Celonic and Leukocare Collaborate to Support Complex Biologics and Advanced Drug Development

Celonic, a Swiss-based biologics CDMO, and Leukocare, which provides drug product development services, entered into a collaboration to support biopharmaceutical companies developing increasingly complex biologics.

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

Celonic offers cell line and process development, process optimization, and clinical and commercial GMP manufacturing for advanced biologics. Company officials say its CHOvolution^® GS CHO‑K1 platform, supported by advanced transposase‑enabled integration, provides strong expression performance and is suited for both standard mAbs and complex molecules such as bispecifics and multispecific constructs.

Celonic is also a specialist in intensified and perfusion bioprocessing, having implemented next‑generation continuous and semi‑continuous upstream strategies that reportedly enable higher productivity, improved product quality, and more robust manufacturing outcomes, according to a Celonic spokesperson, adding that these intensified processes are particularly advantageous for bispecifics, multi‑domain constructs, and high‑concentration biologics.

Leukocare specializes in data science-driven drug product development for biologics and advanced therapeutic modalities, combining molecular modeling, predictive analytics, advanced biostatistics, Design of Experiments (DoE), and formulation expertise.

Celonic and Leukocare report that they will work together on client programs where their complementary expertise could create additional value. By considering formulation strategy, molecular characteristics, manufacturability, and process development in parallel, the companies aim to help clients establish strong development strategies at every stage of development from preclinical 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, explains Samanta Cimitan, CEO of Celonic.

“Our collaboration highlights the decisive role of formulation in enabling complex biologics to reach the clinic,” continues Cimitan. “By combining Celonic’s CHO‑based development, intensified and perfusion bioprocessing, and GMP manufacturing capabilities with Leukocare’s  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,” adds Michael Scholl, CEO of Leukocare. “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.”

The post Celonic and Leukocare Collaborate to Support Complex Biologics and Advanced Drug Development appeared first on GEN - Genetic Engineering and Biotechnology News.