The Drug Substance unit within Evonik’s Health Care business encompasses the company’s contract development and manufacturing organization (CDMO) services for active pharmaceutical ingredients (APIs) and intermediates as well as its portfolio of API products. Building on strong piloting and world-scale facilities in the U.S. and Germany, the Drug Substance unit supports customers with scale-up from clinical phases to commercial production, including large-scale high potency APIs (HPAPIs) and multi-step complex APIs.
 
Two key milestones over the past 12 months include the opening of a new facility for clinical and launch quantities of pharmaceutical lipids in Hanau, Germany and officially breaking the ground on a $220 million commercial lipid facility in Lafayette, Indiana—supported with funds from the U.S. Government.
 
Other highlights from the Drug Substance unit include the collaboration with Phathom Pharmaceuticals to manufacture the novel acid blocker vonoprazan, and the partnership with Heraeus Precious Metals to expand both companies’ range of services for HPAPIs. In terms of development projects, the Drug Substance business is working on a range of mPEGs of various molecular weights with tight polydispersity specifications for use in various pharmaceutical applications.

Sustainability Leadership

Evonik is a leader in the industry for sustainability, committed to Science Based Targets initiatives (SBTi), with the goal of being climate neutral by 2050. This target is even more ambitious in the Health Care business, which aims for carbon neutrality in Scope 1 and 2 (direct and indirect emissions) by 2030.
 
In this Q&A, Evonik Health Care’s Global Head of Drug Substance Sales, Eric Neuffer, discusses how the company is achieving its sustainability initiatives, as well as the benefits and challenges of implementing green chemistry.

Contract Pharma: How can the pharmaceutical industry maintain strict safety standards while improving its environmental performance?

Eric Neuffer: Strict safety standards are not necessarily at odds with environmental sustainability. By adopting sustainable practices such as reducing waste, using renewable energy sources, adopting green chemistry principles, and investing in research and development of environmentally friendly technologies, the pharmaceutical industry can improve its environmental credentials while maintaining safety standards. Regulatory bodies can also play a key role in incentivizing and enforcing green practices through guidelines, certifications, and penalties for non-compliance. Increased collaboration and knowledge sharing within the industry is also another way to develop innovative solutions that reduce the environmental impact of pharmaceutical manufacturing while ensuring patient safety and efficacy.

CP: What technological advances are available to implement green chemistry?

Neuffer: Creativity and innovation are cornerstones of the pharmaceutical industry, and it is exciting to see what happens when that energy is invested in green chemistry. One example of a technological advance is the use of continuous flow chemistry, which allows the precise control of reaction conditions and reduces the amount of waste produced. Another great example is the use of renewable feedstocks (ex. sugar cane for fermentation) and solvents (ex. ethanol & 2-MeTHF), which can reduce reliance on fossil fuels and minimize the environmental impact of the production process.

The development of more efficient catalysts that can be recovered, and the implementation of purification techniques can further reduce waste and improve the efficiency of the manufacturing process are also great advances in sustainability. At Evonik we are working on a technology called Chemistry in Water created by Professor Bruce Lipshutz from UC Santa Barbara in the U.S., where surfactants are used to create micelles in which reactions take place, thereby reducing the need for solvents in chemical synthesis. Fermentation also contributes to sustainable manufacturing practices, as water is a typical solvent, and reduced environmental impact.

CP: How can route selection, which is an essential in R&D and manufacturing, be optimized?

Neuffer: Route selection can be optimized to be greener by considering the environmental impact of each potential synthetic route. This includes evaluating factors such as energy consumption, waste generation, and the use of hazardous materials. Green chemistry principles can also be applied by designing more sustainable reactions, such as those that produce less waste or use renewable energy sources. One example is the use of biocatalysts, which are enzymes that can catalyze reactions with high selectivity and efficiency, reducing the need for harsh chemicals and solvents. In addition, process intensification techniques such as continuous flow chemistry can minimize waste and energy consumption by reducing the scale of reactions and improving reaction efficiency. We expect to see more green chemistry and sustainability experts help further optimize the route selection process.

CP: Are innovators developing synthetic routes that are less green to remain competitive from a time and cost perspective?

Neuffer: While it is difficult to make a blanket statement, some drug substance innovators may prioritize time and cost over green considerations. However, the pharmaceutical industry is becoming increasingly aware of and committed to sustainable practices. The generics industry, which enters the market after patents expire, can leverage the experience of innovators, and improve processes. For example, they can reduce the E-factor (waste per unit) and PMI (material efficiency) by implementing greener manufacturing methods. This can lead to cost savings, reduced environmental impact, and potentially a competitive advantage, as sustainability becomes an important factor in the industry’s landscape.

CP: How can green approaches help strategize to make any business model attractive?

Neuffer: Business models can become more attractive by reducing environmental impact and improving sustainability. Companies can appeal to their consumers (B2B or B2C) who are increasingly environmentally conscious and may choose to support those businesses that prioritize sustainable practices. We are seeing this in various forms in our client engagements, typically with many large pharmaceutical companies leading the way.

In addition, green approaches to drug substance manufacturing can also provide economic benefits. For example, using renewable energy sources and reducing waste production can save costs on raw materials and disposal. Implementing green chemistry principles can also lead to the development of more efficient and economical synthesis routes, ultimately improving the overall manufacturing process. Green initiatives can also help companies comply with regulatory standards and avoid potential fines or penalties for environmental violations.

By proactively implementing sustainable practices, businesses can demonstrate their commitment to environmental responsibility and enhance their reputation among stakeholders. Overall, integrating green approaches in drug substance manufacturing can have far-reaching benefits, including increased consumer appeal, reduced costs, and improved environmental sustainability, ultimately contributing to effective business models.

CP: Which sustainability initiatives are emerging in your business?

Neuffer: Evonik prioritizes sustainability and sustainability aspects are becoming increasingly important to gain the trust and support of customers, investors, and regulatory bodies. At Evonik Health Care, we are fully committed to reducing our carbon footprint and are actively working on initiatives for reducing our scope 1, 2 and 3 emissions. Further, we are committed to the global Science Based Target Initiative (SBTi). To achieve our ambitious targets of being carbon neutral in scope 1 and 2 emissions by 2030, we have established internal programs and extensive collaborations with our customers and suppliers.

CP: How do you address manufacturing challenges through green chemistry?

Neuffer: Evonik addresses drug substance and intermediate manufacturing challenges through green chemistry by prioritizing sustainable and efficient processes. We focus on developing greener synthetic routes, optimizing catalytic processes, and selecting more environmentally friendly solvents. Evonik also promotes the use of renewable feedstocks and bio-based starting materials, reducing reliance on fossil resources. Process intensification, such as continuous flow chemistry and automation, is employed to enhance efficiency and minimize resource consumption.

Additionally, Evonik emphasizes the use of safer and more sustainable reagents and reaction conditions. Through these approaches, Evonik strives to minimize waste generation, energy consumption, and environmental impact in drug manufacturing. Through these approaches, Evonik actively addresses drug substance and intermediate manufacturing challenges by incorporating green chemistry principles. By optimizing synthetic routes, using renewable feedstocks, intensifying processes, and prioritizing safety and sustainability, Evonik contributes to greener and more sustainable practices in the pharmaceutical industry.

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