Manufacturing Chemist (MC) talks with Mark Hammond, Commercial Director at Aesica, about the many ways innovation can deliver measureable value across the entire process stream, gaining insight into the rapidly changing environment in which today’s pharmaceutical manufacturers are operating.
MC: How has the role of the contract manufacturer changed in recent years?
Hammond: It’s always been the case that contract development and manufacturing organisations (CDMOs) have had to stay flexible to meet the changing needs of the pharma industry. As Big Pharma has modified its business models, manufacturers have had to rapidly adapt to identify and meet gaps in the industry’s manufacturing capacity.
There’s been evident changes to the way pharma operates and each organisation has chosen its own preferred way to ensure that they are able to manufacture at the required capacity. They are either choosing to no longer manufacture in-house — streamlining their manufacturing capabilities — or turning to CDMOs, such as ourselves, for outsourcing, or creating a hybrid solution to meet their needs. Drug development budgets are under constant scrutiny and outsourcing has developed a reputation within the industry for being responsive to increasing cost competition. What pharma is now increasingly looking for is a manufacturer that can also offer product and process innovation. Active pharmaceutical ingredient (API) and formulated product manufacture is one area in which CDMOs with the relevant expertise and drive to innovate can provide significant value through true partnerships.
MC: Is it sufficient to just offer more capacity?
Hammond: For contract manufacturers, the changing industry landscape and pharma business models are driving expansion in terms of capacity, but also with respect to technical expertise and how they address industry challenges, including regulatory demands such as serialisation. It’s not just a case of capacity, but having the right capacity aligned with the right capabilities. Five years ago, demand focused on the bulk manufacture of simple formulations. Today, new product pipelines consist of more complex products. Legacy products also demand increased complexity, including late-stage customisation around packaging to enhance product lifecycles and to meet the demands of global patient populations.
MC: How do CDMOs bring innovation into the mix?
Hammond: In every industry, innovation is viewed as a must. However, the true value of any innovation is only realised when it is successfully integrated into the daily operations of an organisation. For many CDMOs, the standard way of working is to take a customer’s existing process and simply transfer it in-house. We are now seeing an increasing desire to work in partnership with pharma companies to provide alternative options for their existing processes. In these cases, we have to evaluate potential new approaches for a particular application or see how the technology can be adapted to meet specific requirements.
We have created dedicated facilities at both our Queenborough Development Centre and Cramlington site, with a key objective being to innovate in the API and finished dosage form space. Our vision is for these centres to be innovation hubs for our organisation, identifying, creating and sharing solutions that add value across all process streams — from API development and production through to the manufacture and packaging of finished pharmaceuticals.
MC: How does it work?
Hammond: Academia is a fantastic source of innovation and blue sky research, and industry is a great source of know-how regarding what technology can be exploited for pharmaceutical development applications, and the GMP capabilities and commercialisation expertise to progress a technology to market. CDMOs such as Aesica can bridge that gap between technology innovation, industry insight, development and commercialisation.
A partnership approach is a win-win opportunity. Innovators gain access to the development processing compliance and regulatory expertise, and in-depth knowledge of the pharmaceutical industry. By partnering with these innovators, we are able to offer new technologies that can potentially streamline the manufacturing process or provide solutions to otherwise costly and/or technologically tricky problems.
MC: How do you drive innovation across your organisation?
Hammond: Creating a forward-thinking, open-minded culture across the entire organisation is how we have been able to successfully adopt and develop new innovations. We create focused interdisciplinary teams that champion new technologies and innovations, and share best practice across all our sites. CDMOs need to give customers confidence that their services, capacity, technologies and skills will enable them to stay ahead of the game.
Quality of performance is a key requirement for customers and can act as a differentiator in the decision making process. There is an expectation that high quality operational excellence (OpEx) is standard practice for CDMOs, whereas we see it as a demonstration of commitment to delivering consistent high quality service. This service underpins growth, consistent quality and enhanced effectiveness, and an OpEx framework of techniques, structures and methodologies that are used to enhance customer service and deliver value. We have a member of the executive management team who has overall responsibility for OpEx, as well as a dedicated OpEx lead at each of our operating sites. We have drawn on expertise from both within and outside the industry, and engaged employees throughout every step of the process to develop an OpEx framework that resonates with all people, all processes and all sites. To us, it’s about having a culture and way of thinking that is applied to all processes, every day, supported by our people and core values.
Of course, being part of the wider Consort Group has enabled us to establish a single-source pharmaceutical services and drug delivery device business, following the integration with Bespak, a drug delivery device specialist. Our colleagues at Bespak remain at the forefront of inhaler and delivery device technologies through their dedicated innovation team, which has created strong links with academia. One exciting academic collaboration is using big data to investigate inhaler performance and inform new device designs, as well as predicting formulation performance. We continue to invest heavily in new projects and core infrastructure, most notably ensuring our packaging solutions are fully serialisation ready ahead of the forthcoming regulatory guidelines for key global markets such as the EU and US.
MC: Can you give more detail about your approach to serialisation?
Hammond: Being able to serialise drug packaging appropriately is a critical challenge for the industry to achieve in the next few years, as serialisation legislation is being enforced country-by-country as part of a global effort to counteract fake medicines. Legislation is already in place in countries such as China and South Korea, and is coming into effect in the US in November and the EU in February 2019 for all prescription medicines. Each country has their own legislation and specific requirements to comply with. For those who may not be aware, serialisation is the application of a unique randomised identifier onto a unit, typically a carton or a native bottle, of a pharmaceutical product and the capturing of that identifier to enable storage in a regulator’s formal database.
Serialisation will help to identify legitimate from fake pharmaceutical products, enable focused product recalls to be achieved more readily and, ultimately, contribute to improved patient safety. More than 6 years ago, we made a strategic decision to make sure we were fully prepared for serialisation, despite there being a lack of clarity at the time of what the requirements would be. To mitigate this uncertainty, we developed a modular approach to serialisation that is both flexible and scalable, creating a range of future-proofed solutions with different hardware and software providers. These have been implemented at all of our packaging sites across our organisation. We have been able to do this by developing a thorough understanding of the requirements with our in-house specialists, who have in-depth hands-on expertise gained during the last 4 years.
MC: Do you have any final thoughts to share?
Hammond: Historically, we focused solely on API manufacturing. We have expanded and broadened our scope considerably during the years to encompass formulation development and manufacturing through to commercial supply. Ultimately, we have to stay flexible to keep up with industry requirements, and have an eye on how the pharma operating environment is evolving, ensuring we adapt to meet evolutionary changes.
A forward-thinking, long-term strategy is allowing us to bring new technologies to market, and deliver products for our clients with a continued confidence in security of supply. Our innovation activities will continue to build pace and we will develop partnerships that will further improve our offering to the market place, bridging innovation and commercialisation.
And lastly, to say that serialisation is coming and as an industry, we need to be ready. Delivering serialisation solutions on time and on budget does not happen overnight. Our first serialisation solution went live in Italy in 2013 and, during the last 6 years, we have worked with leading hardware and software suppliers across Europe to create solutions that have been proven in the real world.