"The US leads innovation, so if you are not heavily invested there in pharma, you are in trouble. Lots of our clients are shifting their production from Asia, so the US will remain critical to Evonik Health Care’s growth."

Stefan Randl & Paul Spencer

HEAD OF DRUG SUBSTANCE (SR), HEAD OF DRUG DELIVERY & PRODUCT (PS), EVONIK HEALTH CARE

May 31, 2023

Can you highlight Evonik Health Care’s main initiatives undertaken in North America in recent years?

PS: At Evonik, the service is designed to help clients get products to market faster by moving in both directions along the value chain, from the key excipients all the way to finished drug products for certain markets. In 2020, we acquired Wilshire in New Jersey, which was focused on plant-based excipients. That year we also bought another biodegradable polymer business called LACTEL, from Durect.

SR: On the drug substance side, the Lafayette, IN, site acquisition was a leap forward for our capabilities. It holds the world’s largest capacity for HP-APIs, a class of APIs that is growing at a fast pace. The US is a key market for us, it is where Evonik Health Care has some of our largest sites, and it is close to our major customers, which is why we recently moved the Drug Substance headquarters to the US. Our Tippecanoe site will remain a site of high investment. We are currently manufacturing lipids for BioNTech’s Covid-19 vaccine and other mRNA therapies in our plants in Germany. Together with the support of the US government, we will invest US$220 million in Lafayette so it becomes a world-scale lipid manufacturing facility to strengthen the US’ vaccine preparedness and to expand our lipid offerings and services for new mRNA therapies beyond Covid-19 vaccines.

How important will the US market be for Evonik Health Care in the coming years?

PS: The US is where innovation happens. The US leads innovation, so if you are not heavily invested there in pharma, you are in trouble. Lots of our clients are shifting their production from Asia, so the US will remain critical to Evonik Health Care’s growth.

SR: On the manufacturing side, there are concerns about supply security in the US, particularly considering the competition with and dependency on China. Smaller biotechs that are more prevalent in the US often like to see manufacturing close to their premises, at their doorsteps, and big pharma has been keener on manufacturing domestically.

What is Evonik Health Care’s competitive edge in the field of drug delivery?

PS: There is no threat that we become a pharma firm. A lot of drug delivery firms do so, as with the drug delivery model, you almost must become a pharma firm to get the appropriate valuations in the US. We do not need to worry about that, we are B4B. Evonik Health Care also brings supply security to the table.

SR: Evonik Health Care is very active in developing innovative excipients and formulations. One example is our partnership with Stanford University on innovative DNA/mRNA delivery technologies based on polymers as an alternative to lipids.

Can you speak to the importance of sustainability for Evonik Health Care?

SR: Our ambition is to be carbon neutral concerning Scope 1 and 2 emissions by 2030. We do a lot of recycling of the solvents that we use; we also piloted a program of recovery of metals, which we have now brought to a commercial scale. Using an Evonik membrane allows us to concentrate palladium in an organic waste stream, which is then shipped offsite to an external partner for recovery of the palladium. Also, we strive to improve the sustainability of our processes through chemical development. Among others, we use “Process Mass Intensity” as a measure for sustainability, which looks at the input vs the output of your process. Finally, we are developing innovative technologies. We work with Professor Lipshutz from Santa Barbara University on a technology called “Chemistry in Water”: the idea is to move away from organic solvents to aqueous-based reactions.

What will be the growth priorities looking ahead?

PS: We believe mRNA therapeutics are transformative. We made the investment in 2016, and the investments we are making in North America to better improve the delivery of drugs are crucial: beyond building a new, large plant for lipids, it is designed with multiple lines that can run several products consecutively. It is a transformative investment. We are focused on the future toward personalized medicine, and we believe that our capabilities of being able to quickly customize in all aspects along the value chain will make us a strong partner for pharma in such areas as cancer therapies.

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