Basel, Switzerland / Martinsried, Germany 

Celonic AG, a Swiss-based biologics Contract Development and Manufacturing Organization (CDMO), and Leukocare AG, a leading provider of drug product development services, today announced a collaboration to support biopharmaceutical companies developing increasingly complex biologics.

The collaboration brings together Celonic’s expertise in cell line development, drug substance process development, intensified bioprocessing, and GMP manufacturing with Leukocare’s unique data science-driven approach to drug product development. By combining complementary scientific capabilities, the companies will support selected client programs involving complex biologics, including bispecific antibodies, multispecific antibodies, fusion proteins, and high-concentration formulations.

Celonic AG is a Swiss‑based, privately held biopharmaceutical CDMO with extensive capabilities across the full development and manufacturing lifecycle. The company provides cell line development, process development, process optimization, and clinical and commercial GMP manufacturing for advanced biologics. Celonic’s CHOvolution® GS CHO‑K1 platform, supported by advanced transposase‑enabled integration, provides strong expression performance and is well suited for both standard mAbs and complex molecules such as bispecifics and multispecific constructs.

Celonic is also a pioneer in intensified and perfusion bioprocessing, having implemented next‑generation continuous and semi‑continuous upstream strategies that enable higher productivity, improved product quality, and more robust manufacturing outcomes. These intensified processes are particularly advantageous for bispecifics, multi‑domain constructs, and high‑concentration biologics, where traditional fed‑batch approaches often face limitations.

Leukocare specializes in data science-driven drug product development for biologics and advanced therapeutic modalities. Combining molecular modelling, predictive analytics, advanced biostatistics, Design of Experiments (DoE), and deep formulation expertise, Leukocare develops rational formulation strategies that improve developability, manufacturability, and long-term product stability. Its integrated capabilities support clients from early developability assessment through formulation development, analytical characterization, stability studies, technology transfer, and CMC support.

Creating competitive advantages for clients developing complex molecules, bispecifics, and high‑concentration drug products

Through this collaboration, Celonic and Leukocare will work together on client programs where their complementary expertise can create additional value. By considering formulation strategy, molecular characteristics, manufacturability, and process development in parallel, the companies aim to help clients establish robust development strategies at every stage of development from pre-clinical development through to commercialization.

This integrated scientific approach enables a comprehensive understanding of each molecule and supports the development of drug products that are optimized not only for stability and manufacturability but also for scalable production and patient-friendly administration. “Our collaboration highlights the decisive role of formulation in enabling complex biologics to reach the clinic,” said Samanta Cimitan the CEO of Celonic AG. “By combining Celonic’s CHO‑based development, intensified and perfusion bioprocessing, and GMP manufacturing capabilities with Leukocare’s unique development expertise, we create measurable value for clients developing complex molecules, bispecifics, and high‑concentration drug products.”

“As biologics become increasingly sophisticated, formulation development must become more predictive, data-driven, and closely connected with process development,” said Michael Scholl, CEO of Leukocare AG. “Our collaboration with Celonic brings together complementary expertise that enables clients to make well-informed development decisions earlier, mitigate technical risk, and accelerate the path toward robust and manufacturable drug products.”

About the Collaboration

Celonic AG and Leukocare AG collaborate on client programs where integrated expertise in biologics development, drug product development, and manufacturing can help address the challenges associated with complex therapeutic modalities. By combining complementary scientific capabilities, the companies aim to support clients throughout development while each organization continues to operate independently and serve its respective global customer base.

About Celonic

Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO) with significant expertise in cell culture technologies, process development and manufacturing of recombinant proteins. Celonic’s roots trace back to 1982 as a spin-off of the Max Planck Institute in Germany. Today Celonic has a state-of-the-art Biologics Development and Innovation Center in Basel, Switzerland (Headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. This facility is equipped to handle complex biologics and bioprocessing technologies including fed-batch, N-1 perfusion and full perfusion production processes. At present, more than 500 highly qualified employees work at Celonic across the two locations.

About Leukocare

Leukocare AG is a leading service provider of data science-driven drug product development services for biologics and advanced therapeutic modalities. By integrating molecular modeling, predictive analytics, formulation science, advanced analytical characterization, and Quality-by-Design principles, Leukocare helps biotechnology and pharmaceutical companies design robust, manufacturable drug products while reducing development risk and accelerating timelines. The company’s integrated capabilities span developability assessment, formulation development, particle characterization, stability studies, technology transfer, and CMC support for complex biologics across the product lifecycle.

Celonic Group Contact Details

Elisa Witt

Marketing and Communications Manager

Elisa.Witt@celonic.com

M: +41 76 588 67 59

Leukocare Contact Details

Elena Schmudlach

Marketing and Communications Manager

elena.schmudlach@leukocare.com

Phone:  +49 (0) 89 / 780 16 65 – 226