CMC Development

New Chemical Entities (NCE)

 

Partner with the world’s leading peptide manufacturer for assistance in the development, production and regulatory support of your peptide active pharmaceutical ingredients (API).

Working with us, you’ll have access to our pioneering technologies and long-term expertise in chemistry manufacturing and controls (CMC) development. 

Join over 150 global GMP customer projects targeting New Chemical Entities (NCEs) that rely on our services, capabilities and products.

cmc development

Reach success with a bespoke plan

 

Achieve your goals with a tailored plan to meet your specific product development needs and smooth your journey to market. From manufacturing to release, we understand that each NCE project for peptides or oligonucleotides is unique, so we partner with you to make sure your product is developed in line with its individual requirements. Discover how we:

 

  • Supply API in appropriate and superior quality
  • Gather the necessary information for regulatory agencies
  • Facilitate quick study approval

 

A commitment to innovative CMC development services

Our commitment to innovative CMC (Chemistry, Manufacturing, and Controls) development services lies in offering cutting-edge solutions to streamline the drug development process. We utilize advanced technologies and expertise to support clients through the complexities of formulation, scale-up, and regulatory compliance. By embracing continuous innovation, we ensure that each project is tailored to meet evolving industry standards, facilitating the successful development of high-quality, market-ready products in a timely and cost-effective manner.

 

Comprehensive CMC services for every stage

 

 

Bachem offers comprehensive CMC services that support every stage of the drug development lifecycle. Whether it’s early-stage formulation, clinical trial material production, or post-market manufacturing, we provide end-to-end solutions. Our expert team ensures strict regulatory compliance, optimizes manufacturing processes, and guarantees the highest quality standards, enabling our clients to navigate each stage of development seamlessly and accelerate the delivery of life-changing therapeutics.

Our industry-leading CMC development services

Peptide NCEs

Reach global growth with research-grade material, refined process development and efficient GMP-grade large-scale production.

Oligonucleotide NCEs

Release the possibilities to perfect your oligonucleotide drug with our expert process development, GMP manufacturing and regulatory guidance.

Why work with us for CMC development?

 

  • Excellence – We provide you with the highest quality products and services in the industry.
  • Expertise – unmatched long-term knowledge in chemistry manufacturing and controls (CMC) development.
  • Innovation – We’re always looking for innovative solutions to ensure you achieve more.
  • Internationally approved – trust in our GMP compliance, with facilities inspected by the FDA, EMA and Swissmedic.
  • Sustainability – we understand the importance of ethical behavior and integrity in relation to long-term business success, so we’re dedicated to improving our economic, social and environmental sustainability.

 

sustainable large scale peptide api bachem-min

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

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