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Pharmaceutical Manufacturing and Packing Sourcer

Unstoppable Design

PMPS talks to Arnaud Fournier at Aptar Stelmi about the significance of stoppers in pharmaceutical packaging, the evolution of their latest product range and emerging trends within the sector

How has your background prepared you for your current role?

Arnaud Fournier: I have a strong background in market intelligence and a deep understanding of the global market for drug delivery devices used for parenteral applications. In addition, my experience in the elastomer industry allows me to work efficiently with our R&D, technical support and commercial teams on a global basis to design, develop and promote novel elastomeric closures for injectable drugs.

What initially attracted you to the pharmaceutical packaging industry?

The primary packaging industry for injectable drug applications is a very demanding and challenging space. It is exciting to work for a global leader and be exposed to multiple and different challenges given the variety of markets, therapeutic applications and technologies involved.

The relationship with pharma companies is unique. Meeting the specific needs of the healthcare market means paying attention to key issues, as customers and patients rely on quality products. In addition, the user is not just a consumer, but a healthcare practitioner and/or a patient (in the case of self-injection). Their expectations and preferences need to be understood in order to provide the optimal patient convenience and compliance.

And what is the biggest lesson you have learnt during that time?

To become a trusted partner in the pharma industry, it takes a lot of time and effort. Despite undergoing a lot of changes (for example, lack of genuinely new potential blockbuster drugs; development of targeted individual drugs for a smaller number of patients; shift to self-administered drugs and so forth), it is a conservative industry. As a consequence, incremental innovations in primary packaging are often preferred to disruptive ones. Suppliers need to be prepared and should adapt to these requirements.

Having said that, the globalisation and generalisation of the injectable drug delivery market is creating opportunities, and is a source of inspiration for novel practices that go well beyond new products. In summary, innovation can occur everywhere: in product designs, technical processes, business modelling, project management and so on.

You launched your PremiumCoat™ range of coated stoppers in 2015. What can you tell us about this product?

PremiumCoat™ is based on Aptar Stelmi’s success in developing products and solutions for the pharma and biopharma industries. It is a novel range of elastomeric components that are designed for the protection of sensitive and high-value injectable drugs. The technology used in these combines very pure elastomer formulation and a protective film, which is recognised and accepted on the market. During manufacture, the surface of the elastomer in contact with the drug is coated with a thin fluoropolymer film; this coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug formulation. As a result, compatibility of the drug and the closure is significantly superior with PremiumCoat™ elastomeric components.

How can a seemingly small component, like a stopper, form such an important part of the overall packaging?

Even though stoppers are small components, they are key in contributing to drug product safety and efficacy:

● Because the stopper is in direct contact with the drug formulation, it needs to be as chemically inert as possible to enable the drug to remain stable
● In addition, it acts as a seal to close the vial and protect the drug formulation from gas and liquid exchanges with the external environment
● The stopper is also pierced with a needle in most cases (although some stoppers used for diagnostic purposes are not pierced) to draw the liquid or mix the powder or freeze-dried cake with a diluent prior to injection to the patient Our elastomeric closures are designed for optimal protection and delivery of the drug, as well as for efficient processing on the filling lines. They meet a number of challenges such as: high chemical inertness, self-sealing, low gas and liquid permeability, resistance to coring while being pierced, and excellent machinability on the filling lines.

What challenges are involved in creating a sterile, protective seal?

When designing a sterile component, the best combination of elastomeric formulation and closure design, in conjunction with the mode of manufacturing the closure and of sterilisation, has to be chosen. Then, customers need to test the elastomeric closure and validate the sterilisation process to, ultimately, confirm the integrity of the packaging and thus the sterility of the products contained within.

What trends in the pharma packaging arena do you see emerging right now?

Like all the players in this field, we see the regulatory authorities strengthening regulations with the objective to better control the safety, efficacy and quality of drug products. Reduction of risks at all levels is also a key concern. These trends generate a demand for components that are cleaner, with tighter specifications. We also see a growing need for components to be used in isolators or restricted access barrier systems; this implies a fuel in demand for sterile components packaged in specific bags, adapted to this type of equipment.

Markets for cancer therapies, new vaccines, blood derivatives, hormones and several classes of drugs used in the treatment of auto-immune diseases, including monoclonal antibodies, are set to increase. Today, these high-value injectables represent half of pharmaceutical developments underway and require very expensive manufacturing processes. We have also identified a demand for film-coated closures particularly adapted to these highly sensitive biotechnology-derived drugs, which are difficult to develop.

Pharmapack is a big event in the pharma/packaging calendar. Are you launching any new products this year?

Pharmapack is a great event for Aptar Stelmi and Aptar Pharma. We have the opportunity to meet major actors of the pharma industry and discover innovative packaging and drug delivery solutions. We have been exhibiting at every edition since the very first show in 1999 and have also been a podium speaker at the conference event.

At the 2015 event, we unveiled our PremiumCoat™ line of products with a 20mm stopper. This year, the expansion of the range of PremiumCoat™ products with our 13mm stopper will be announced.

What developments do you hope to see within the industry over the next five years?

I expect a sustainable growth in the injectables market over the coming years. Further, I anticipate that current trends in the pharma packaging area, which were discussed earlier, will expand to new countries. The growth in biologics drugs and vaccines is leading to greater demand for pre-filled syringes and cartridges. One of the strong drivers for the increasing use of these is the patient’s need for safe and convenient self-administration solutions, leading to the expanding market demand for auto-injectors and pen injectors.

Patient safety related to medication infusion devices needs considerable attention to ensure the following: that the patient receives the right dose, will adhere to treatment, and can find help and support from their doctor throughout the treatment.

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