Oligonucleotides, short strands of DNA or RNA, are gaining prominence as transformative tools in modern medicine. As their role in treating a range of diseases expands, the need for sustainable production methods becomes increasingly urgent. This article delves into how eco-friendly manufacturing practices can be implemented, their benefits, and the importance of selecting the right production partner.
Why Sustainability Matters in Oligonucleotide Manufacturing
The significance of sustainability in oligonucleotide manufacturing is growing due to the increasing use of these therapeutics in treating various conditions. With the oligonucleotide and peptide therapeutics market projected to grow at an annual rate of 17.5% before 2030, the industry faces several challenges, including high production costs, hazardous waste, and energy-intensive processes.
As the development and approval of oligonucleotide drugs rise, there is a pressing need for cost-effective and environmentally responsible manufacturing solutions. Sustainable practices help mitigate environmental impacts and address economic and regulatory pressures, fostering more efficient and accountable production methods.
How to Achieve Sustainable Oligonucleotide Manufacturing
Recent advancements make it possible to produce oligonucleotides more sustainably. By emphasizing waste reduction, recycling, efficiency improvements, and innovative synthesis techniques, manufacturers can lower their environmental footprint and operational costs.
Reducing Waste and Emphasizing Recycling
At Bachem, we have pioneered continuous chromatography technology for large-scale oligonucleotide purification. Our Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) system represents a major advancement in sustainable manufacturing. By recycling mixed fractions continuously, we have achieved over a 30% reduction in solvent use compared to traditional batch methods. This automated process operates around the clock, enhancing both sustainability and productivity by improving product yield and purity while potentially shortening cycle times by up to 70%. Initially developed for peptides, this technology has been successfully adapted for oligonucleotides.
Enhancing Yield and Quality
Maximizing yield and quality is essential for sustainable oligonucleotide manufacturing. Continuous chromatography processes, like MCSGP, offer higher capacity and yield while reducing solvent consumption compared to conventional batch methods. These processes, operating 24/7 through automated systems, significantly reduce purification cycle times. They improve efficiency and sustainability by lowering process mass intensity (PMI) while maintaining or even enhancing API quality, demonstrating that increased productivity and sustainability can coexist.
Lowering PMI with One-Pot Liquid-Phase Synthesis
Process Mass Intensity (PMI) is a key metric for sustainability in oligonucleotide manufacturing, measuring the total mass of materials used relative to the mass of the product. Traditional methods can result in high PMIs, with around 4300 kg of waste per kg of API for a 20-building block oligonucleotide.
Innovative approaches like one-pot liquid-phase oligonucleotide synthesis address this issue by combining solution-phase and solid-phase techniques. This hybrid method uses liquid anchor molecules or “tags” instead of solid-phase resins, allowing for higher volume yields and reduced solvent consumption. By eliminating excessive washing steps, this approach can potentially halve the PMI contribution from solvents.
Optimizing Capacity with Large-Scale Manufacturing
Bachem’s commitment to innovation is evident throughout the oligonucleotide manufacturing process. We have introduced unique engineering solutions to enhance product quality, scalability, cost-efficiency, and sustainability.
For example, we have customized large-scale oligonucleotide synthesizers with advanced process control and crude API purity improvements. In the cleavage and deprotection phases, our automated large-scale systems enhance both safety and efficiency.
Our expertise in peptide chromatography has enabled us to scale up purification processes for oligonucleotides, including the use of continuous chromatography technology on an industrial scale. This technology offers significant advantages, such as improved yields and purity, reduced solvent consumption, and lower PMI. Additionally, our proficiency in lyophilization and clean room operations ensures a smooth, high-quality isolation process without bottlenecks.
Fostering Employee Innovation
Bachem’s success stems from our commitment to technological leadership and innovation. We encourage all employees to contribute ideas and bring them to fruition. This culture of continuous improvement boosts efficiency, optimizes business processes, and identifies advanced manufacturing technologies.
Our positive, curious, and creative corporate environment nurtures this innovative mindset, setting industry standards in oligonucleotide production. We adhere to the latest GMP standards, with quality being a fundamental principle guiding our operations.
By actively engaging our workforce, we harness collective ingenuity to deliver superior products and services while navigating the evolving landscape of sustainable manufacturing.
Why Choose Bachem for Sustainable Oligonucleotide Manufacturing?
Sustainability is central to Bachem’s operations and culture. We adopt a comprehensive approach to our environmental and social responsibilities, continuously enhancing our performance through a robust Corporate Social Responsibility (CSR) management system.
Our commitment aligns with the United Nations Sustainable Development Goals, integrating ethical practices into our long-term success. We have earned a platinum medal rating for sustainability from EcoVadis, placing us among the top 2% of most sustainable companies. Additionally, we rank in the top 1% of companies in the manufacture of basic pharmaceutical products and preparations industry.
Our dedication to sustainability encompasses innovative technologies, efficient processes, and stringent quality standards. As a leader in sustainable solutions, we provide clients with the confidence to choose a manufacturing partner that prioritizes environmental stewardship, social impact, and ethical conduct while delivering world-class oligonucleotide production capabilities.
