Allen L. Burgenson
Global Subject Matter Expert, Associate Director
Lonza Walkersville, Inc.
Deahne Baker
Senior Director, Global Sustainability and Senior Legal Counsel
Marken
Jonathan Fuhr
Senior Manager, Global Sustainability
Marken
Rahul Mittal
Head Strategy & Innovation
Dr. Reddy’s Laboratories North America
Tuneer Ghosh
Executive Vice President and Head of CMC Services
Sai Life Sciences
How do you see the pharmaceutical industry’s approach to sustainability evolving over the next five years, and what regulatory pressures are driving these changes?
Allen L. Burgenson, Global Subject Matter Expert, Associate Director, Lonza Walkersville, Inc.: The broader scientific and ethical movement toward eliminating animal-derived reagents continues to gain momentum. Recombinant technologies such as rFC and rCR align with these principles by offering comparable performance without the need for animal sourcing. Their adoption reflects a growing industry commitment to sustainable, ethical, and scientifically robust testing practices.
Until all major compendia are harmonized on the recombinant endotoxin detection issue, end users will continue to face inconsistent regulations. It’s essential that the major compendia and regulatory bodies collaborate and establish a unified approach to help make recombinant methods the preferred method.
Deahne Baker - Senior Director, Global Sustainability and Senior Legal Counsel and Jonathan Fuhr - Senior Manager, Global Sustainability, Marken: There has been rapid growth in the adoption of sustainability goals worldwide over the past several years, and we expect this trend to continue. Driven by stricter regulations and customer / investor pressure, the industry is targeting sustainability initiatives more often as a primary strategic goal rather than a secondary consideration. In our industry, this is shaping up to become a determining factor for success. If a company is not adapting, innovating, and testing solutions, they will lose their competitive edge.
Sustainability can be broken into three focus areas for a well-rounded approach - environment, social and governance (ESG). This approach offers a foundation for a well-rounded approach. Science-Based Targets Initiative (SBTi) is the benchmark for setting actionable science-based commitments. A good deal of effort and progress is underway to achieve net-zero goals, with emphasis on Scope 3 emissions originating from transportation, purchased goods and services and other supply chain partners, including end-of-life packaging producers. Companies are choosing to allocate resources for a multitude of programs, including reverse logistics for packaging, regional sourcing strategies, and optimization of routing and transport strategies to minimize CO2 emissions including, but not limited to, biofuel implementation and fleet electrification.
On the social side, companies are setting initiatives as an inseparable part of their culture – from employee happiness and wellbeing to the impact made by an organisation in their local community. Companies, like Marken, focus their efforts on identifying and channeling their core competencies for the good of society at large - both local communities and those in developing nations. The need to work on ways to bridge the gap between those with and those without will drive increased pressure for lower drug pricing, complete transparency on sourcing and demonstrable commitment to patient access.
Finally, on the ESG pyramid, governance creates an engine of accountability. Global regulations, such as the EU’s Corporate Sustainability Reporting Directive (CSRD), and the IFRS Sustainability Disclosure Standards, will force standardized reporting, making ESG data as critical as financial data. Consequently, ESG metrics should be integrated into other organizational structures, ensuring sustainability performance is a core driver of responsibility and value creation.
Rahul Mittal, Head Strategy & Innovation, Dr. Reddy’s Laboratories North America: The pharmaceutical industry is expected to undergo a significant transformation in sustainability over the next five years, driven by both regulatory mandates and stakeholder expectations.
Pharmaceutical companies with their inherent nature of working with chemicals and intermediates are one of the key contributors to environmental pollution. Several Lifesciences companies are increasingly embedding sustainability into their core strategies, moving beyond compliance to proactive innovation.
This includes reducing carbon footprint and emissions and opting for renewal power sources, adopting green chemistry and manufacturing processes to replace toxic solvents and intermediates, implementing advanced water recycling systems that cut usage of fresh water by up to 40-50%. Supply chains are being restructured to minimize waste and improve transparency, while digitalization and data-driven tools are helping optimize production and distribution.
