Let's talk about lab water
Let's talk about lab water
The pharmaceutical industry has been in something of a state of flux over the past decade. New business models, regulatory changes, healthcare challenges (such as an aging population), and growing demand in emerging markets, are all shaping the direction of travel. So where is the sector headed, and how will the industry use water – arguably its most important resource – in the future?
A shortfall in the traditional small molecule drug discovery pipeline and competition from generics, means that the era of Big Pharma’s reliance on ‘blockbuster’ drugs is over. To remain financially sustainable, many industry players have shifted their focus to new, large molecule biological medicines. In 2009, bioengineered vaccines and biologics represented just 17% of pharmaceutical sales. Sustained growth in this area means this is expected to increase to 27% by 2020.
However, these novel therapeutics pose a number of additional manufacturing challenges. Biological therapeutics are more susceptible to impurities in the production process than conventional small molecule drugs, and manufacturers will need to ensure production conditions are carefully controlled. The production of biologics based on monoclonal antibodies, for instance, requires a significant amount of ultrapure water for cell culture and downstream processing.
Other emerging fields such as nanomedicines and stem cell treatments are also posing specific challenges in terms of safeguarding manufacturing quality. Regenerative medicines, for instance, are based on tissue samples from the patient, and therefore many of the preparation stages will need to be performed in closed systems located at the point of care. The establishment of compact, sterile manufacturing facilities will be essential to ensure the highest levels of patient safety and treatment efficacy.
As new methods for assessing, approving and monitoring the safety and effectiveness of these medicines emerge, the regulatory licensing processes will evolve too. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) are now putting a much greater emphasis on post-marketing surveillance to ensure patient safety. The EMA, for instance, recently conducted a pilot scheme for ‘adaptive licencing’ where new therapies are granted licences on the basis of further testing to confirm their safety and efficacy in different patient populations.
For the pharmaceutical industry, this means that conventional approaches to launching products will likely give way to a phased approach where demand for a product increases as a licence is extended. However, as the interval between a product’s launch and sales peak grows, the time needed to recoup expenditure on manufacturing infrastructure will also increase. Therefore, rather than investing in a production facility designed to cope with peak demand from day one, a company launching a new medicine will increasingly require a flexible supply chain that can be quickly modified as the licence alters.
In order to manage these shifts in demand, manufacturers will likely need to deploy infrastructure that can be easily expanded. Conventional scale-up approaches, for example, could be replaced by ‘numbering-up’, whereby additional microreactors are added in parallel arrays. Modular water purification systems that can service these ‘Lego-like’ setups will offer advantages over fixed systems.
Of course, the pharmaceutical sector is not immune to the global environmental pressures facing industry in general, particularly around water usage. The UN predicts that by 2025, 1.8 billion people will be living in regions of high water scarcity, while 5 billion will be living under ‘water stress’ conditions. This problem will acutely affect parts of China, India and sub-Saharan Africa. With the pharmaceutical industry being a high volume water user, this issue will increasingly shape decisions around the future siting of manufacturing plants, particularly as these regions include a number of emerging markets.
For sustained growth, pharma will need to ensure it uses the best designs possible throughout the drug development process in order to minimise its water footprint. Energy efficient systems that make smart use of resources, such as those that can control flow rate depending on application, will have an important role to play in meeting these challenges.
As the pharmaceutical industry evolves to meet tomorrow’s healthcare needs, it’s clear that water purification technology will play a vital role. Increasingly efficient and flexible purification systems will be essential in order to provide the ultrapure water required for the sustainable production of innovative therapies. By working together with technology suppliers to overcome these challenges, the industry can continue to deliver safe and effective treatments to those that need them.