Bachem leaders explore scale-up challenges

Bubendorf, Switzerland: –The latest ‘Voices’ article from peptide and oligonucleotide manufactures Bachem AG examines the challenges of scaling up TIDES production while retaining world-class quality.

The article invites perspectives from two people at the sharp end of the manufacturing challenge: Sebastian Hartmann, Vice-President of Manufacturing at Bachem’s Bubendorf headquarters in Switzerland, and Upinder Singh, VP of Production at Bachem USA in San Diego, California.

The challenges of growth

Demand for peptide APIs has increased significantly worldwide, compelling Bachem as a leading supplier to scale up its production. The demand cannot just be met by adding or expanding facilities, since the whole manufacturing environment has become more complex with increasing regulatory and sustainability demands.

Sebastian Hartmann and Upinder Singh both acknowledge that structural changes have been necessary to enable transitions to large-scale production.

Mr. Hartmann says the Manufacturing Division has experienced substantial changes over the past two years, with a more than doubling of workforce to 450 employees and facilities now operating at near-peak capacity.

“This expansion comes with its share of challenges, such as commissioning complex systems and introducing new shift schedules to optimize output. This transformation is possible thanks to an incredible amount of teamwork we’ve seen across the board, for instance between production and engineering teams,” he comments.

Upinder Singh comments that the Bachem Vista operation in the USA that specializes in manufacturing at batch scales up to 250 kg has been able to support clinical and early commercial customers and offer supplementary GMP manufacturing capacity to other Bachem sites.

Process changes

The two executives also reflect on the manufacturing process changes that have been required.

Sebastian Hartmann says Bubendorf has had to adopt 16/7 or even 24/7 shift patterns to maximize output.

“We’ve also fine-tuned our process approach to increase both efficiency and profitability. Collaboration across different divisions is a big part of this effort, as we work together to alleviate production bottlenecks, reduce downtime, and integrate new technologies into our processes,” he reflects.

Upinder Singh comments: “Safety, quality, and cross-functional communication are key pillars of our growth strategy. We’ve invested in capex, enhanced our daily production huddles, adopted lean workplace principles for better workplace organization, and conducted thorough assessments of our manufacturing suites and chemical storage. These changes streamline our process flow and ensure we’re operating efficiently, even at larger scales.”

The human dimension

The two men also discuss the measures needed to prepare employees for the scale of the changes required.

Bachem Bubendorf has developed specialized training courses for shift supervisors, preparing them for high-pressure situations. “Close cooperation between our teams and central functions has been key to maintaining smooth operations during this period of expansion,” says Mr. Hartmann.

At San Diego, there’s been strong emphasis on ongoing training to make the manufacturing team ready for large-scale production, which has included routine cGMP training, as well as education in Value Stream Mapping, lean manufacturing, and operational excellence tools like Minitab and visual management. “These initiatives help our team stay agile and effective as we scale up,” says Upinder Singh.

The quality challenge

As Bachem continues to scale, both Sebastian Hartmann and Upinder Singh emphasize a clear, shared vision: growth without compromising quality. Here, too, human factors are crucial.

“We’ve improved our employee training programs to reduce avoidable errors, and we hold daily floor meetings to discuss quality metrics and address any issues. Our division also participates in cross-divisional improvement initiatives to ensure that quality remains consistent throughout the entire production process,” says Sebastian Hartmann.

Upinder Singh adds: “Scaling up production doesn’t mean compromising on quality. We rely on standardized processes and equipment to maintain consistency as we increase output. Regular audits by both external and internal help us identify areas for improvement and ensure continuous enhancement of our quality standards.”

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 www.bachem.com

Resources

Click on Voices of Bachem: Scaling up for Success for further information
Click on Innovation at Bachem to learn more.
Click on Bachem Innovation for TIDES to download brochure.
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