Celonic Group

Celonic’s Strategic Alliance in ADCs

The Celonic Group and CARBOGEN AMCIS AG have formed a strategic alliance to offer a fully integrated Antibody Drug Conjugate (ADC) development and manufacturing platform. This partnership combines Celonic’s biologics expertise with CARBOGEN AMCIS’s payload synthesis and conjugation capabilities, creating a seamless, end-to-end solution for ADC developers.

In the evolving landscape of oncology drug development, few modalities have generated as much excitement—and complexity—as ADCs. These sophisticated biopharmaceuticals combine the targeting precision of monoclonal antibodies with the cytotoxic power of small-molecule drugs, offering a potent and selective approach to cancer treatment.

ADCs are designed to deliver their payload directly to tumour cells, minimizing damage to healthy tissue and reducing systemic toxicity. This targeted mechanism has established ADCs as one of the most promising therapeutic classes in oncology, with several blockbuster drugs already on the market and hundreds more in development.

Yet despite their promise, ADCs present formidable challenges in development and manufacturing. Their complexity spans multiple disciplines, including biologics, high-potency chemistry, conjugation, sterile fill-finish, and regulatory compliance. Fragmented supply chains and siloed contract development and manufacturing organisation (CDMO) services often lead to delays, quality issues, and increased costs.

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

The rise of ADCs in oncology
ADCs have emerged as a transformative modality in oncology, enabling targeted delivery of cytotoxic agents to cancer cells while sparing healthy tissue. The success of approved ADCs, such as:

  • Adcetris (brentuximab vedotin)
  • Kadcyla (trastuzumab emtansine)
  • Enhertu (fam-trastuzumab deruxtecan)
  • Trodelvy (sacituzumab govitecan)

has validated this therapeutic class and spurred a wave of innovation across the biopharmaceutical industry.

Growth and pipeline expansion
Analysts project the global ADC market to exceed $20 billion by 2030, with more than 200 ADC candidates currently in clinical development. This growth is driven by:

  • Advances in antibody engineering and linker technology
  • Improved understanding of tumor biology and target selection
  • Regulatory support for accelerated approval pathways in oncology
  • Demand for personalized and precision-based therapies

Challenges in ADC development
Despite their potential, ADCs are among the most complex therapeutic modalities to develop and manufacture. Key challenges include:

  • Biologics production: High-yield, scalable antibody manufacturing
  • Payload synthesis: Complexity and safe handling of highly potent cytotoxins
  • Conjugation: Precise attachment of pay-loads to antibodies
  • Sterile fill-finish: Safe and aseptic processing under strict containment
  • Regulatory compliance: Harmonized documentation across global markets

These challenges demand deep expertise, specialized infrastructure, and seamless coordination across disciplines—capabilities that few CDMOs can provide under one roof.

Complementary company strengths
The Celonic Group stands for: Innovation-driven biologics development and drug substance manufacturing. Founded in Basel, Switzerland, Celonic Group is a biologics-focused CDMO offering end-to-end services from DNA to drug product. With development and non-GMP manufacturing in Basel and GMP clinical and commercial manufacturing in Heidelberg, Germany, Celonic provides:

  • GS CHOvolution™ cell line platform for high-productivity antibody production
  • Upstream and downstream process development and process optimization
  • Analytical method development and validation
  • GMP manufacturing for clinical and commercial supply, including fed-batch, intensified and perfusion processes
  • Classical and process optimization tech transfers, including regulatory support

Celonic’s Heidelberg site features multiple biomanufacturing suites with fermenters ranging from 200L to 6 x 2,000L, as well as full perfusion reactors up to 1,000L scale for continuous processing.

“We pride ourselves on providing the technical expertise of larger, well-known CDMOs, but with the agility and collaborative mindset of a family-owned business,” said Dr. Samanta Cimitan.