Importantly, sustainability is no longer seen as optional; it is becoming a competitive differentiator as patients, investors, and healthcare systems demand environmentally responsible practices.
Regulatory pressures are intensifying globally. European regulators, for example, are requiring greater environmental transparency and stricter standards for pharmaceutical manufacturing. At the same time, evolving regulations around personalized medicine, pricing transparency, and access to drugs are adding complexity. Compliance also adds to costs to business with payback and returns not directly measurable on the firm’s financial statements.
These pressures compel companies to balance innovation with compliance, ensuring that sustainability initiatives align with broader healthcare goals. Over the next five years, sustainability in pharma will likely shift from being a peripheral concern to a central pillar of operational and strategic decision-making.
What progress has been made in replacing animal-derived reagents—such as Limulus Amebocyte Lysate (LAL)—in endotoxin testing, and what are the main barriers to widespread adoption of recombinantalternatives?
Burgenson: The 3Rs—Replacement, Reduction, and Refinement—have been a guiding framework in the development of recombinant endotoxin assays. While the environmental impact of LAL production is considered minimal, the broader scientific and ethical movement toward eliminating animal-derived reagents continues to gain momentum. Recombinant technologies such as rFC and rCR align with these principles by offering comparable performance without the need for animal sourcing. Their adoption reflects a growing industry commitment to sustainable, ethical, and scientifically robust testingpractices.
Until all major compendia are harmonized on the recombinant endotoxin detection issue, end users will continue to face inconsistent regulations. It’s essential that the major compendia and regulatory bodies collaborate and establish a unified approach to help make recombinant methods the preferred method.
Mittal: There has been real progress in moving away from animal-based reagents like Limulus Amebocyte Lysate (LAL) for endotoxin testing. The main alternative is Recombinant Factor C (rFC), which works in a similar way but doesn’t rely on horseshoe crab blood. This makes it more sustainable and avoids the ethical concerns tied to harvesting crabs. Regulators have started to recognize these methods too, for example, the United States Pharmacopeia added guidance in 2024 that formally allows recombinant tests as valid options. Some pharmaceutical companies and labs are already using them, often alongside LAL, to make sure results stay consistent.
Still, there are hurdles. Not all regulators worldwide accept recombinant methods yet, and proving they work just as well as LAL takes time and resources. Many labs are used to LAL after decades of reliance, so switching means retraining staff and updating procedures. Costs can also be higher at first, and some remain cautious about moving away from a long-established standard. Overall, adoption is growing, but wider use will depend on global regulatory alignment, lower costs, and stronger confidence in the data.
How are in-silico modeling and other non-animal methods being integrated into clinical trial design and regulatory submissions, and what impact do these approaches have on reducing animal use and improving efficiency?
Mittal: In-silico modeling and other non-animal methods are increasingly being used to improve how clinical trials are designed and reviewed. These approaches rely on computer simulations, advanced algorithms, and human cell-based systems to predict how drugs will behave in the body. Regulators are beginning to accept such data as part of submissions, especially when it helps demonstrate safety or efficacy before moving to human trials. By using these tools, companies can reduce their reliance on animal testing, since many early-stage questions can be answered through modeling or lab-based alternatives. This not only addresses ethical concerns but also speeds up development, as simulations can quickly test multiple scenarios that would take much longer in animals. The result is greater efficiency, lower costs, and more targeted trials. While traditional animal studies are still required in some cases, the growing use of non-animal methods is steadily shifting the balance toward more humane and efficient science.
What strategies are companies implementing to reduce the carbon footprint of pharmaceutical manufacturing and logistics, and how are these efforts being measured and reported?
Baker and Fuhr: Scope 3 carbon emissions are a major focus for the pharma industry given they represent the largest portion of emissions throughout their value chain. These are primarily third-party emissions from purchased goods or services -- with major emphasis on logistics, manufacturing, and sourcing.
