Life expectancy is increasing throughout the world, which is raising challenges for pharmaceutical companies. People now expect pharmas to provide ever-safer and more effective treatments to help them peacefully live out their senior years, and the industry’s players are working hard to meet these challenges against a backdrop of increasingly fierce competition. They are challenges that will only be met, however, if pharmas have high-performance production equipment enabling them to rapidly deliver drugs to the market, with zero health risks. And engineers are the ones they need to turn to for help.
The pharmaceutical sector is an industry unlike any other because the end-users of its products are not only consumers but also patients. But like any other industry it needs to move with the times and rise to new challenges. The first of these is of course meeting increasing demand for drugs and therapeutic solutions within a context of an ageing population, better healthcare coverage, higher demand in emerging markets and a widespread need for vaccinations in developing countries.
A highly competitive and regulated market
Pharmas need to not only design new and ever-more effective therapies but also to produce them and bring them quickly to market. This is where the industry’s second major challenge arises – namely containing manufacturing costs while being the first to offer an innovative treatment. Reducing time to market is vital as the first pharma to get their product on the shelves takes an 80% market share. Even if it has a therapeutic solution that is the same or very similar, the second-comer will only be able to capture 10% of the market.
Consequently, for an equivalent level of investment, the return on investment (ROI) is guaranteed for the first-comer but that is far from being the case for the second. This is specific to pharmaceuticals, because in other manufacturing sectors such as the automotive industry, an automaker like Peugeot can compete with Renault or Fiat a year or even two years after a similar model has been launched.
In the past, many pharmas earned their living from product licenses but in the age of generic drugs this is no longer possible. Just as Steve Jobs did with the iPhone, pharmas now need to constantly bring added value to their products, whether that be a higher-performing version of an existing drug or a brand-new treatment. The quicker a pharma brings a product to market, the quicker it can capture that market.
Although pharmas need to be inventive and rapid, the regulatory framework for their industry is becoming ever-more stringent. If a pharma doesn’t get the green light from one of the two major regulatory authorities – i.e. the European Union, with its guidelines on good manufacturing practice (GMP), and the Food and Drugs Administration (FDA) in the United States – then it may have to stop production.
And pharmas are now also facing additional compliance requirements related to data integrity. The increasing use of digital technologies – a prerequisite for meeting the first two major challenges described above – brings with it a need for safeguarding against the risks of intrusion and forgery. Pharmas have to be able to prove that their digital data is both unforged and unforgeable.
Operational excellence and cost optimisation
Engineers can help pharmas meet all of these challenges and Assystem has worked alongside pharmaceutical and bio-tech players since 1993. Drawing on our long-standing experience in the nuclear sector – another industry with very strict regulatory and security constraints – we have the necessary resources for helping improve time to market and optimising costs.
We have developed two specific tools for reducing costs and lead-times. One is an internal method called Global Risk Management. By managing a project based on risk rather than on time schedules or costs, our engineers can anticipate difficulties and avoid nasty surprises. For example, for a construction engineering project they can identify cases where no land surveys have been carried out in advance and warn the client of the potential risks of having polluted land before any contract is signed.
The second tool we use is Atlas – a software for monitoring and validating deliverables in real-time. This allows our engineers to work in fast track mode and therefore rapidly assess the production performance of deliverables and take any requisite measures to improve that performance.
Furthermore, in order to precisely meet the time to market challenge, our engineers work right from the design phase on devising equipment that is easy to put in place and get going. This may seem obvious, but in the pharmaceutical industry actually starting up a manufacturing facility can take just as long as building it. By having equipment that can be quickly operational, time to market can be shortened.
Pharmas and engineers – A win-win partnership
Engineers can incorporate the pharmaceutical industry’s specific quality requirements very early on in a project, thanks to URS (User Requirement Specifications). They use a process called Quality by Design which enables them to develop systems that don’t need a ton of adjustments before they can actually be rolled out and which factor in, right from the design phase, in-depth knowledge of the products and business processes concerned.
The earlier the quality controllers in pharmaceutical manufacturing facilities communicate their constraints to engineers, the more effectively engineers can take those constraints into account in order to size, install and automate the highly-specific equipment required. Because we’re not talking about simple manufacturing here but chemical or bio-tech processes that involve tanks, pumps, command and control systems, supervision and even ultra-filtration.
These solutions provided by Assystem’s highly qualified engineers already help our clients meet some of the regulatory requirements of the pharmaceutical industry. But Assystem goes even further as it employs engineers who are specifically trained in quality processes and product quality and have in-depth knowledge of pharmaceutical regulations. These engineers – who have a more academic profile – enable Assystem to add a very solid regulatory compliance perspective to its overall offering. They interact constructively and seamlessly with the other engineers working on the command and control, civil engineering, electricity and processes aspects of a project and they operate in direct conjunction with the manager in charge of the pharmaceutical manufacturing facility to ensure that all of the pharma’s requirements are met. This acts as a guarantee that the treatments produced will be accepted and validated by the regulatory authorities.
Providing support throughout a drug’s lifecycle – from the design phase to bringing it to market
It’s by combining all of these skills that Assystem has become a leader in Commissioning, Qualification and Validation (CQV). Our engineers can give our clients their in-depth expertise throughout a project’s entire lifecycle – from the facility’s design phase right through to its commissioning and maintenance of its machinery and equipment. By bringing together compliance and performance expertise with engineering services, they break down barriers between different disciplines in order to optimise time to market.
Our engineers also provide solutions to pharmas for their new data integrity requirements by developing computerised systems such as MES (manufacturing execution systems), which are hybrid solutions that meet both regulatory compliance and digitisation needs.
Assystem’s engineers in the pharmaceutical sector work both upstream and downstream of manufacturing activities, enabling our clients to produce the data they need for compliance purposes and therefore bring their drugs to market. They also partner clients in their manufacturing processes, from strategy right through to the operational phase, so that the pharmas can focus on their patients and their core business – a strategic approach that is helping transform the life sciences sector for the long term.