Oligonucleotide
NCEs

THERE IS AN INCREASING DEMAND FOR OLIGONUCLEOTIDE therapeutics

Emerging as a new treatment option in rare and orphan disease areas, oligonucleotide therapeutics have matured into a drug class with a broad indication spectrum. The promise of oligonucleotides making a difference to an increasing number of patients is driving Bachem’s rapid implementation of manufacturing capabilities and capacities for oligonucleotide-based APIs.

BACHEM WANTS TO BUILD A NEW FUTURE IN OLIGONUCLEOTIDEs

With decades of experience in the development, production and regulatory support of APIs, Bachem is extending its focus from peptides to oligonucleotides which leads overall to a transformation of the organization. As can be expected from Bachem, this transformation is being executed meticulously, with a strong focus on innovation and quality. Our aim is to become the first-choice oligonucleotide manufacturer.

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Similar to peptides, the manufacture of oligonucleotides requires expert knowledge in solid-phase synthesis, protecting group chemistry, purification by chromatography, ultra/diafiltration techniques, precipitation and lyophilization. In other words, Bachem has been able to tap into important technology and know-how synergies when establishing Contract Manufacturing Organization (CMO) services for oligonucleotide therapeutics.

What Bachem offers

Bachem will bring innovation to nearly every piece of equipment and process from the oligonucleotide synthesis to the isolation of the API. Bachem offers process development and GMP manufacturing services for synthetically accessible oligonucleotides in the multi–kg scale and has designed an equipment train with new engineering solutions for tight process control and high throughput.

These new chemistry and manufacturing capabilities are complemented by the support of Bachem’s exceptional analytical chemistry team and their long-standing expertise in developing and validating test methods for large and structurally complicated molecules.

Bachem offers a full range of CMC development services for oligonucleotide-based APIs starting with the establishment of scalable manufacturing processes and ending with IND and NDA applications supported by Bachem’s in-house regulatory affairs specialists.

The Bachem facilities are regularly inspected and approved by national and international regulatory authorities like FDA, Swissmedic and others. Copies of the certificates of GMP compliance, licenses and other documents can be found here.

A clear plan for developing the Chemistry, Manufacturing and Control (CMC), of peptide and oligonucleotide-based drug substances, affords our partners a risk-mitigated approach to any clinical and commercial milestones. Our interactions with regulatory authorities and sponsors around the world lends itself to a general plan (below), which is custom-tailored to every project.

Why choose Bachem?

Customer centricity & service – We offer the highest quality products and services in the industry and we stand for trusted, long-term partnerships. Our customers appreciate our broad knowledge, experience and expertise.
Innovation and technology – Bachem is passionate about innovation with a strong focus on realizing value in all areas of the company.
Operational excellence and quality – The pharmaceutical and biotechnology business requires the most stringent manufacturing standards and strives for absolute perfection in quality. Our long-standing peptide manufacturing experience gives strong synergies to our oligonucleotide production.
People & culture – Our employees make the difference. We are enthusiastic about technology and constant innovation and at the same time proud of our reliability and our solution–oriented, hands-on mentality.
Sustainability – We are convinced that ethically correct behavior and integrity are essential for long-term business success and we therefore continuously monitor and improve our social, economic and environmental performance.

With these vital ingredients, steeped in our proven track record of innovation, Bachem wants to transform oligonucleotides and ultimately transform patients’ lives.

What our customers are saying

"Theratechnologies is very pleased to be working with Bachem as a supplier of Tesamorelin. The experience has been very collaborative and contributed to the success of the development program all the way up to market approval. Certainly, Bachem's expertise in peptides, their professional project management and dedication to quality gives us great confidence in knowing we are with the right partner."

- Pierre Perazzelli, V.P. Pharmaceutical Development, Theratechnologies, Inc.

“Bachem is a strategic partner for all Polyphor programs including high quality large scale production of Balixafortide (POL6326) which we are advancing in a Phase III trial in combination with eribulin in patients with advanced breast cancer. Bachem’s collaborative approach with long term “win-win” business mindset and excellent project management gives us confidence for the future of our programs.”