It is important to point out the pharma supply chain is complex and our mission is imperative. We must make time-sensitive and temperature-controlled deliveries no matter what. Ultimately, our shipments are saving lives. Integration of sustainability initiatives must be done without disruption. Simplifying multi-continent routes through various sourcing strategies and a strategically refined network of hubs minimizes air-miles, which can be key to significantly lowering emissions.
Likewise, a transition from multi-material plastics and polystyrene to lightweight, recyclable, or biodegradable packaging solutions will reduce our impact from both a waste management and emissions perspective. Several new packaging launches we have collaborated on this year provide lighter solutions (reducing emissions through air / road miles), increase recyclability and offer longer shelf-life for dry ice and reusable packaging (reducing waste). This is a growing strategy where we have seen great progress over the past several years.
Regarding measurement and reporting, we have found technology and collaboration are invaluable to progress. Recording the data for carbon emissions is a critical, multifaceted journey, and the findings must be auditable. Collaboration with third parties who help manage standardized processes, like ISO 14064, as well as use of the proper tools, to boost accuracy, accountability and transparency.
Mittal: Pharmaceutical companies are taking broad steps to cut the carbon footprint of their manufacturing operations, driven both by regulatory demands and growing expectations from stakeholders. A key priority has been shifting to renewable energy, with many plants now relying on solar, wind, or hydro power instead of fossil fuels. At the same time, green chemistry practices are being introduced to reduce the use of harmful solvents and energy-heavy processes, helping lower emissions throughout drug development. Supply chains are also being redesigned to follow circular models, such as recycling solvents, reusing water, and cutting down on packaging waste, which improves efficiency as well as sustainability. On the factory floor, energy efficiency upgrades like smart manufacturing systems and digital monitoring are making resource use more precise. Many companies have set ambitious net-zero carbon targets for 2030–2050, and progress is tracked through frameworks like CDP, SBTi, and lifecycle assessments. Annual ESG reports, often independently audited, provide transparency and ensure these efforts meet both regulatory standards and investor expectations.
Tuneer Ghosh, Executive Vice President and Head of CMC Services, Sai Life Sciences: Across the industry, we’re seeing a much more integrated approach to decarbonisation—one that combines renewable energy, energy efficiency, and action across the value chain rather than isolated initiatives. At Sai Life Sciences, this is very much how we think about it. Today, about 55% of our electricity comes from renewable sources, and our flagship manufacturing site already operates on 96% renewable electricity. We expect to reach 70% renewable electricity across operations by 2026, supported through unbundled I-RECs alongside direct sourcing.
Efficiency is just as important. We run ISO 50001–certified energy management systems and focus on practical interventions like waste heat recovery, condensate recovery, and combined heat and power. For residual emissions, we’re addressing fuel and refrigerant choices, including biomass trials and phased refrigerant replacement. Progress is tracked through detailed greenhouse-gas accounting and aligned with Science Based Targets, with transparent, externally assured reporting.
What are the most effective approaches for recycling single-use disposables in biopharma manufacturing, and how can companies overcome the technical and regulatory challenges associated with waste stream management?
Baker and Fuhr: It is important to note that the recyclability of secondary packaging is only one factor in determining whether it is the most sustainable option available. There are instances where a package’s ability to conserve resources or a lighter load may outweigh the inability to completely recycle the package during final disposal.
As such, there can be competing priorities and perspectives when it comes to sustainability in packaging, including preserving the performance of the packaging, extending its use-lifespan, increasing recyclability of the components and materials at end-of-life, as well as reducing production emissions or lowering transport emissions through reduced tare weights. Life cycle analysis offers a framework to objectively assess and compare packaging options across these sometimes-competing aspects, normalising these factors into a single, easily compared, footprint.
In our experience, this means a well-rounded packaging fleet is required to address shipping demands on a case-by-case basis, as well as providing customers with access to LCA data, allowing them to make informed choices.
