Issue link: https://www.e-digitaleditions.com/i/1532595
14 Pharmaceutical Technology ® | BioPharm International ® Bio/Pharma Outsourcing Innovation February 2025 PharmTech.com SUSTAINABILIT Y sustainability procedures, according to Burns, and those companies often require contract manufactur- ing and development organizations to follow those procedures before signing a contract. According to Rajendra Kumar Sahu, chief execu- tive officer of Navin Molecular, standards required by sponsor companies may include EcoVadis certifica- tion and a minimum requirement of a bronze medal at the CDMO's last assessment. EcoVadis, founded in 2007, provides business sustainability ratings of more than 150,000 companies (2). Sponsors may also require science-based targets to reduce carbon emissions and the reporting of scope 1 and 2 carbon emissions. "Such importance is placed on these [criteria]; customers are beginning to refuse to work with suppliers that do not meet at least one of these standards, and there are a number of compa- nies making it clear that suppliers will be expected to be able to meet all three requirements/standards in the near future," stresses Sahu. "We used to see only Big Pharma or large generic drug companies having specific sustainabilit y re- quirements. But now a lot of small to mid-sized bio- tech companies are talking to us and evaluating us on our sustainability related practices," says Saharsh Dav uluri, vice-chairman and managing director, Neuland Laboratories. "One of our largest generic customers has required us to apply for the SBTi [Sci- ence Based Targets initiative] validation, which is something that we are seeing other companies follow as well. On the innovator side, we're seeing some of the large innovators enquire about our EcoVadis rat- ing, beyond the standard frameworks of assessments that are available." Contracting for sustainability CDMOs are meeting the expected sponsor require- ments and following regulations in a variety of ways to better serve their clients in meeting their sustain- ability goals. Contractors are taking different steps to achieve these goals. Brian Peutherer, vice president of Environment, Hea lt h a nd Sa fet y at Sterl i ng Pha r ma Solut ions, focuses on process efficiency when on-boarding a new project. "Routes are scouted, eva luated, and optimized in terms of the raw materials, solvents, energ y, complex capital equipment, strict storage and transport conditions, and complex waste man- agement solutions," he says. "Any amendment of a route to specifically include sustainable technologies or reagents must be balanced against the feasibility of scaling the process up. Options for quick, low-cost, small-quantity supply have different green chemis- try implications for large-scale, long-term supply. For example, a 'green' solvent may be feasible on a small scale but may not exist in suf f icient quantit y for larger volume requirements; and similarly, leverag- ing flow synthesis for a particular manufacturing step may be impractical for multi-kilogram production." Navin Molecular, according to Sahu, used environ- mentally based metrics to become a EcoVadis gold- rated site. They increased the share of electricity they used from renewable sources by 3% in 2023 to 24% in 2024. They also reduced their water consumption to 42% from recycled sources. "[T]he approach [to] de- veloping sustainable manufacturing processes does not only involve the replacement of hazardous sol- vents or heavy metals, but ensuring the chemistry is as atom-efficient as possible, and pushing the process mass intensity (PMI) to minimize energy consump- tion and waste production," Sahu says. "Our manufacturing approach is to always look for alternative practices that offer greater levels of sus- tainability, and leverage technology solutions where appropriate," says Sahu. "These can include adopting f low chemistry for certain reactions, which offers sig- nificantly lower energy and solvent consumption are significantly lower than the comparable batch-chem- istry approach, and/or enzymatic transformations in the place of precious-metal catalysts where reac- tions are often performed at ambient temperatures in aqueous media with minimal hazardous waste." Green chemistry techniques can reduce high sol- vent and energy use in large manufacturing plants, according to Harkin. "Enzymatic technology gener- ates molecules using more environmentally friendly techniques can negate the requirement for specialist equipment. In our experience, adopting green ap- proaches not only generates target molecules in a more sustainable way, but it is also more cost effec- tive," he says. Kindeva is specifically addressing sustainability in respiratory products and metered dose inhalers. The current propellants used in these products have unique challenges, according to Burns, and the in- dustry is making regulatory and legislative changes. "We are developing products on behalf of clients where they are looking for more environmentally friendly options, not just through choice, but actu- ally because legislation is dictating their transition needs to happen," says Burns. "So, part of our service is to work with clients, work with our equipment, our research and development, people who are experts in this field to produce more environmentally friendly options. European legislation is dictating that phase down of current [inhalation] products. It will start in 2027 and will finish in 2029, So, that's a three-year phase down period. Beyond that, the usage of exist- ing propellants within meter dose inhalers is going to be limited to a fraction of what it is now … We're see- ing a big switch over for a lot of companies who are looking to life cycle manage their existing portfolios,