COVID-19 pandemic highlights Propofol as Bachem success story

Bubendorf, Switzerland: – Bachem AG has succeeded in raising production of the active pharmaceutical ingredient (API) Propofol in response to escalating global demand in the face of the COVID-19 novel coronavirus pandemic.

The pandemic has rapidly expanded awareness of the API Propofol, produced by Bachem in Vionnaz, both as an intensive care sedative and also for potential therapeutic benefits.

Based on a prudent business continuity management plan, the Bachem Vionnaz site was able to raise production output immediately and rapidly implement capacity expansion plans that had already been prepared on a contingency basis. As a result, Bachem has been able to continuously supply all customers worldwide during the pandemic.

Propofol for intravenous anesthesia

Propofol, an anesthetic developed some 40 years ago by the former UK company ICI and approved since 1986 as an emulsion under the trade name Diprivan^®, is used to induce and sustain intravenous anesthesia. It is used with sophisticated syringe pump systems. One hour of standard anesthesia requires about one gram of the substance.

Because of its indisputable efficiency and importance as a general anesthetic agent in the operating theatre and a sedative for critically ill patients including those with COVID-19 in the ICU, propofol was listed as an essential drug by the World Health Organization (WHO) in 2016.

Anti-COVID indications

Even before COVID-19, propofol had been identified as a potential receptor agonist, with  clinically relevant (total) concentrations of the substance displacing the binding of (+)[³H]SKF-10047 (a selective σ1 receptor agonist) with a propofol K_i of 10.2 μM (K_i: a ‘measure’ of binding affinity)¹.

In a 2020 repurposing paper, Gordon and colleagues identified two sets of pharmacological agents displaying antiviral activity: inhibitors of mRNA translation and predicted regulators of σ1 and σ2 receptors². As σ1 and σ2 receptor antagonists suppress SARS-CoV-2, σ1 antagonist effects (by propofol) may provide a beneficial action against COVID-19. In addition, as propofol has both antioxidant and anti-inflammatory actions, it may reduce SARS-CoV-2-induced systemic inflammation and thereby provide organ protection³.

Propofol production at Bachem

The former Sochinaz facility in Vionnaz began developing a manufacturing process for the active ingredient of future generics in 1992. A Drug Master File was submitted to the FDA in September 1994. Actual production began in 2000.

In response to its immediate sales success, Bachem has continually improved the manufacturing process and our production equipment. Thanks to innovative technologies and highly automated equipment, its ‘greened’ manufacturing process is sustainable and solvent-free. Capacity has also steadily expanded, now capable of serving more than 200 million patients annually worldwide.

Bachem is a global market leader

Propofol’s market volume has grown steadily in recent decades, with the 2007 decision by the product’s inventor to purchase the substance from Bachem representing a significant milestone, affirming that the Vionnaz manufacturing process was superior to the original.

Bachem initially established contacts with China regarding Propofol in 2008, and in September 2009 received an initial import license enabling first sales. Prolonged efforts eventually led to the Chinese drug regulatory authority approving the Propofol Drug Master File in March 2019, opening the way to  substantial additional sales in the years to come.

“The persistent and sustained development work with Propofol over the past 30 years at the Vionnaz site has helped to make Bachem a global market leader. It goes without saying that we intend to hold onto this position in the decades to come. In doing so, we are proud to rely on a capable, motivated team which continually betters itself and never ceases to strive for new improvements,” the company said.

References:

1. Yamada,, Nakao, S., Sakamoto, S., et al., Propofol acts at the sigma-1 receptor and inhibits pentazocine-induced c-Fos expression in the mouse posterior cingulate and retrosplenial cortices. Acta Anaesthesiol Scand.2006; 50: 875-881. https://doi.org/10.1016/j.intimp.2019.105974
2. Gordon, D.E., Jang, G.M., Bouhaddou, M. et al.A SARS-CoV-2 protein interaction map reveals targets for drug repurposing. Nature 583, 459–468 (2020). https://doi.org/10.1038/s41586-020-2286-9
3. Zhaojian, Z., Liang, T, Kai, J., Propofol attenuates inflammatory response and apoptosis to protect d-galactosamine/lipopolysaccharide induced acute liver injury via regulating TLR4/NF-κB/NLRP3 pathway. International Immunopharmacology: Vol. 77, Dec 2019, 105974. https://doi.org/10.1016/j.intimp.2019.105974

About Bachem

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.

With 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.

Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia.

The company is listed on the SIX Swiss Exchange. For further information, visit the Bachem website.

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