Head of Corporate Development, Governance & Sustainability, BioSpring

Where Sustainability Meets GMP Excellence: Driving the Future of Oligonucleotide Manufacturing

For CDMOs working in therapeutic oligonucleotides, ESG is becoming more relevant, although the public debate may have become less visible in parts of the world.

As a supplier to biotech and pharmaceutical companies, we observe that ESG is becoming increasingly important, especially for larger organizations. Consequently, expectations regarding ESG performance and transparency across the supply chain are becoming more specific.

At the same time, meeting ESG expectations should be understood as part of a broader strategy to enhance long-term resilience, competitiveness, and stakeholder trust, rather than as a standalone objective. Recent global crises and increasing volatility have shown how closely sustainability and resilience are connected. Reducing energy and resource consumption, lowering dependency on critical inputs and strengthening supplier governance can also make supply chains more robust. In our industry, however, where patient safety is the ultimate objective, ESG must connect with how processes are developed, scaled, qualified, supplied and improved over time.

This operational connection is particularly important for oligonucleotide APIs. Solid-phase phosphoramidite chemistry has enabled an important class of medicines, including ASOs, siRNAs, guide RNAs and other nucleic acid-based modalities. These therapeutic advances, however, rely on a resource-intensive manufacturing process. Solvents, reagents, purification, water consumption, waste streams and scale-up complexity all become more relevant as programs move from early development into clinical and commercial supply. A process that uses resources more efficiently and economically avoids unnecessary waste and can be scaled in a controlled way.

At BioSpring, we look at ESG primarily through this operational lens. Our first responsibility is to provide high-quality nucleic acid APIs in a reliable and compliant manner. GMP compliance and product quality form the foundation of any framework to improve environmental and supply-chain-related aspects.

Energy and resource efficiency illustrate this approach well. BioSpring operates an energy management system aligned with ISO 50001 and continuously improves its energy performance through a combination of strategic initiatives and operational measures. We regularly inspect all cooling systems for refrigerant leaks to minimize energy losses and prevent emissions. Where feasible, we replace environmentally harmful refrigerants with more environmentally friendly alternatives to improve sustainability and reduce environmental impact.

Beyond energy efficiency, we apply the same sustainability principles to materials and waste. In regulated pharmaceutical manufacturing, resource efficiency must be balanced with contamination control and process robustness. Where feasible, extending equipment lifetime, refurbishing components, reducing avoidable material consumption and using solvent recycling already lower environmental impact while supporting stable operations.

We strive to reduce the use of single-use materials by introducing more sustainable alternatives whenever possible. Any replacement is carefully assessed to ensure full compliance with GMP requirements and product quality standards.

Significant opportunities to reduce the environmental impact of oligonucleotide production can often be realized through process development. Decisions around necessary solvents, purification strategies, and quality and yields strongly influence the environmental profile of a program. We believe that sustainable process development starts with technical decisions that reduce resource intensity while maintaining or improving impurity control and overall process performance.

We have successfully developed a new synthesis process using an alternative solvent with a lower environmental impact. Its implementation in production is now beginning, marking an important step towards more sustainable manufacturing while maintaining the required quality and regulatory standards.

Digitalization is a prerequisite for effective ESG management. In a GMP environment, success depends on reliable, structured and auditable data. BioSpring's digital environmental and ESG management systems help transform operational data into actionable insights that support transparency, performance monitoring and informed decision-making. This is the basis for internal evaluations, customer questionnaires, supplier assessments and future reporting requirements.

Supplier selection is increasingly influenced by ESG criteria, as sustainability becomes a key consideration in procurement decisions. CDMOs are increasingly asked to provide assurance not only on their own operations, but also on the upstream supply chain: raw materials, critical suppliers, logistics, documentation, business continuity and, increasingly, environmental and social criteria. BioSpring integrates ESG criteria into its Supplier Code of Conduct and purchasing guidelines, including considerations such as the sustainability and carbon footprint of purchased products, as supplier selection in pharmaceutical manufacturing cannot be based on price and availability alone. For critical materials, technical quality, continuity of supply, responsible procurement and ESG-related transparency must be evaluated together.

Our sustainability efforts are supported by our ISO 50001-certified energy management system, our EcoVadis and CDP assessments, and our commitment to the Science Based Targets initiative (SBTi) Near-Term Target. We seek to work with suppliers who share our commitment to sustainability and encourage them to implement comparable environmental and climate initiatives.

The supplier perspective highlights the close connection between ESG and resilience. Climate events and geopolitical tensions causing supply chain disruptions and trade conflicts, as well as regulatory changes can all affect critical materials. Supplier risk management therefore has to consider both sustainability and supply security. Updated risk management, additional KPIs, supplier mapping, and qualification of additional suppliers can help reduce dependencies and improve transparency.

Resilience and ESG are most effective when they are addressed together. By integrating ESG considerations into risk management and business continuity planning, companies strengthen both supply security and long-term sustainability. This enables BioSpring to maintain reliable delivery to customers and, ultimately, to patients, while upholding its ESG commitments even under challenging conditions.

Looking toward 2030 and beyond, technical expertise, GMP compliance and reliable manufacturing capacity will remain essential. Equally, CDMOs will be expected to provide credible ESG data, understand the sustainability impact of process and supply-chain decisions, support their customers' decarbonization goals, and contribute to more resource-efficient manufacturing.

For oligonucleotide therapeutics, this will be especially important as the field matures and more programs move toward larger clinical and commercial volumes. At BioSpring, ESG is an integral part of how we develop processes, manufacture oligonucleotides, and work with our partners, always with patient safety as our highest priority.