End-of-life considerations are complex in healthcare given critical biohazard / safety regulations which may or may not allow complete recycling. Experts in the logistics space should be relied upon to ensure protocols are followed closely. As an example, many secondary packaging solutions contain insulation, cooling materials and primary packaging for specimens that require distinct handling processes to prevent contamination. Advanced packaging may contain multiple fused components or phase change materials, so it is worth speaking with your logistics specialist to understand what reusable options are available and working to keep reusable containers in circulation as long as they function properly, reconditioning them to perfection inside dedicated, clean and secure areas.
Mittal: Recycling single-use disposables in biopharma manufacturing is becoming a critical sustainability priority, given the industry’s reliance on plastics such as polyethylene, polypropylene, and polyvinyl chloride for bioreactors, tubing, and filtration systems. The most effective approaches focus on segregation, material recovery, and closed-loop recycling. Companies are increasingly implementing waste segregation at the source, ensuring that biocontaminated materials are separated from non-hazardous plastics to enable safe downstream processing. Advanced recycling technologies, such as pyrolysis and chemical depolymerization, are being explored to convert plastics back into usable raw materials, while mechanical recycling remains viable for non-contaminated disposables. Some firms are partnering with specialized waste management providers to establish closed-loop systems, where plastics are collected, sterilized, and reprocessed into new biopharma-grade products.
Overcoming challenges requires both technical innovation and regulatory alignment. Technically, the presence of biological contaminants makes recycling complex, necessitating sterilization methods that do not degrade material quality. Regulatory hurdles stem from strict GMP (Good Manufacturing Practice) requirements, which demand assurance that recycled materials meet safety and performance standards. Companies are addressing these issues by working with regulators to develop clear validation protocols, conducting lifecycle assessments to demonstrate environmental benefits, and publishing transparent ESG reports to build stakeholder trust. Collaboration across manufacturers, suppliers, and regulators is key to scaling recycling initiatives while maintaining compliance and product integrity.
How are advances in energy-efficient technologies—such as heat recovery systems, renewable energy integration, and smart manufacturing—being leveraged to improve sustainability in pharma facilities?
Burgenson: If the sensitivity, accuracy, and reliability of biosensors can be increased from their current level, that would mark a significant milestone in drug product manufacturing. The possibility of having in-line biosensors all along the manufacturing process shows substantial promise which would allow parametric release of a product, reducing or eliminating the need for end-product release testing. Such a processing regime is currently accepted by regulatory agencies around the world for many products.
Mittal: Advances in energy-efficient technologies are playing a pivotal role in improving sustainability across pharmaceutical facilities, where energy-intensive manufacturing and plant processes have traditionally contributed to high carbon footprints. Heat recovery systems are increasingly being deployed to capture and reuse waste heat from HVAC, sterilization, and manufacturing equipment, significantly reducing overall energy demand. By repurposing and reusing this thermal energy for water heating or facility climate control, companies are cutting both costs and emissions. Renewable energy integration is another major trend, with pharmaceutical plants investing in on-site solar arrays, wind turbines, and renewable power purchase agreements to transition away from fossil fuels. This shift not only lowers greenhouse gas emissions but also enhances resilience against energy price volatility. Meanwhile, smart manufacturing technologies including IoT-enabled sensors, AI-driven predictive maintenance, and advanced automation are optimizing energy use in real time. These systems allow facilities to monitor consumption patterns, detect inefficiencies, and dynamically adjust operations to minimize waste. Many companies are working on Manufacturing excellence and rethinking about the processes and identifying better chemistries that require lower energy consumption and designing the batch flow of production.
Together, these innovations are enabling pharma companies to align with global sustainability goals, meet tightening regulatory requirements, and demonstrate environmental responsibility to stakeholders. Over the next five years, the integration of these technologies is expected to transform pharma facilities into more sustainable, resource-efficient operations that balance productivity with climate commitments.
