Traditionally bound to internal R&D departments and processes, new pharmaceutical product development has suffered from inaccessibility issues and a lack of communication with external stakeholders, says Federico Piutti, Innovation Manager, Bormioli Pharma
Marketing glass and plastic vials, containers and closures for pharmaceutical applications in more than 100 countries around the world, packaging manufacturer Bormioli Pharma operates 10 facilities in Italy, France and Germany, and employs 1300 people. Having made “innovation” a key pillar in its company strategy by implementing a new “Bormioli Pharma Invents” programme — based on an open innovation approach — this represents a real breakthrough for the pharma packaging industry.
The advantages of open innovation — which means developing a distributed model wherein know-how is spread among internal and external players — are significant cost benefits derived from inbound input and reduced development times, and the ability to generate new revenue streams from spin-offs and licenses. All these savings significantly impact the “Innovation ROI.”
In 2019, the company implemented this model from scratch, managing it at both a strategic and tactical level. In terms of strategy, four pillars were identified — usability, connectivity, traceability and sustainability — all of which bring opportunities for growth as they relate to the main drivers of change in the pharmaceutical primary packaging market.
At a tactical layer, a cross-functional structure was introduced. At the top of the hierarchy, an innovation board was established (of which the company CEO is a member), and an Innovation Manager position was created to co-ordinate the overall activity and the different project streams.
This helped to boost the culture of innovation within the company, conveying the message that “a good idea could be come from anywhere, no matter the corporate function.”
Externally, partnerships have been established or consolidated with innovators, start-ups, universities and research centres. At the same time, the “listening phase” has been fast-tracked with ethnographic research involving both end users and professionals regarding the emerging needs of the pharma market and the type(s) of packaging required.
Just 2 years later, by applying a co-innovation approach, this model has already produced concrete results. For example, Plug is a dual-chamber system comprising a specific device containing the solvent and a bottle containing the API.
The system is able to protect the integrity of a formulation throughout its entire supply chain, allowing drug reconstitution and extraction with a syringe in a safe and effective way, avoiding the use of needles that could hurt consumers or professional users.
This concept was first presented at international trade fairs and then to customers and potential prospects. With audience feedback, a specific product development strategy was implemented that also incorporated external stakeholders. A primary pharma manufacturer then expressed a desire to further customise the container, transforming the original concept to address the needs of a specific drug.
Federico Piutti, Innovation Manager, Bormioli Pharma
The container has now been re-engineered to address those needs in terms of materials, host liquid, dimensions, simplification — reducing the number of components — and highlighting a brand-new user experience. Finally, further analysis has been done to verify the feasibility of commercial-scale production.
These developments not only allow the manufacturer to deliver a 100% tailor-made container, working first-hand on its engineering and implementation, but also means that Bormioli Pharma is able to offer an already industrialized product that can be scaled to different formats and sizes for a wide range of solutions requiring reconstitution.
Last but not least, it has enhanced Bormioli Pharma’s experience in the production of dual-chamber solutions for freeze-dried drugs, whose relevance is expected to rise in the coming years owing to the increasing number of biopharmaceutical products in the pipeline.
For example, among the list of more than 300 US FDA and EMA approved biopharmaceutical products, approximately 50% of them are freeze-dried — indicating this as the preferred way to stabilise biopharmaceutical drug products in an aqueous solution. In addition, the market for lyophilised drugs is projected to reach a value of $7.3 billion by 2025 (from $4.9 billion in 2020) at a CAGR of 8.2%.
The COVID-19 pandemic has taught us many lessons, one of which is that nobody wins alone. This means that partnerships will continue to be a fundamental driver of how we address emerging market needs and find solutions in the most efficient way.
I think this is a perfect example of how innovation can be converted into actual products by developing customised solutions to meet the specific requirements of pharmaceutical manufacturers, ensuring enhanced levels of safety and efficiency for end users, and also opening up new market opportunities in an emerging industry for pharma packaging manufacturers.