Issue link: https://www.e-digitaleditions.com/i/1532595
16 Pharmaceutical Technology ® | BioPharm International ® Bio/Pharma Outsourcing Innovation 2025 PharmTech.com their existing franchises, by reformulating products with new propellants." Requirements and regulations Susta i nabi l it y reg u lat ions va r y f rom count r y to country and region to region, with Europe being es- pecially stringent. Every pharma company conduct- ing business in the EU is impacted by European sus- tainability requirements, Burns points out, as well as pharma companies importing products into the EU. But regulations are also different in countries like the United Kingdom, which is no longer part of the EU after Brexit, and the US. In the UK, the Association of the British Pharmaceu- tical Industry (ABPI) works with the UK government, the National Health Service, and stakeholders to ad- vance sustainability efforts. There are three categories of greenhouse gas emissions, as stated on ABPI's web- site: scope 1, which covers the emissions a company di- rectly makes; scope 2, which involves the emissions a company indirectly makes; and scope 3, which covers the emissions made by a third party the company is indirectly responsible for (3). Scope 1 emissions may be reduced by efforts such as a company generating its own renewable energy. Scope 2 emissions may be reduced by using renewable energy suppliers. Scope 3 emissions can be reduced by applying a life-cycle approach to manufacturing medicines in a sustain- able way (3). "[In the US,] we are operating under a quota system, which is just a reporting mechanism from the EPA [Environmental Protection Agency] at the moment, and any legislation that affects what we do is ver y much at the state level as opposed to the federal level," says Burns. "For instance, California has legislated to pretty much ban existing propellants from the be- ginning of the 2030s. In our industry, there are two different current propellant options, one which has a higher global warming potential will be effectively banned in California by the end of 2030, and the other propellant, which has a lower global warming poten- tial, will be banned by the end of 2032." Sterling continually evaluates its practices to in- crease sustainability and communicates information on these practices with stakeholders. "The differing requirements between the EU and United States do not dictate or restrict Sterling's activities in terms of sustainability," Peutherer says. "If actions are seen to be the right thing to do, these are implemented across the whole organization, rather than it being limited to specific geographies." His company also participates in initiatives such as EcoVadis, PSCI, the SBTi, and the United Nations Global Compact (UNGC). According to Harkin, Almac has aligned its sus- tainability strategy to the Paris Agreement. The com- pany committed in 2022 to be net zero by 2045 and to reduce scope one and scope two emissions by 50% by 2030. Almac has made milestones against their targets including joining the Science Based Targets Initiative, switching power at their global headquar- ters to renewable energy, and an investment in their supplier engagement program to reduce value chain emissions. The company also monitors changing regulations to ensure its practices align with the necessary re- quirements. "While the emphasis on sustainability has historically been stronger in Europe, the focus in the US has continued to grow. Although we see some differences in the requirements depending on geographic location, it's worth reiterating that both regions increasingly require evidence of sustainable practices when negotiating partnerships," says Harkin. Neuland Labs has worked ESG into their frame- work and core operating goals, according to Davu- luri, and officially formalized ESG goals in 2024 with short-term and long-term goals aligning with ESG priorities. "Coming up with these ESG-related goals is not just percolating them within the organization to our internal stakeholders, but also collaborating with our external stakeholders, which, importantly, also can contain our suppliers, our logistics partners, etc.," says Davuluri. "What we've also done is we've adopted a science-based ta rgets in it iat ive (SBTi) framework. We've pledged to achieve net zero emis- sions and align our targets with scientific guidelines. We intend to validate these with SBTi in the current financial year." Davuluri also sees the importance of having the company's sustainabilit y efforts externally evalu- ated. The company has adopted the S&P Dow Jones Sustainability Index framework. "We started off with a score of 48 in FY 23 and then in FY 24, we moved to a score of 64 and this year FY 25 we moved further up to a score of 70/100," Davuluri states. Challenges in small-molecule drug sustainability Because the chemistr y that produces the APIs in small-molecule drugs often use hazardous reagents, solvents, or intermediates, these drugs present certain challenges for sustainable manufacturing, according to Sahu. Process development must ensure PMI is low, but also, solvents, metal recycling, and reuse of waste- water must also be taken into consideration. "Ultimately, it is critical for both sustainability and economic security to ensure that the manufacturing process is designed for maximum efficiency, with a minimum number of high-yielding steps and a high degree of reproducibility," says Sahu. "This principle has remained a key requirement for small-molecule API manufacturing for over a century." Small-molecule drugs are resource intensive, accord- ing to Davuluri, and require a lot of energy and water. SUSTAINABILIT Y