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Bachem is now expanding into Oligonucleotides


An interview with Torsten Wöhr, Head of Oligonucleotides at Bachem AG in Switzerland

The global market for oligonucleotide therapeutics is expanding rapidly. What is Bachem’s strategy in entering this competitive environment?
Dr. Torsten Wöhr*: I think it is important for our customers to understand that the decision by Bachem leadership to enter the field of oligonucleotide manufacturing was well-prepared and ultimately taken in line with the company’s long-term growth plan. We are operative since 2019 and are gradually expanding our expert resource pool, capabilities and capacity for oligonucleotides.
We have been lucky to forge strong partnerships on the customer as well as on the supplier side and have been able to hire great oligonucleotide chemists to accelerate our organizational learning. Despite having set ambitious goals we go step by step. Having said that, we more and more shifting our focus from closing the oligo-specific technology gap to building a solid foundation for future growth.
Our large-scale facility in fact will come online later in 2021. We took the time to thoughtfully design an equipment train featuring some innovative engineering solutions for increased utilization flexibility and improved process control.
Then, later on our way to become a first-choice manufacturer for oligonucleotides, we hope to make our own contributions to advancing the drug class by making oligonucleotide API production more scalable and cost-effective.

The CMO environment, in particular for oligonucleotides, is developing quickly. How do you see your chances of success and what do you think are the major hurdles?
TW: The progress in oligonucleotide-based drug development directly translates into a growing number of granted marketing authorizations. We actually might be seeing additional approvals before the end of the year. In addition, there is strong interest in the therapeutic application of antisense technology and non-coding RNA biology, which is reflected in an ever growing number of clinical programs in operation and in a global project portfolio that is spreading across a broader range of indications.
We therefore anticipate the demand for oligonucleotide custom manufacturing services to remain strong in the foreseeable future.
As for challenges: mastering oligonucleotide chemistry is not trivial, and building a track record of successfully completed scale-up projects is another major hurdle for every CMO entering the market. In addition, building large-scale manufacturing facilities for oligonucleotides, meaning facilities with an output of 1-Mol per batch or even more, is very expensive. At Bachem a sizeable CAPEX budget has been granted to purchase special equipment and to build the necessary infrastructure.
Finally, almost the entire equipment train is custom-built. It is important to get the design details right, ideally on the first pass. We are lucky to have a strong engineering team on site to support these critical activities.

What are the major technical challenges for the production of oligonucleotide therapeutics? Where can Bachem benefit from their expertise in peptide synthesis?
 TW: Similar to peptides, the manufacture of oligonucleotides requires expert knowledge in solid-phase synthesis and protecting group chemistry. Downstream processing typically includes purification by chromatography and isolation by ultra/diafiltration techniques, precipitation and finally lyophilization. The manufacture of peptide APIs follows the same basic principle. And it is the core technology Bachem has developed over decades.
Still, there are important differences between peptides and oligonucleotides. The synthesis in flow-through columns consumes large volumes of solvents and reagents for which our facility infrastructure will be appropriately expanded.
Furthermore, oligonucleotides are negatively charged and highly water soluble, requiring the handling of aqueous solutions throughout the entire downstream process.
And let’s not forget that oligonucleotide APIs, especially doubled stranded entities, are considerably larger then peptides and pose challenges also from an analytical point of view.
Overall, it is fair to say that our peptide manufacturing background and our analytical capabilities are certainly very helpful in our quest to build a successful oligonucleotide business.

COVID-19 exposes the weak links in the pharma supply chain. How has Coronavirus affected Bachem and your oligonucleotide development plans?
TW: Indeed, these are challenging times. COVID-19 affects all of us on a personal level, in our daily work life and social interactions.
Early on in the pandemic Bachem has received essential business status from the Swiss authorities, and our commitment is to our partners and patients, who depend on Bachem’s products and an uninterrupted drug supply.
Bachem’s corona task force monitors the COVID-19 pandemic closely and implements appropriate measures in a pro-active way. In addition, employees are repeatedly trained in preventing infections and reminded not to become complacent in the process.
So far the virus has not impacted Bachem’s ability to produce, and so is our oligonucleotide program still on track. Fingers crossed we continue navigating this situation successfully and can make a contribution in battling COVID-19.

*Torsten Wöhr, PhD, holds the position of Head of Oligonucleotides at Bachem AG in Switzerland.
Torsten Wöhr joined Bachem‘s Sales and Business Development team in 2017 to lead the company’s business with commercial products. In 2019 he accepted his current role to start up Bachem’s oligonucleotide program offering CMC development and manufacturing services for oligonucleotide drug substances. Torsten has more than 20 years of experience in customer-facing roles for chemical contract manufacturing (pharma/biotech) and life sciences companies. He studied biochemistry/molecular biology at the Swiss Federal Institute of Technology in Zürich (ETHZ) and obtained his doctorate in bio-organic chemistry from the University of Lausanne. He also holds a post-graduate degree in Industrial Engineering and General Management from ETHZ.

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