RESPONSIBLE MANUFACTURING IN THE AGE OF ANTIMICROBIAL RESISTANCE

Rex Clements, CEO at Centrient Pharmaceuticals, sheds light on the company’s e orts to contribute to a more sustainable global supply chain for antibiotics.

At Centrient Pharmaceuticals, we see responsible manufacturing as an integral part of our duty of care to our stakeholders. These include our employees, for whom we strive to provide a safe working environment, as well as the communities in which we build and invest. Likewise, we have a duty to our investors to ensure we act responsibly as well as profitably, and to uphold the policies and values of our local and regional government stakeholders.

As a leading supplier of betalactam antibiotics and other vital medicines, we also have a responsibility to our customers and, by extension, to the millions of people around the world who rely on our products. The first time our industry touches a patient’s life is often at the age of two or three months, when they are treated for their first small ear or throat infection. From that point on, they will have a lifelong relationship with our industry. Over the course of their lives, they may need access to antibiotics for routine surgery, childbirth, chemotherapy or a variety of other reasons. Given this fact, I believe the products we make are truly the foundation of healthcare.

Patients place their trust in our industry in other ways, too. They trust that the medicines they are prescribed are not only safe and e ective for their own use, but also created in a way that does not cause harm to the environment or society. At Centrient Pharmaceuticals, we are working to repay that trust – for example, through our focus on sustainable manufacturing technology. With our proprietary enzymatic antibiotics manufacturing platform, we have succeeded in reducing the carbon footprint associated with antibiotics production by up to 65% compared to traditional chemical-based processes, while eliminating the use of solvents and other chemicals. Our target is now for Centrient to become fully carbon-neutral by 2030.

Stronger Together

However, simply taking responsibility for our own activities will not ensure the long-term sustainability of our industry as a whole. With this in mind, we have recently started to license our enzymatic technology to other pharmaceuticals manufacturers, in line with our commitment to support the transition to a lower-carbon antibiotics supply chain.

Similarly, we are committed to being at the forefront of the industry’s fight against antimicrobial resistance (AMR). Without a concerted, consistent, industry-wide approach to this growing global healthcare problem, our products will eventually cease to work. In recent years, we have taken concrete steps to minimise our own contribution to AMR by improving wastewater treatment and effluent analysis methods at all our global manufacturing sites. And in 2021, we achieved our goal of meeting Predicted No-Effect Concentration (PNEC) targets for all of our oral antibiotic wastewater streams.

But ultimately, it makes no difference whether an AMR hotspot occurs at a Centrient Pharmaceuticals site or at one of our competitor’s facilities: either way, the long-term efficacy of finished dosage forms is compromised. The greatest weapon we, or any company, have in the fight against AMR is partnership. Centrient was a founding member of the AMR Industry Alliance (AMRIA), which now represents approximately 30% of the global human health antibiotics supply chain. Importantly, AMRIA has developed an Antibiotic Manufacturing Framework, which sets a benchmark for good manufacturing practice based on PNEC targets. In June of this year, I also welcomed the launch of an independent standard and certification scheme by AMRIA in partnership with the British Standards Institution (BSI).

The adoption of a common set of global criteria for sustainable antibiotic production is essential, taking this step ensures clear, consistent standards and a level playing field for all members of the value chain. Nevertheless, manufacturers like us still have a duty to monitor our own supply chains and audit them from top to bottom, as it is too easy for irresponsible practices to slip through the net. For example, a supplier may source its ingredients from a fully regulated, PNEC-compliant facility supplying Western Europe. But if that same company operates unregulated sites in other parts of the world, they may still be contributing to the spread of AMR. The onus is on us to take responsibility for what is taking place upstream; we need to understand the exact origin of the ingredients used in our products and only source from suppliers that are PNEC compliant.

Walking The Walk On Compliance

Authenticity is key. Talking about becoming a more responsible industry is all well and good, but to be of consequence, the steps we take to limit AMR and environmental degradation must be measurable, sciencebased and verifiable. Most importantly, our policies must be applied consistently, wherever we work and whomever we work with.

I am proud to lead a company that is fully embracing this approach. In May last year, Centrient Pharmaceuticals became the first member of the industry to publicly announce PNEC compliance for our entire oral antibiotic product supply chain. Perhaps more than any other achievement, this demonstrates our commitment to the responsible manufacturing of antibiotics. It also shows the role that sometimes lesser-known members of the pharmaceuticals value chain – in our case, a medium-sized, European-based manufacturer – can play. Given our influential role at the centre of the chain, it is important that we continue to make our voices heard by actively promoting best practices in sustainable manufacturing and sourcing. We must continue to encourage stakeholders at each point in the chain to join organisations such as AMRIA and participate in standardised, industry-wide certification.

The first step in solving a problem like AMR is to ‘own’ the fact that our industry is both part of the problem and part of the solution. By taking responsibility collectively and cohesively, we can help to build a sustainable future for antibiotics – ensuring they remain the foundation of healthcare for generations to come.