CARBOGEN AMCIS: payload and conjugation leadership
Headquartered in Bubendorf, Switzerland, CARBOGEN AMCIS is a global provider of high-potency APIs, ADC payloads, and conjugation services. The company operates facilities in Switzerland, France, the UK, China and the Netherlands, offering:

  • Custom synthesis of cytotoxic payloads (e.g. auristatins, maytansinoids)
  • Linker design and scale-up (cleavable and non-cleavable)
  • GMP conjugation in segregated cleanroom suites
  • Sterile filtration and aseptic fill-finish for both liquid and lyophylized drug products
  • Analytical characterization and regulatory support

CARBOGEN AMCIS has made significant investments in infrastructure to support ADC manufacturing, including the expansion of its Aarau and Neuland sites, together with a long-standing customer.

“The rise of targeted cancer treatments has fueled growing demand for ADCs, and this alliance positions us to meet that demand with unmatched technical depth and operational agility,” said Stephan Fritschi, CEO of CARBOGEN AMCIS.

Why this partnership matters
The decision to form this strategic alliance was driven by several key factors:

Market demand: The ADC pipeline is expanding rapidly, with biotech startups and large pharma companies seeking turnkey solutions
Supply chain complexity: ADCs require coordination across biologics, chemistry, and sterile manufacturing—often involving multiple vendors
Regulatory pressure: Agencies such as the FDA and EMA are emphasizing integrated CMC documentation and quality systems
Speed to market: Oncology programs often operate under accelerated timelines, making delays costly and potentially life-threatening

By combining their capabilities, Celonic and CARBOGEN AMCIS provide a “one-stop-shop” for ADC development, reducing risk, improving quality, and accelerating timelines.

Scaling for commercial demand
Celonic has recently expanded its Biologics Development Center (BDC) in Basel, featuring Cytiva’s Xcellerex XDR single-use bioreactors, including advanced perfusion technologies. The Heidelberg site now includes both small-scale suites (200L to 1000L) as well as a larger 6 x 2000L asset for scaling up and out to support late-phase and commercial supply.

Celonic’s GMP facility in Heidelberg is equipped with state-of-the-art next-generation bioprocessing technologies and offers capabilities to significantly increase the amount of active ingredient produced. This reduces the cost per gram of finished drug substance, an important factor for ADCs.

CARBOGEN AMCIS’s Expansion
CARBOGEN AMCIS, together with a long-standing customer, is investing $32 million to expand its Aarau and Neuland sites, scheduled to be operational by 2027. These expanded facilities will support:

  • Commercial-scale linker and payload synthesis
  • Additional capacity to strengthen supply chain resilience
  • Enhanced containment and safety systems
  • Expanded conjugation capacity suitable for late-phase and commercial supply

“By investing in both Aarau and Neuland, we are ensuring that our infrastructure keeps pace with our customers’ ambitions,” said François Baduel, Chief Business Officer at CARBOGEN AMCIS.

Building the ADC value chain
The partnership operates under a joint, integrated program management model, with cross-functional teams managing client projects from early development through to commercial scale-up. Key integration points include:

  • Cell line and mAb process development (Celonic)
  • Drug substance manufacturing (Celonic)
  • Payload synthesis (CARBOGEN AMCIS)
  • Conjugation and fill-finish (CARBOGEN AMCIS)
  • Quality and regulatory support (Joint)

This operational synergy is expected to shorten development timelines, an important advantage in the competitive oncology space.

The difference compared with larger CDMOs
While global CDMOs offer scale and geographic reach, the Celonic–CARBOGEN AMCIS alliance provides a distinct set of advantages:

  • Deep specialization in ADCs
  • Agility and speed
  • Personalized collaboration
  • Purpose-built infrastructure
  • Regulatory expertise
  • Strategic location in the heart of Europe
  • End-to-end integration

Together, these advantages translate into accelerated timelines, higher quality, and stronger client relationships, providing a credible alternative to the traditional “one-stop shops” offered by larger CDMOs.

Contacts:
Media Contact – Celonic Group
Elisa Witt; Marketing & Communications
Elisa.Witt@celonic.com
+41 76 588 67 59

Media Contact – CARBOGEN AMCIS
Denise Neufeld
Marketing & Communications Officer
denise.neufeld@carbogen-amcis.com
+41 58 909 0384

This article was originally published in the Special CDMOs & CROs as part of European Biotechnology Magazine Autumn 2025.

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