CMC Development

CMC Development

With more than 50 years of experience in the development, production and regulatory support of peptide active pharmaceutical ingredients (API) for our customers, Bachem has long-term expertise in chemistry manufacturing and controls (CMC) development.

Since its foundation in 1971, Bachem‘s innovative concepts and technologies pioneered industrial peptide manufacturing and we are now expanding our core business into oligonucleotide manufacturing. With our track record, large-scale manufacturing and outstanding product quality, we are the leading partner in tides.

We currently have involvement in approximately 150 GMP projects targeting new chemical entities (NCEs) for customers across the globe.

What Bachem offers

Each NCE project for peptides or oligonucleotides is different, as Bachem partners together with companies to adapt a plan that meets the specific requirements of the product being developed, the needs from manufacturing and release, to help companies achieve their goals.

Bachem strives to help companies succeed by supplying API in the appropriate – and superior – quality and compile the necessary information for regulatory agencies in a way that facilitates quick study approval.

Peptide NCEs

We produce GMP-grade material, from simple peptides to the most complex peptidomimetics or synthetic proteins.

Oligonucleotide NCEs

The development and manufacturing of oligonucleotide-based API (GMP oligonucleotides) was a strategic decision based on the strong synergies with our broad peptide knowledge.

Why choose Bachem?

  • Customer centricity & service - At Bachem, we strive to give our customers an all-round positive experience - no matter who they are or where they are located.
  • Innovation and technology - Technological leadership and innovative strength have been the cornerstones of our success since the very beginning of our company.
  • Operational excellence and quality – Bachem is a leading and successful global player in the business of developing and manufacturing peptides and oligonucleotides.
  • People & culture – Our employees make the difference. Representing our corporate culture of passion and commitment, they are the foundation of our success.
  • Sustainability - We are committed to sustainability by taking responsibility towards our employees, the society, and the environment.

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.

Peptide & Oligonucleotide News

Peptide and Oligonucleotide knowledge

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