Oligonucleotide NCEs

Oligonucleotide
NCEs

Grounded in Bachem’s decades of experience in the development, production and regulatory support of API, Bachem is transforming into a contract development and manufacturing organization (CDMO) with a clear focus on the manufacture of TIDE molecules by expanding its manufacturing platform from peptides to oligonucleotides.

As can be expected from any Bachem initiative, this process is being executed meticulously and with a strong focus on innovation and quality. Our aim is to become the first-choice manufacturer also for oligonucleotides.

Similar to peptides, oligonucleotide therapeutics require expert knowledge in solid-phase synthesis and protecting group chemistry. Downstream processing typically includes purification by chromatography, ultra/diafiltration techniques, precipitation and lyophilization. The manufacture of peptide APIs follows the same basic principle and has been Bachem’s core technology for decades.

Gen Technik 7

What Bachem offers

Bachem already offers process development and GMP manufacturing services for synthetically accessible oligonucleotides in the multi –100g scale. Large-scale capacity will become available later in 2021. Bachem has thoughtfully designed an equipment train featuring some innovative engineering solutions for increased utilization flexibility and improved process control.

These new chemistry and manufacturing capabilities are completed with 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 API 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 oligonucletodide 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 trusting and long-standing partnerships. Our customers appreciate our broad knowledge, experience and expertise.
  • Innovation and technology – We are 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-term peptide manufacturing experience provides strong synergies for 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.

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.”

 

Gokhan Batur, CEO, Polyphor Ltd.

“As President and CEO of an emerging biopharmaceutical company, the selection process of a GMP API manufacturer was necessarily exhaustive. We have been pleased with the expeditious development activities and subsequent delivery of our novel API by Bachem. Moreover, Bachem continues to provide professional and timely post-production service.”

 

- Paul Gunn, President & CEO, Soricimed BioPharma Inc.

Oligonucleotide news

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