Facility Tour: Advancing Inhaled and Injectable Product Development

Recipharm has integrated its capabilities to develop sophisticated drug/device combination products

Recipharm Logo

The path to bring a pharmaceutical product to market, from initial research to development to commercial-scale manufacturing, is a long and resource-intensive process.

Companies that provide product development services are increasingly looking to enhance or complement their existing capabilities. By adding new services and expertise to their core competencies that can better serve their current and future clients, service providers can move products through research and development and into manufacturing with even greater speed, efficiency, and quality.

Recipharm: A Global Leader in Pharmaceutical Manufacturing

A leading Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical industry with almost 9,000 employees, Recipharm operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US, and is headquartered in Stockholm, Sweden.

Recipharm offers a broad range of pharmaceutical manufacturing services, including the production of clinical trial material and APIs, pharmaceutical product development and the development and manufacturing of drug delivery devices. The CDMO manufactures several hundred different products for customers ranging from big pharma to smaller research and development companies.

In 2020, Recipharm acquired Bespak®, a leading provider of pharmaceutical drug delivery services. Founded in its current form in 1959, Bespak® Europe (Bespak®)’s initial focus centered around the manufacture of disposable products for the consumer market, supplying bottle dispensers for companies such as Unilever and Procter & Gamble. Bespak® took its first step towards becoming a pure-play pharmaceutical drug delivery devices company in 1968, when it introduced its first pharma product, a pressurized metered dose inhaler (pMDI) valve. This move was confirmed in 2002, when Bespak® officially exited the consumer market.

Recipharm was attracted to Bespak® due to its wide range of products and services, including device design, development, and manufacture. The acquisition enabled Recipharm to provide integrated services for drug/device combination products.

“Integrating Bespak® has enabled us to create an entirely new offering in device development and manufacturing,” says Chris Hirst, Head of Business Unit Advanced Delivery Systems (ADS). “The ability to manage formulation and device development as one single entity can significantly reduce device development lead times, resulting in much faster product launches. We’re also transferring innovative new products into commercial production scale.”

Chris continues, “Not only did Bespak® bring a portfolio of delivery device technologies to our organization, it also brought with it a team of highly talented industry experts able to enhance our inhalation and injectable services even further.”

Interrior of Recipharm Facility; Hands over machinery

Drug Delivery Device Solutions

Recipharm offers an integrated service spanning early phase development to commercial manufacture of inhalation drug formulations and inhalers, as well as injectable drugs and devices. Based in its King’s Lynn facility in Norfolk, UK, this branch is a key manufacturing center where inhaler and nasal devices are designed, developed and manufactured under the Bespak® brand, along with proprietary pMDI valves, actuators, and further components for use within the healthcare sector.

In addition to King’s Lynn, the company’s site in Research Triangle Park (RTP) in North Carolina develops formulations and analytical methods for inhaled pharmaceutical dosage forms, and the site in Holmes Chapel, UK produces clinical material in a pilot facility, together with filling and packaging finished dosage forms at commercial scale.

Chris explains why the combination of Recipharm and Bespak® is now providing tangible benefits to clients.

“We knew that devices and drug products work best when they are both designed alongside each other to complement one another. By combining formulation and device development in one system, we can reduce the development cycles and hence project lead times.

“Under a single entity, it’s also easier to manage the regulatory approval process and the day-to-day integration of the teams. The benefits to the customer are significant. Seamlessly, we can put the whole thing together and provide our customers with a perfect product, managing regulatory risks and time to market with significant patient and financial benefits with much faster product launches.”

Recipharm Facility Interior; Rows of roboshot machines

Recent Advances

A recent technology added to the Recipharm portfolio is the novel Resyca® soft mist inhaler (SMI), which falls within Recipharm’s range of proprietary technologies. Resyca® is a joint venture between Recipharm and spray nozzle manufacturer Medspray. “The Resyca SMI brings together the portability of a handheld inhaler device, with a gentle aerosolization method,” explains Peter Hirst, Head of Commercial for the ADS business unit. “The high forces at which many aerosolization devices operate tend to degrade large-molecule products, which lose their activity as a result.”

Peter continues, “With the Resyca® SMI, that’s not the case. The gentle aerosolization method means that the device is compatible with many large molecules. The Resyca® SMI is a very convenient delivery system for patients, particularly those who aren’t keen on receiving large-molecule products by injection.

For those large molecule products that do need to be administered by injection, Recipharm has developed a novel type of auto-injector that allows patients to self-administer challenging viscous formulations through very fine needles, thereby minimizing discomfort.”

“Our device specialists have excellent links with the early-stage development teams within pharmaceutical companies,” says Peter.

“As soon as those companies start to work with us to develop a new product, we’ll conduct initial feasibility studies through collaboration with our technical groups. As the device moves through development, we then think about pilot-scale manufacturing and further industrialization. Our New Product Introduction group will then act as a bridge to bring the commercial production up to speed in King’s Lynn, as we look to move towards full-scale manufacturing.”

Industry Expertise

Underpinning the company’s reputation for innovation is the company’s team of industry experts. “Our people are at the core of everything that we do,” says Chris. “It’s our multi-skilled teams of people who create value, whether it’s intellectual property, the design of the device, or the manufacture of the product. Within the last ten years, we’ve done a lot to encourage professional development within the organization, with a focus on improving the quality and service levels that we can offer to our customers and their patients.”

Making a Positive Impact

In addition to the critically needed pharmaceuticals that Recipharm produces, it is also making a positive impact in other areas, particularly in sustainability.

In 2022, Recipharm’s UK sites for the manufacturer of drug/device combinations targeting inhalation and injectables achieved a gold rating for sustainability from EcoVadis. Since 2007, EcoVadis has become a trusted provider of business sustainability ratings, creating a global network of more than 100,000+ rated companies. These sites were placed in the top 5% of all companies assessed by EcoVadis across a wide range of industries.

Recipharm’s King’s Lynn site is committed to becoming Net Zero by 2030, and has a plan in place to achieve this. Additionally, the Holmes Chapel site has installed solar power which will reduce carbon emissions by up to 227 tons per year.

Looking Ahead

Recipharm’s drug delivery device solutions are a key component to the company’s growth plans and within that unit the Bespak® brand carries a lot of equity through its portfolio of commercial products together with a range of pipeline products that will support future growth.

“We have a fantastic opportunity for growth in our respiratory products, be it oral, or nasal, and the same is true for our auto-injector based products, “says Chris. “To continue our growth, the priority is to remain focused on our customers and patients, becoming an even more customer-centric organization, while also driving improvement in everything that we do.”

Peter Hirst Head of Commercial – Advanced Delivery Systems. With over 25 years’ experience in the pharmaceutical industry, Peter brings a wealth of knowledge and experience to the Recipharm team. Having completed a PhD in Cystic Fibrosis lung infections, Peter worked in a number of organizations supporting the development of pharmaceutical products that utilize drug delivery technologies. Peter has experience working across a range of organizations from small biotech start-ups to large pharma companies.

Chris Hirst is Head of Business Unit, Advanced Delivery Systems. With over 25 years’ experience in the pharmaceutical industry, with 18 years spent working in the Recipharm business, Chris has worked in leadership roles supporting the development and commercialization of pharmaceutical products across multiple technologies and markets.

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