance, the need to enhance the stability of medicines and those that maximize potential shelf life.

Efforts to minimize drug waste are also shaping the development of the packaging industry. According to a recent study (15) active sensing technologies applied to pharmaceutical packaging could provide an “effective way for reusing medicines.”

Similarly, the global trend to reduce use of plastic is being felt in the drug packaging field. The challenge, according to a recent study, will be to find replacement packaging materials and to adapt established supply chains in a cost effective and sustainable manner.

Register for CPHI Discover here and check out the agenda for details of upcoming webinars and podcasts

References:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7149853/
2. https://www.tandfonline.com/doi/abs/10.1080/17425247.2020.1714589
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5287317/
4. https://www.aptar.com/resources/nasal-drug-delivery-past-present-and-future-perspectives/
5. http://www.globenewswire.com/news-release/2020/12/15/2145095/0/en/The-global-autoinjectors-market-is-projected-to-reach-USD-104-9-billion-by-2025-from-USD-46-0-billion-in-2020-at-a-CAGR-of-17-9-from-2020-to-2025.html
6. https://www.centerforbiosimilars.com/view/investigators-measure-pegfilgrastim-biosimilar-savings-potential
7. https://www.nature.com/articles/s41551-021-00698-w
8. https://www.startus-insights.com/innovators-guide/5-top-emerging-drug-delivery-startups-impacting-the-pharma-sector/
9. https://www.businessinsider.fr/us/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5
10. https://www.biopharminternational.com/view/increases-in-manufacturing-capacity-target-vial-and-syringe-shortages
11. https://www.fortunebusinessinsights.com/pharmaceutical-glass-packaging-market-104710
12. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview
13. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/are-you-ready-drug-supply-chain-security-act
14. https://econtrolsystems.com/blog/fda-track-and-trace-law-pharmaceutical-supply-chain#:~:text=The%20FDA%20signed%20the%20Drug,to%20the%20safety%20of%20patients.
15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7355753/