Ghosh: What’s encouraging is that many of the biggest gains are coming from proven, practical technologies rather than experimental ones. At Sai Life Sciences, waste heat recovery from boilers and evaporators allows us to reuse energy that would otherwise be lost. At our Manchester site, a combined heat and power system has improved overall energy efficiency by around 45%. These gains are complemented by greater use of renewables—off-site solar, wind power sourcing, and biomass boilers. Process innovation also plays a role. Continuous flow technologies, including plug flow reactors, continuous crystallisation, and LED-based photochemistry, reduce energy intensity and material waste while improving consistency and scalability. Sustainability, in this sense, becomes part of operational excellence rather than a parallel objective.
Beyond individual technologies and processes, what cross-functional initiatives or partnerships are needed to drive systemic change toward sustainability across the pharmaceutical value chain?
Baker and Fuhr: Collaboration can be invaluable to advancing objectives throughout the supply chain. Working together with clients and suppliers provides access to additional information which helps to improve data, hone workflows, define best practices, and harmonize transport. Pharma companies are developing vertical partnerships to form deep strategic alliances with logistics partners. Providing insight helps carriers plan for determining long-term shipments and goals for ESG, as well as the shared infrastructure strengthens the overall movement of goods and services contributing to emissions.
In pharmaceutical logistics, we’ve overcome many obstacles to accurately determine emissions savings, and we continue to build on our achievements. The processes require resources, and how these emissions are determined can depend on the acceptable method for tallying reductions. Recording and accurately auditing any emissions savings is a challenge. Again, this is where the third-party collaboration builds trust in their critical role.
The totality of the industry is gearing toward a more sustainable future, and savvy logistics partners are pioneering the way. ESG is a process by which you come to understand your organization on a deeper level, weighing the nuances to progress and refine function.
Mittal: Driving systemic sustainability across the pharmaceutical value chain requires coordinated initiatives that go beyond individual technologies or process improvements. Industry coalitions such as the Pharmaceutical Supply Chain Initiative (PSCI) are central to this effort, setting shared standards for safety, environmental responsibility, and social outcomes while offering tools like the Decarbonization Playbook to help companies collectively reduce emissions. Broader collaborations, including the Sustainable Healthcare Coalition and the SMI Health Systems Task Force, show how pharma firms, healthcare providers, and NGOs can co-develop scalable solutions for energy efficiency, waste reduction, and greener clinical practices.
Supplier engagement programs are critical, since Scope 3 emissions from suppliers represent the largest sustainability challenge and joint initiatives help standardize reporting, share renewable energy strategies, and co-invest in greener logistics.
Partnerships with technology and consulting firms further accelerate progress by embedding carbon tracking into digital supply chain management and manufacturing redesign. Multi-stakeholder platforms emphasize eco-friendly product design, circular economy practices, and collaborative innovation between regulators, academia, and industry. These partnerships provide scale, transparency, innovation, and resilience, though challenges remain around supplier readiness, data sharing, fragmented regulations, and upfront costs and the owner of the costs.
Ultimately, systemic sustainability depends on collective action across the entire value chain.
Ghosh: Beyond technology, sustainability across the value chain starts with clear expectations from customers and the responsibility to not only meet but, where possible, exceed them. At Sai Life Sciences, this means embedding sustainability into day-to-day decision-making, so customer requirements are translated into consistent operational practices rather than treated as compliance exercises.
That responsibility then extends to our suppliers, particularly given the significance of Scope 3 emissions. Active supplier engagement—through structured programmes, shared standards, and collaboration via industry platforms—is essential to drive meaningful progress beyond our own operations. We also take a broader view of sustainability, addressing areas such as water stewardship, biodiversity, and skills development to build long-term resilience. Ultimately, progress across the pharmaceutical value chain depends on aligning customer expectations, internal accountability, and supplier collaboration within a coherent sustainability strategy.
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