Scaling up peptide and oligo production

Bubendorf, Switzerland: – Bachem, the leading CDMO has developed a four-element strategy to increase its production capacity for peptides and oligonucleotides.

The plan will see substantial investments on both sides of the Atlantic to ensure secure supply of high quality active pharmaceutical ingredients (APIs).

Need for increased capacity

In an increasingly interconnected world, global events can profoundly impact all industries, including pharma. Recent disruptions, such as the Covid pandemic, increased geopolitical tensions, extreme weather events, and blockage of sea routes have all posed substantial challenges to the supply of active pharmaceutical ingredients (APIs) and thus the continuity of drug supplies.

Further, the world of peptide manufacturing is currently undergoing unprecedented changes with new diabetes and obesity drugs driving up demand for TIDE-based APIs, beyond current manufacturing capacity.

Recognizing this, Bachem has implemented a robust strategy to mitigate risks and ensure the continuous production and supply of high-quality APIs for drug manufacture.

Networked strategy

Bachem’s plans for increased production capacity are based on a network of sites in Switzerland, the UK and the USA, each with a particular part to play in the overall effort. This multiplicity is designed to better meet diverse customer demands, ensure greater robustness and security and enhance overall control over existing and future capacity.

For large-scale manufacturing, Bachem is expanding production facilities at its headquarters site in Bubendorf. Over the medium-term, it will create completely new large-scale facility at a greenfield site at Sisslerfeld in northwestern Switzerland. Further upstream, the Swiss Vionnaz site will increase its capacity to produce the amino acid derivatives that form the building blocks for peptides.

In the USA, the Vista site in California will be expanded to support large volume production, working in partnership with the Torrance facility that will handle smaller batch production.

Meanwhile the R&D-oriented Bachem UK plant at St. Helens in Lancashire will strengthen its expertise in research chemicals.

Building K at Bubendorf

The rising demand for peptides and oligonucleotides has placed high priority on bringing a new state-of-the-art production facility online at Building K on the Bubendorf campus.

The new facility will combine high-capacity production cells for scalable peptide and oligomer synthesis with advanced energy-saving heating, cooling, water, cold storage, and other systems, as well as a specialized tank farm for large-scale operations.

Since building commenced in 2021, the Building K project has expanded in scope to accommodate major long-term orders.

Greenfield site at Sisslerfeld

With the Bubendorf and Vionnaz nearing the limits of their room for expansion, Bachem has begun developing a completely new greenfield site near the town of Sisseln in Aargau Canton in northwestern Switzerland. The new Sisslerfeld site will focus on large-scale peptide manufacturing to ensure continuity of supply to meet market demands for decades.

This project represents one of the most ambitious industrial expansions in Switzerland. Latest project management standards are being applied to ensure its success, incorporating experience from previous large-scale builds. The first phase of development will begin with concept design in 2025.

Vista – larger batch production in the USA

A strategic investment is being made at the Vista site to address rising TIDES demand, aimed at significantly increasing peptide production capacity. This expansion is based around large-cale solid phase peptide synthesis (SPPS) reactors that can handle production volumes of up to one metric tonne at a time.

This large-scale production capacity will be further enhanced with a new Cleavage Equipment Train with twin filter dryers to enhance throughput, expanded Tank Farm & Waste Management to support high-volume operations, automated Glass Washer & New Heating/Chilling Systems for operational efficiency.

The Vista project has an ambitious timeline to bring it online as soon as possible.

St. Helens – expanding diagnostic peptide synthesis capabilities

A key challenge in peptide production is maintaining quality and efficiency at higher outputs. At St. Helens in the UK, a transformative partnership with an in-vitro diagnostic customer has kicked off significant advancements in the site’s peptide synthesis capacity.

The initial challenge was producing peptides at scale, requiring infrastructure upgrades. Over the past three years, synthesis methods have been refined, and the capacity has been further developed. As a result of these activities, St. Helens has doubled its output of diagnostic peptides.

Workforce expansion

Major global expansion also requires Bachem to grow its human capital. The company is looking to recruit a new generation of production professionals to support its advanced TIDES production methods.

It is also seeking graduate scientists to contribute to its groundbreaking innovations in peptide and oligo technologies.

About Bachem

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, 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, see https://www.bachem.com

Resources

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Click on Bachem as CDMO for Peptides and Oligos for further information.
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