Celonic Group and CARBOGEN AMCIS Launch Strategic ADC Partnership

Celonic Group and CARBOGEN AMCIS have established a strategic alliance to enhance the development and manufacturing of antibody-drug conjugates (ADCs). This partnership integrates both companies’ strengths, offering a comprehensive solution that spans from cell line development to commercial fill-finish.

The collaboration merges Celonic’s expertise in biologics with CARBOGEN AMCIS’s proficiency in payload synthesis, conjugation, and sterile manufacturing. By providing a single accountable partner, the alliance aims to support ADC innovators throughout the entire supply chain, streamlining processes and accelerating timelines.

Combining Strengths for Enhanced ADC Solutions

This partnership is particularly timely, as the demand for targeted cancer therapies continues to grow. Celonic, a contract development and manufacturing organization (CDMO) specializing in biologics, has recently expanded its Biologics Development Center located in Basel, along with its good manufacturing practice (GMP) manufacturing site in Heidelberg. This expansion includes the addition of high-yield GS-CHOvolution cell line capabilities and commercial-scale biomanufacturing suites.

On the other hand, CARBOGEN AMCIS has been providing ADC services since 2005 and boasts dedicated conjugation suites in Switzerland, as well as a commercial sterile manufacturing facility in France. This established infrastructure positions the partnership to effectively meet the evolving needs of the ADC market.

Dr. Samanta Cimitan, CEO of Celonic Group, remarked, “This strategic alliance is a direct response to the evolving needs of ADC innovators. By integrating Celonic’s advanced biologics platforms with CARBOGEN AMCIS’s world-class payload and conjugation capabilities, we’re enabling a fully harmonised development and manufacturing pathway, from DNA to drug product.”

A Streamlined Pathway for Clients

The integrated services offered through this partnership encompass cell line development and antibody production by Celonic, along with payload and linker synthesis, ADC conjugation, and sterile fill-finish by CARBOGEN AMCIS. Additionally, the partnership provides comprehensive regulatory support, including Chemistry, Manufacturing, and Controls (CMC) documentation for Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and Biologics License Application (BLA) filings.

This streamlined approach allows clients to collaborate with a single partner, thereby reducing variability and minimizing handoffs throughout the development process.

Stephan Fritschi, CEO of CARBOGEN AMCIS, stated, “Together, we offer a comprehensive service for ADC development, streamlined, scalable, and globally compliant.” By leveraging each company’s technical expertise and operational agility, the alliance positions itself to navigate the complexities of contract manufacturing in a rapidly evolving market.

As the pharmaceutical landscape increasingly focuses on innovative cancer therapies, this partnership between Celonic Group and CARBOGEN AMCIS stands to significantly impact the ADC development sector, addressing the growing needs of clients and enhancing the efficiency of bringing life-saving treatments to market.